Document text
Page 1 of 840
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980057
Page 2 of 840
***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: 11161224 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/11/2020
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980058
Page 3 of 840
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11161224]
2.Birth Date: /1968
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980059
Page 4 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980060
Page 5 of 840
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980061
Page 6 of 840
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980062
Page 7 of 840
***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: 11161224 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:[Acid Reflux]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2008
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980063
Page 8 of 840
***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: 11161224 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:[Gastric Sleeve Surgery]
Start Date: Oct/UNK/2015
Ongoing: NO
End Date:
Oct/UNK/2015
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Three Herniated Disc L2, 4 and 5]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Breast Augmentation Cosmetic]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980064
Page 9 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Ovarian Cyst]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Oopherectomy]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gall bladder removal]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gall Stones]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980065
Page 10 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tilted Uterus]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Arthritis Knee]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Knee Meniscus Torn]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980066
Page 11 of 840
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
2.Weight: [184.8]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [27.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980067
Page 12 of 840
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980068
Page 13 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/11/2020
2.Randomization Number: [88695]
3.Randomization Group: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980069
Page 14 of 840
***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: 11161224 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/11/2020
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 [BPTYH9]
5.bSample ID [BPTYHB]
5.cSample ID [BLBFN3]
5.dSample ID [BLBFN4]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980070
Page 15 of 840
***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: 11161224 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/11/2020
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 [BPTYFZ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980071
Page 16 of 840
***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: 11161224 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/11/2020 16:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980072
Page 17 of 840
***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: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980073
Page 18 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980074
Page 19 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980075
Page 20 of 840
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/30/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980076
Page 21 of 840
***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: 11161224 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/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 [BP4167]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980077
Page 22 of 840
***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: 11161224 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/30/2020 09:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980078
Page 23 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980079
Page 24 of 840
***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: 11161224 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:
Oct/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 [BPMFP2]
5.bSample ID [BPMFP3]
5.cSample ID [BR6301]
5.dSample ID [BR6302]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980080
Page 25 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980081
Page 26 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/16/2020
2.Date of First Symptom Started: Nov/14/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/20/2020
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980082
Page 27 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.aSymptoms - Other Text: [Dry Throat]
5.bSymptoms - Other Text: [Headache]
5.cSymptoms - Other Text: [Itchy Throat]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980083
Page 28 of 840
***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: 11161224 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.Nov/15/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
2.Nov/14/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980084
Page 29 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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: Nov/15/2020
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: [Subject was also tested on 14NOV2020 with a negative result]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980085
Page 30 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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: Nov/14/2020
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: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980086
Page 31 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Collected In Clinic]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980087
Page 32 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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:
Nov/16/2020
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 [BP40W6]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980088
Page 33 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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:
[2]
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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980089
Page 34 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980090
Page 35 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980091
Page 36 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980092
Page 37 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980093
Page 38 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 Infection]
Date of Diagnosis:
Nov/16/2020
3.Toxicity Grade: 2
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980094
Page 39 of 840
***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: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980095
Page 40 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980096
Page 41 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 Id
entifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980097
Page 42 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980098
Page 43 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980099
Page 44 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980100
Page 45 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980101
Page 46 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980102
Page 47 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980103
Page 48 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980104
Page 49 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980105
Page 50 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980106
Page 51 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980107
Page 52 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980108
Page 53 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Nov/16/2020 Record Identifier: Systolic: Diastolic:
1 124 78 Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980109
Page 54 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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: Nov/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [124]
Diastolic: [78]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [98]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980110
Page 55 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Nov/16/2020 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980111
Page 56 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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: Nov/16/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980112
Page 57 of 840
***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: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980113
Page 58 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980114
Page 59 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980115
Page 60 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980116
Page 61 of 840
***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: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980117
Page 62 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980118
Page 63 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: 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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980119
Page 64 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/23/2020
2.Date of First Symptom Started: Dec/20/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/15/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980120
Page 65 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.Symptoms - Other Text: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980121
Page 66 of 840
***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: 11161224 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.Dec/22/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980122
Page 67 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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: Dec/22/2020
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: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980123
Page 68 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: 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: 11161224 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_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[COLLECTED IN CLINIC]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980124
Page 69 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: 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: 11161224 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:
Dec/23/2020
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 [BP40WW]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980125
Page 70 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980126
Page 71 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Dec/23/2020 NO
Discharge Date:
Dec/25/2020
Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980127
Page 72 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/23/2020
4.Ongoing? NO
Discharge Date:
Dec/25/2020
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980128
Page 73 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980129
Page 74 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980130
Page 75 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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:
Dec/22/2020
3.Toxicity Grade: 1
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980131
Page 76 of 840
***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: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980132
Page 77 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980133
Page 78 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for Lab
TestVendor NameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.CLINICAL CHEM
ISTRY Memorial Hosp
ital
4500 Thirteenth
Street
Gulfport, MS 3
9502 Dec/22/202
0 BLOOD Sponsor-Defined I
dentifierTest:Resu
lt:
329 Not Do
ne
30 Not Do
ne 15
28 Not Do
ne 36
35 Not Do
ne 140
21 Not Do
ne
47 Not Do
ne 28
48 Not Do
ne 4.5 Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980134
Page 79 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY Comments
2.Laboratory Name and Address [Memorial Hospital
4500 Thirteenth Street
Gulfport, MS 39502]Comments
3.Collection Date: Dec/22/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [329] Comments
Test: C Reactive Protein_PX329
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [15] Comments
Not Done: Comments
LNMT Low
[7]
High
[56]
Unit
mg/dLComments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980135
Page 80 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.cSponsor ID: [28] Comments
Test: Aspartate Aminotransferase_PX28
Result: [36] Comments
Not Done: Comments
LNMT Low
[5]
High
[35]
Unit
mg/dLComments
5.dSponsor ID: [35] Comments
Test: Alkaline Phosphatase_PX35
Result: [140] Comments
Not Done: Comments
LNMT Low
[38]
High
[126]
Unit
mg/dLComments
5.eSponsor ID: [21] Comments
Test: Bilirubin_PX21
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980136
Page 81 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: [47] Comments
Test: Blood Urea Nitrogen_PX47
Result: [28] Comments
Not Done: Comments
LNMT Low
[7]
High
[21]
Unit
mg/dLComments
5.gSponsor ID: [48] Comments
Test: Creatinine_PX48
Result: [4.5] Comments
Not Done: Comments
LNMT Low
[0.5]
High
[1.4]
Unit
mg/dLComments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980137
Page 82 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980138
Page 83 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980139
Page 84 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980140
Page 85 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980141
Page 86 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980142
Page 87 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980143
Page 88 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980144
Page 89 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Dec/23/2020 Record Identifier: Systolic: Diastolic:
1 107 77 Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980145
Page 90 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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: Dec/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [107]
Diastolic: [77]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [104]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980146
Page 91 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Unknown Record Identifier: Oxygen Saturation
Unknown Unknown Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980147
Page 92 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Unknown
//Comments
Vital Signs Details
2.aRecord Identifier: Unknown
1
SPO2 Pulse Oximetry % Unknown
[ ]Comments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980148
Page 93 of 840
***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: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980149
Page 94 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980150
Page 95 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980151
Page 96 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980152
Page 97 of 840
***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: 11161224 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
2.Dec/22/2020 CHEST X-RAY UNKNOWN Repeating Pages
3.Dec/22/2020 OTHER
If other, specify:
abdominal
CT SCAN NORMAL Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980153
Page 98 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980154
Page 99 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/22/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: UNKNOWN
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980155
Page 100 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/22/2020
2.Location of Assessment: OTHER
If other, specify:
[abdominal]
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980156
Page 101 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: 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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980157
Page 102 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/11/2021
2.Date of First Symptom Started: Feb/10/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/15/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980158
Page 103 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.Symptoms - Other Text: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980159
Page 104 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980160
Page 105 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980161
Page 106 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: 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: 11161224 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_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[COVID Illness visit did not occur]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980162
Page 107 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: 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: 11161224 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[COVID illness visit did not occur]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980163
Page 108 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980164
Page 109 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980165
Page 110 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980166
Page 111 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980167
Page 112 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980168
Page 113 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980169
Page 114 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980170
Page 115 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980171
Page 116 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. DELETED Not Appl
icable Not Appl
icable Sponsor-Defin
ed IdentifierTest:Res
ult:
[ ] C Reactive Protein
_PX329 [ ]
[ ] Alanine Aminotran
sferase_PX30 [ ]
[ ] Aspartate Aminotr
ansferase_PX28 [ ]
[ ] Alkaline Phosphata
se_PX35 [ ]
[ ] Bilirubin_PX21 [ ]
[ ] Blood Urea Nitrog
en_PX47 [ ]
[ ] Creatinine_PX48 [ ] Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980172
Page 117 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type:
Lab Result
5.aSponsor ID: [ ]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [ ]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980173
Page 118 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.cSponsor ID: [ ]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [ ]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [ ]
Test: Bilirubin_PX21
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980174
Page 119 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
5 fSponsor ID: [ ]
Test: Blood Urea Nitrogen_PX47
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [ ]
Test: Creatinine_PX48
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980175
Page 120 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Hemoglobin_
PX1 Not D
one
Not Done Hematocrit_P
X2 Not D
one
Not Done Erythrocytes_
PX3 Not D
one
Not Done Platelets_PX5
Not D
one
Not Done Leukocytes_P
X7 Not D
one
Not Done Neutrophils_
PX608 Not D
one
Not Done Eosinophils_
PX609 Not D
one
Not Done Monocytes_P
X612 Not D
one
Not Done Basophils_PX
610 Not D
one
Not Done Lymphocytes
_PX611 Not D
one Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980176
Page 121 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980177
Page 122 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980178
Page 123 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980179
Page 124 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980180
Page 125 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980181
Page 126 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980182
Page 127 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980183
Page 128 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980184
Page 129 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
1 Not Done Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980185
Page 130 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980186
Page 131 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980187
Page 132 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980188
Page 133 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980189
Page 134 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980190
Page 135 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980191
Page 136 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Feb/11/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980192
Page 137 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/16/2020Form: 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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980193
Page 138 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/16/2020Form: 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: 11161224 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:
Dec/16/2020
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 [BPTYYH]
5.bSample ID [BPTYYJ]
5.cSample ID [BPMF42]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980194
Page 139 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/10/2021Form: 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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980195
Page 140 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/10/2021Form: 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: 11161224 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:
Feb/10/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ015]
5.bSample ID [BRJ016]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980196
Page 141 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 - Unscheduled
Visit on Mar/09/2021Form: 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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C1
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980197
Page 142 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 - Unscheduled
Visit on Mar/09/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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:
Mar/9/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ07F]
5.bSample ID [BRJ07G]
5.cSample ID [ ]
5.dSample ID [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980198
Page 143 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980199
Page 144 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980200
Page 145 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980201
Page 146 of 840
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980202
Page 147 of 840
***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: 11161224 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:
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980203
Page 148 of 840
***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: 11161224 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 [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980204
Page 149 of 840
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yAE Identifie
rAdverse Even
tStart Dat
eIs the Adverse Event Still Ongoin
gForm Instance
1. DELETED Repeating Pages
2. DELETED Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980205
Page 150 of 840
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
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?:
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980206
Page 151 of 840
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980207
Page 152 of 840
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
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?
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980208
Page 153 of 840
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980209
Page 154 of 840
***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: 11161224 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 A
ctionForm Instance
1. Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980210
Page 155 of 840
***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: 11161224 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[ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980211
Page 156 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980212
Page 157 of 840
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980213
Page 158 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980214
Page 159 of 840
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980215
Page 160 of 840
***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: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980216
Page 161 of 840
***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: 11161224 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?
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980217
Page 162 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980218
Page 163 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980219
Page 164 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980220
Page 165 of 840
***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: 11161224 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:
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980221
Page 166 of 840
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980222
Page 167 of 840
***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: 11161224 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?
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980223
Page 168 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980224
Page 169 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980225
Page 170 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980226
Page 171 of 840
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980227
Page 172 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/24/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980228
Page 173 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980229
Page 174 of 840
***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: 11161224 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: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980230
Page 175 of 840
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980231
Page 176 of 840
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/3/2021
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980232
Page 177 of 840
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980233
Page 178 of 840
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/3/2021 Comments
2.Phase of Disposition: REPEAT SCREENING 1 Comments
3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980234
Page 179 of 840
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/3/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980235
Page 180 of 840
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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:
Mar/3/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ06H]
5.bSample ID [BRJ06J]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980236
Page 181 of 840
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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:
Mar/3/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ04N]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980237
Page 182 of 840
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/3/2021 15:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980238
Page 183 of 840
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980239
Page 184 of 840
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980240
Page 185 of 840
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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 [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980241
Page 186 of 840
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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?
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980242
Page 187 of 840
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980243
Page 188 of 840
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980244
Page 189 of 840
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980245
Page 190 of 840
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980246
Page 191 of 840
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980247
Page 192 of 840
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980248
Page 193 of 840
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980249
Page 194 of 840
***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: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/28/2020
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980250
Page 195 of 840
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980251
Page 196 of 840
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980252
Page 197 of 840
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-12-2020 13:49:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980253
Page 198 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormFeb-26-2021 15:29:02 (UTC-06:00) Central Time
(US & Canada)This illness visit is unrelated to the 2nd illness
visit that required hospitalization. There was no
hospitalization.
Not Applicable
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0980254
Page 199 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Feb-26-2021 15:29:02 (UTC-06:00) Central Time
(US & Canada)This illness visit is unrelated to the 2nd illness visit
that required hospitalization. There was no
hospitalization.
Not Applicable
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0980255
Page 200 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Feb-26-2021 15:29:02 (UTC-06:00) Central Time
(US & Canada)This illness visit is unrelated to the 2nd illness visit
that required hospitalization. There was no
hospitalization.
Not Applicable
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0980256
Page 201 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Feb-26-2021 15:29:02 (UTC-06:00) Central Time
(US & Canada)This illness visit is unrelated to the 2nd illness visit
that required hospitalization. There was no
hospitalization.
Not Applicable
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0980257
Page 202 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Feb-26-2021 15:29:02 (UTC-06:00) Central Time
(US & Canada)This illness visit is unrelated to the 2nd illness visit
that required hospitalization. There was no
hospitalization.
Not Applicable
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0980258
Page 203 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-17-2020 09:38:35 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980259
Page 204 of 840
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-17-2020 09:38:35 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980260
Page 205 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-17-2020 09:38:35 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980261
Page 206 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-17-2020 09:38:35 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980262
Page 207 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-17-2020 09:38:35 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980263
Page 208 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Nov-17-2020 09:38:35 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980264
Page 209 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Nov-17-2020 09:38:35 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980265
Page 210 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-17-2020 09:39:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980266
Page 211 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-17-2020 09:39:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980267
Page 212 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-17-2020 09:39:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980268
Page 213 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-17-2020 09:39:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980269
Page 214 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-17-2020 09:39:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980270
Page 215 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-17-2020 09:40:19 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980271
Page 216 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980272
Page 217 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980273
Page 218 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980274
Page 219 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980275
Page 220 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980276
Page 221 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980277
Page 222 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980278
Page 223 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980279
Page 224 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980280
Page 225 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980281
Page 226 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980282
Page 227 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980283
Page 228 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980284
Page 229 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980285
Page 230 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980286
Page 231 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980287
Page 232 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980288
Page 233 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980289
Page 234 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980290
Page 235 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980291
Page 236 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980292
Page 237 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980293
Page 238 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980294
Page 239 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980295
Page 240 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980296
Page 241 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980297
Page 242 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980298
Page 243 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980299
Page 244 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980300
Page 245 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980301
Page 246 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980302
Page 247 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-17-2020 09:40:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980303
Page 248 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-17-2020 09:40:44 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980304
Page 249 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980305
Page 250 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980306
Page 251 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980307
Page 252 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980308
Page 253 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980309
Page 254 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980310
Page 255 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980311
Page 256 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980312
Page 257 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980313
Page 258 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980314
Page 259 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980315
Page 260 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980316
Page 261 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980317
Page 262 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980318
Page 263 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980319
Page 264 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980320
Page 265 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980321
Page 266 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980322
Page 267 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980323
Page 268 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980324
Page 269 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980325
Page 270 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980326
Page 271 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980327
Page 272 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980328
Page 273 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980329
Page 274 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980330
Page 275 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980331
Page 276 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980332
Page 277 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980333
Page 278 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980334
Page 279 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980335
Page 280 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980336
Page 281 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980337
Page 282 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980338
Page 283 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980339
Page 284 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980340
Page 285 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980341
Page 286 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980342
Page 287 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980343
Page 288 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980344
Page 289 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980345
Page 290 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980346
Page 291 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980347
Page 292 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-17-2020 09:40:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980348
Page 293 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-17-2020 09:43:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980349
Page 294 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-17-2020 09:43:43 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980350
Page 295 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-17-2020 09:43:43 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980351
Page 296 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-17-2020 09:43:43 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980352
Page 297 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-17-2020 09:44:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f1d\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980353
Page 298 of 840
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161224 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDa
…[truncated]