125742 S1 M5 CRF c4591001 1114 11141075

Document text

Page 1 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792412
Page 2 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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
Aug/21/2020
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792413
Page 3 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11141075]
2.Birth Date: /1980
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:
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792414
Page 4 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792415
Page 5 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792416
Page 6 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792417
Page 7 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:[allergic to Intravenous iodine]
Start Date: UNK/UNK/2006
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic to latex]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic to scopolamine patch]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[myopia]
Start Date: UNK/UNK/1993
Ongoing: YES
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792418
Page 8 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:[seasonal allergies]
Start Date: Jun/UNK/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tinea versicolor]
Start Date: UNK/UNK/1994
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[water retention]
Start Date: Jan/UNK/2020
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792419
Page 9 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cholelithiasis]
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:[appendicitis]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[fallopian tube defect]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[neck pain]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792420
Page 10 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/2000
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2019
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[neck fusion]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterectomy]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792421
Page 11 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cholecystectomy]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendectomy]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792422
Page 12 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [99.7]
3.Unit: kg
4.Height: [167.5]
5.Unit: cm
6.Body Mass Index: [35.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792423
Page 13 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792424
Page 14 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [61498]
3.Randomization Group: [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792425
Page 15 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:
Aug/21/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5FRB]
5.bSample ID [BP5FRC]
5.cSample ID [BP5FRD]
5.dSample ID [BPR79V]
5.eSample ID [BPR79W]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792426
Page 16 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:
Aug/21/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5FPK]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792427
Page 17 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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: Aug/21/2020 17:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792428
Page 18 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792429
Page 19 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792430
Page 20 of 503
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792431
Page 21 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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/10/2020
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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792432
Page 22 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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/10/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5G0B]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792433
Page 23 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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/10/2020 14:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792434
Page 24 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792435
Page 25 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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/9/2020
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 [BPVPJG]
5.bSample ID [BPR6TZ]
5.cSample ID [BPR6V0]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792436
Page 26 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792437
Page 27 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/20/2020
2.Date of First Symptom Started: Oct/18/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/14/2020
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? YES
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? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4 hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792438
Page 28 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache ]
5.bSymptoms - Other Text: [Chest tightness ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792439
Page 29 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/17/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792440
Page 30 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/17/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT Unknown] Comments
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792441
Page 31 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792442
Page 32 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BP5G32]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792443
Page 33 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:YES
Number of Visits or Contacts:
[1]
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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792444
Page 34 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792445
Page 35 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.        Repeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792446
Page 36 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Hospitalization Details
1.Hospitalization Category:
2.Hospitalization Term:
3.Admission Date: //
4.Ongoing?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792447
Page 37 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792448
Page 38 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792449
Page 39 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:
Nov/17/2020
3.Toxicity Grade: 1
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792450
Page 40 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792451
Page 41 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792452
Page 42 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792453
Page 43 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792454
Page 44 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792455
Page 45 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792456
Page 46 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
 1.Oct/20/2020 Record Identifier: Systolic: Diastolic:
1  124  82 Repeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792457
Page 47 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [124]
Diastolic: [82]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [74]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792458
Page 48 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792459
Page 49 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792460
Page 50 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.      Repeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792461
Page 51 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792462
Page 52 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792463
Page 53 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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.Start Date: //
6.Ongoing?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792464
Page 54 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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.        Repeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792465
Page 55 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792466
Page 56 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792467
Page 57 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/4/2021
2.Date of First Symptom Started: Dec/28/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/16/2021
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? YES
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? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792468
Page 58 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Nasal Congestion]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792469
Page 59 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/5/202
1 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792470
Page 60 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/5/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [Reactive A] Comments
9.Trade Name Other, Specify: [NALT Unknown] Comments
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792471
Page 61 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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? YES
Date of Collection:
Jan/4/2021
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 [CV26631]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792472
Page 62 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:[Telehealth visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792473
Page 63 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:YES
Number of Visits or Contacts:
[1]
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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792474
Page 64 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792475
Page 65 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Hospitalization CategoryHospitalization Ter
mAdmission Dat
eOngoing Form Instance
 1.HOSPITALIZATION STATUS
 HOSPITAL   Jan/5/2021  NO
Discharge Date
:
Jan/13/2021
 Repeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792476
Page 66 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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: Jan/5/2021
4.Ongoing? NO
Discharge Date:
Jan/13/2021
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792477
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment I
dentifierCon Non-Drug Treatm
ents Pre-specifiedTreatment TreatmentStart
DateForm Instan
ce
 1.1  YES  HIGH FLOW OXYG
EN THERAPY HIGH FLOW OXYG
EN THERAPY Jan/5/2
021 Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792478
Page 68 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1] Comments
2.Concomitant Non-drug Treatment
Pre-specified:YES Comments
3.Treatment: HIGH FLOW OXYGEN THERAPY Comments
4.Treatment: [HIGH FLOW OXYGEN THERAPY] Comments
5.Start Date: Jan/5/2021 Comments
6.Ongoing? NO
End Date:
Jan/11/2021Comments
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792479
Page 69 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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 pneumonia]
Date of Diagnosis:
Jan/7/2021
3.Toxicity Grade: 1
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792480
Page 70 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792481
Page 71 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792482
Page 72 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category f
or Lab TestVendor NameCollect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
 1.CLINICAL
CHEMIST
RY Newton Medical Center
Laboratory 600 Medical
Center Dr.
Newton Kansas 67114 Jan/6/2
021 BLOO
D Sponsor-De
fined Ident
ifierTest:Res
ult:
329  C Reactive Pro
tein_PX329 54.
8 
30  Alanine Amin
otransferase_P
X30 59 
28  Aspartate Ami
notransferase_
PX28 64 
35  Alkaline Phos
phatase_PX35 95 
21  Bilirubin_PX2
1 0.4 
47  Blood Urea Ni
trogen_PX47 16 
48  Creatinine_PX
48 .8 Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0792483
Page 73 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Newton Medical Center Laboratory 600 Medical Center Dr.
Newton Kansas 67114]
3.Collection Date: Jan/6/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [54.8]
Not Done:
LNMT Low
[0]
High
[9]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [59]
Not Done:
LNMT Low
[1]
High
[35]
Unit
U/L
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792484
Page 74 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [64]
Not Done:
LNMT Low
[14]
High
[36]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [95]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.4]
Not Done:
LNMT Low
[.2]
High
[1.3]
Unit
mg/dL
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792485
Page 75 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [16]
Not Done:
LNMT Low
[7]
High
[17]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [.8]
Not Done:
LNMT Low
[.7]
High
[1.2]
Unit
mg/dL
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792486
Page 76 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category f
or Lab Tes
tVendor Name (DERIVED
)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.HEMATO
LOGY Newton Medical Center La
boratory 600 Medical Cent
er Dr.
Newton Kansas 67114 Jan/6/20
21 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1  Hemoglob
in_PX1 13.
9 
2  Hematocri
t_PX2 42.
4 
3  Erythrocyt
es_PX3 5.0
7 
5  Platelets_
PX5 239
 
7  Leukocyte
s_PX7 [ ] 
608  Neutrophil
s_PX608 4.5 
609  Eosinophil
s_PX609 0 
612  Monocyte
s_PX612 6 
610  Basophils
_PX610 0 
611  Lymphocy
tes_PX611
 0.8 Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792487
Page 77 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Newton Medical Center Laboratory 600 Medical Center Dr.
Newton Kansas 67114]
3.Collection Date: Jan/6/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.9]
Not Done:
LNMT Low
[12]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [42.4]
Not Done:
LNMT Low
[36]
High
[46]
Unit
%
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792488
Page 78 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.07]
Not Done:
LNMT Low
[4]
High
[5.2]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [239]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^6/cu mm
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792489
Page 79 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [4.5]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
10^6/cu mm
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0]
Not Done:
LNMT Low
[0]
High
[4]
Unit
%
5 hSponsor ID: [612]
Test: Monocytes_PX612
Result: [6]
Not Done:
LNMT Low
[0]
High
[9]
Unit
%
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792490
Page 80 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0]
Not Done:
LNMT Low
[0]
High
[2]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.8]
Not Done:
LNMT Low
[1]
High
[4.8]
Unit
10^6/cu mm
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792491
Page 81 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
 1.Jan/6/2021 Record Identifier: Systolic: Diastolic:
1  118  79 Repeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792492
Page 82 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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: Jan/6/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [118]
Diastolic: [79]
Respiratory Rate in
respirations/minute:[19]
Heart Rate in beats/minute: [93]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792493
Page 83 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
 1.Jan/5/2021 Record Identifier: Oxygen Saturation
1  86.0 Repeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792494
Page 84 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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: Jan/5/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [86.0]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792495
Page 85 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792496
Page 86 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792497
Page 87 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792498
Page 88 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792499
Page 89 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of
Assessm
entLocation
of Assess
mentImagin
g Meth
odOverall AssessmentForm Insta
nce
 1.Feb/5/20
21 CHEST  X-RAY  INDETERMINATE  Repeating
Pages
 2.Feb/7/20
21 CHEST  CT SC
AN ABNORMAL
If abnormal, specify findings:
Pulmonary findings consistent with COVID-19 pneumonia o
f moderate severity. Developing bacterial superinfection in th
e lower lobes cannot be excluded.
 Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792500
Page 90 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Feb/5/2021 Comments
2.Location of Assessment: CHEST Comments
3.Type of Imaging Exam: X-RAY Comments
4.Assessment: INDETERMINATE Comments
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792501
Page 91 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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: Feb/7/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Pulmonary findings consistent with COVID-19 pneumonia of moderate
severity. Developing bacterial superinfection in the lower lobes cannot be
excluded.]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792502
Page 92 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/23/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792503
Page 93 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BPR6ZW]
5.bSample ID [BPR6ZX]
5.cSample ID [BPVPLZ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792504
Page 94 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Feb/05/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792505
Page 95 of 503
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Feb/05/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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/5/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM3CKB]
5.bSample ID [BM3CKC]
5.cSample ID [BPVPRX]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792506
Page 96 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792507
Page 97 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792508
Page 98 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792509
Page 99 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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: [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792510
Page 100 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792511
Page 101 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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 [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792512
Page 102 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# CategoryAE Ident
ifierAdverse Eve
ntStart DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1. DELETED ADVERSE E
VENT 1  Covid-19 Illn
ess A Oct/18/2020
09:00 YES  Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792513
Page 103 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Covid-19 Illness A ]
4.Start Date Time: Oct/18/2020 09:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792514
Page 104 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Viral Infection ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792515
Page 105 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792516
Page 106 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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[ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792517
Page 107 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792518
Page 108 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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: //
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792519
Page 109 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1. DELETED           Repeating
Pages
 2. DELETED           Repeating
Pages
 3. DELETED           Repeating
Pages
 4. DELETED           Repeating
Pages
 5. DELETED           Repeating
Pages
 6. DELETED           Repeating
Pages
 7. DELETED           Repeating
Pages
 8. DELETED           Repeating
Pages
 9. DELETED           Repeating
Pages
 10. DELETED           Repeating
Pages
 11. DELETED           Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792520
Page 110 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792521
Page 111 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: Comments
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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792522
Page 112 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792523
Page 113 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: Comments
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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792524
Page 114 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: Comments
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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792525
Page 115 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: Comments
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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792526
Page 116 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: Comments
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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792527
Page 117 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: Comments
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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792528
Page 118 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: Comments
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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792529
Page 119 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: Comments
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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792530
Page 120 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: Comments
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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792531
Page 121 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792532
Page 122 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792533
Page 123 of 503
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792534
Page 124 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792535
Page 125 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792536
Page 126 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792537
Page 127 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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:
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792538
Page 128 of 503
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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?
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792539
Page 129 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792540
Page 130 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792541
Page 131 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792542
Page 132 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792543
Page 133 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792544
Page 134 of 503
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792545
Page 135 of 503
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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: [ ]
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792546
Page 136 of 503
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792547
Page 137 of 503
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792548
Page 138 of 503
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792549
Page 139 of 503
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
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(b) (4)
FDA-CBER-2021-5683-0792550
Page 140 of 503
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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/9/2020
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792551
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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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792552
Page 142 of 503
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 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
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792553
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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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-22-2020 12:19:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792554
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Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-22-2020 12:33:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable, subject surgically sterile
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792555
Page 145 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-22-2020 12:33:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable, subject surgically sterile
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792556
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-22-2020 12:33:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable, subject surgically sterile
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792557
Page 147 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-22-2020 12:33:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable, subject surgically sterile
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792558
Page 148 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Aug-22-2020 12:33:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable, subject surgically sterile
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792559
Page 149 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Aug-22-2020 12:33:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable, subject surgically sterile
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792560
Page 150 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aAug-22-2020 12:33:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable, subject surgically sterile
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792561
Page 151 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aAug-22-2020 12:33:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable, subject surgically sterile
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792562
Page 152 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aAug-22-2020 12:33:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable, subject surgically sterile
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792563
Page 153 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
FormOct-26-2020 08:23:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792564
Page 154 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
1Oct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792565
Page 155 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
2Oct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792566
Page 156 of 503
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
3Oct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792567
Page 157 of 503
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
4Oct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792568
Page 158 of 503
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Nov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
5Oct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792569
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Nov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
6Oct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792570
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Nov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
7Oct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792571
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Nov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
8Oct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792572
Page 162 of 503
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Nov-24-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)
9Oct-26-2020 08:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792573
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormOct-26-2020 08:24:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792574
Page 164 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Oct-26-2020 08:24:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792575
Page 165 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-26-2020 08:24:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792576
Page 166 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Oct-26-2020 08:24:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792577
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-26-2020 08:24:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792578
Page 168 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormFeb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
FormJan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792579
Page 169 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Feb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
1Jan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792580
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Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Feb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
2Jan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792581
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Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Feb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
3Jan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792582
Page 172 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Feb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
4Jan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792583
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Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Feb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
5Jan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792584
Page 174 of 503
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Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Feb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
6Jan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792585
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Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Feb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
7Jan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792586
Page 176 of 503
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Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Feb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
8Jan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792587
Page 177 of 503
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Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Feb-08-2021 15:39:48 (UTC-06:00) Central
Time (US & Canada)
9Jan-06-2021 08:23:22 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792588
Page 178 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormFeb-10-2021 08:29:59 (UTC-06:00) Central
Time (US & Canada)
FormFeb-08-2021 09:48:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
FormFeb-08-2021 09:48:27 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792589
Page 179 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Feb-10-2021 08:29:59 (UTC-06:00) Central
Time (US & Canada)
1Feb-08-2021 09:48:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
1Feb-08-2021 09:48:27 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792590
Page 180 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Feb-10-2021 08:29:59 (UTC-06:00) Central
Time (US & Canada)
2Feb-08-2021 09:48:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
2Feb-08-2021 09:48:27 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792591
Page 181 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Feb-10-2021 08:29:59 (UTC-06:00) Central
Time (US & Canada)
3Feb-08-2021 09:48:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
3Feb-08-2021 09:48:27 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792592
Page 182 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Feb-10-2021 08:29:59 (UTC-06:00) Central
Time (US & Canada)
4Feb-08-2021 09:48:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
4Feb-08-2021 09:48:27 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792593
Page 183 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Feb-10-2021 08:29:59 (UTC-06:00) Central
Time (US & Canada)
5Feb-08-2021 09:48:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
5Feb-08-2021 09:48:27 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792594
Page 184 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Feb-10-2021 08:29:59 (UTC-06:00) Central
Time (US & Canada)
6Feb-08-2021 09:48:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
6Feb-08-2021 09:48:27 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792595
Page 185 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormFeb-18-2021 08:19:09 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
FormFeb-16-2021 08:23:02 (UTC-06:00) Central
Time (US & Canada)
FormFeb-11-2021 14:28:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792596
Page 186 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Feb-18-2021 08:19:09 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
1Feb-16-2021 08:23:02 (UTC-06:00) Central
Time (US & Canada)
1Feb-11-2021 14:28:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792597
Page 187 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Feb-18-2021 08:19:09 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
2Feb-16-2021 08:23:02 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 14:28:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
2Feb-10-2021 08:28:57 (UTC-06:00) Central
Time (US & Canada)
2Feb-08-2021 16:35:53 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792598
Page 188 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Feb-18-2021 08:19:09 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
3Feb-16-2021 08:23:02 (UTC-06:00) Central
Time (US & Canada)
3Feb-11-2021 14:28:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792599
Page 189 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Feb-18-2021 08:19:09 (UTC-06:00) Central
Time (US & Canada)Not Done
Not Done
4Feb-16-2021 08:23:02 (UTC-06:00) Central
Time (US & Canada)
4Feb-11-2021 14:28:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792600
Page 190 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormFeb-08-2021 09:51:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792601
Page 191 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Feb-08-2021 09:51:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792602
Page 192 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Feb-08-2021 09:51:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792603
Page 193 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Feb-08-2021 09:51:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792604
Page 194 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormFeb-08-2021 09:51:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792605
Page 195 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Feb-08-2021 09:51:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792606
Page 196 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Feb-08-2021 09:51:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792607
Page 197 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Feb-08-2021 09:51:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792608
Page 198 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Feb-08-2021 09:51:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792609
Page 199 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Feb-08-2021 09:51:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792610
Page 200 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Feb-08-2021 09:51:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792611
Page 201 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormFeb-09-2021 14:23:06 (UTC-06:00) Central
Time (US & Canada)
FormFeb-08-2021 09:52:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792612
Page 202 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Feb-09-2021 14:23:06 (UTC-06:00) Central
Time (US & Canada)
1Feb-08-2021 09:52:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792613
Page 203 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Feb-09-2021 14:23:06 (UTC-06:00) Central
Time (US & Canada)
2Feb-08-2021 09:52:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792614
Page 204 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Feb-09-2021 14:23:06 (UTC-06:00) Central
Time (US & Canada)
3Feb-08-2021 09:52:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792615
Page 205 of 503
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Jan/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Feb-09-2021 14:23:06 (UTC-06:00) Central
Time (US & Canada)
4Feb-08-2021 09:52:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792616
Page 206 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormFeb-26-2021 16:20:10 (UTC-06:00) Central
Time (US & Canada)Medication given during COVID treatment
and recorded
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792617
Page 207 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormFeb-26-2021 16:21:08 (UTC-06:00) Central
Time (US & Canada)Medication given during COVID treatment
and recorded
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792618
Page 208 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Mar-04-2021 08:24:22 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 14:38:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792619
Page 209 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Mar-04-2021 08:37:27 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 14:41:51 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792620
Page 210 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Mar-04-2021 08:39:57 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 15:10:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792621
Page 211 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Mar-04-2021 08:44:37 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 15:12:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792622
Page 212 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Mar-04-2021 08:46:46 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 15:13:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792623
Page 213 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Mar-04-2021 08:53:55 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 15:35:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792624
Page 214 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Mar-04-2021 08:57:49 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 15:36:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792625
Page 215 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Mar-04-2021 09:00:20 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 17:19:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792626
Page 216 of 503
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Mar-04-2021 09:02:06 (UTC-06:00) Central
Time (US & Canada)
2Feb-11-2021 17:20:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0792627
Page 217 of 503
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Jan-28-2021 10:23:40 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard
Glover Approved Jan-25-2021 11:44:57 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardGlover, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-04-2020 14:45:27 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard
Glover Approved Dec-02-2020 13:41:50 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792628
Page 218 of 503
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, RichardGlover, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-24-2020 08:27:02 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard
Glover Approved Oct-26-2020 17:21:03 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardGlover, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-26-2020 08:21:40 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard
Glover Approved Oct-23-2020 10:08:49 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792629
Page 219 of 503
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, RichardGlover, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-21-2020 16:12:45 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard
Glover Approved Oct-21-2020 14:37:02 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardGlover, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792630
Page 220 of 503
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-22-2020 12:18:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-22-2020 12:18:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792631
Page 221 of 503
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-22-2020 12:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/21/2020Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792632
Page 222 of 503
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-22-2020 12:18:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11141075Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-22-2020 12:17:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1980Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-22-2020 12:18:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-22-2020 12:18:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-22-2020 12:18:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792633
Page 223 of 503
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-22-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/21/2020Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792634
Page 224 of 503
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-22-2020 12:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-22-2020 12:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-22-2020 12:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792635
Page 225 of 503
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Aug-22-2020 12:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:allergic to Intrav
enous iodine
Start Date: UNK/UNK/200
6
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
allergic to Intravenous iodineInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-22-2020 12:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2006Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792636
Page 226 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-22-2020 12:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-22-2020 12:22:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:allergic to la
tex
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792637
Page 227 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:22:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:22:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
allergic to latexInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-22-2020 12:22:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-22-2020 12:22:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-22-2020 12:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:allergic to scopo
lamine patch
Start Date: UNK/UNK/201
9
Ongoing: YESInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792638
Page 228 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
allergic to scopolamine patchInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-22-2020 12:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-22-2020 12:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-22-2020 12:23:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:myopia
Start Date: UNK/UNK/
1993
Ongoing: YESInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792639
Page 229 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.d Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:23:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:23:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
myopiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-22-2020 12:23:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1993Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-22-2020 12:23:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-22-2020 12:24:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:seasonal alle
rgies
Start Date: Jun/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792640
Page 230 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:24:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:24:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-22-2020 12:24:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-22-2020 12:24:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-22-2020 12:24:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:tinea versico
lor
Start Date: UNK/UNK/
1994
Ongoing: YESInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792641
Page 231 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.f Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:24:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:24:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
tinea versicolorInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-22-2020 12:24:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1994Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-22-2020 12:24:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-22-2020 12:24:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:hyperlipide
mia
Start Date: UNK/UNK/
2019
Ongoing: YESInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792642
Page 232 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.g Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:24:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:24:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hyperlipidemiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-22-2020 12:24:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-22-2020 12:24:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-22-2020 12:26:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:water retent
ion
Start Date: Jan/UNK/2
020
Ongoing: YESInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792643
Page 233 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.h Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:26:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:26:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
water retentionInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-22-2020 12:26:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-22-2020 12:26:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-22-2020 12:27:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:sleep apnea
Start Date: UNK/UNK/
2019
Ongoing: YESInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792644
Page 234 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.i Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:27:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:27:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
sleep apneaInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-22-2020 12:27:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-22-2020 12:27:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-22-2020 12:27:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:cholelithiasis
Start Date: UNK/UNK/20
17Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792645
Page 235 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
UNK/UNK
/2017
1.j Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:27:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:27:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cholelithiasisInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-22-2020 12:27:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-22-2020 12:27:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792646
Page 236 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.k
Date Location User Value Reason
Aug-22-2020 12:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:appendicitis
Start Date: UNK/UNK/20
17
Ongoing: NO
End Date:
UNK/UNK
/2017Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792647
Page 237 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.k Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
appendicitisInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-22-2020 12:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-22-2020 12:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.l
Date Location User Value Reason
Aug-22-2020 12:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:12
Medical Histor
y Term:fallopian tube
defectInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792648
Page 238 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Start Date: UNK/UNK/20
07
Ongoing: NO
End Date:
UNK/UNK
/2007
1.l Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
fallopian tube defectInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-22-2020 12:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-22-2020 12:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.m
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792649
Page 239 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-24-2020 11:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:13
Medical Histor
y Term:neck pain
Start Date: UNK/UNK
/2019
Ongoing: YESChanged
Information
Aug-22-2020 12:29:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:13
Medical Histo
ry Term:neck pain
Start Date: UNK/UNK/2
019
Ongoing: NO
End Date:
UNK/UN
K/2019Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792650
Page 240 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.m Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:29:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:29:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
neck painInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-22-2020 12:29:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-24-2020 11:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESChanged
Information
Aug-22-2020 12:29:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.n
Date Location User Value Reason
Aug-22-2020 12:29:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:14Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792651
Page 241 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical History
Term:anxiety
Start Date: UNK/UNK/
2000
Ongoing: YES
1.n Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:29:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:29:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
anxietyInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-22-2020 12:29:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-22-2020 12:29:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Aug-22-2020 12:30:03
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb 15Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792652
Page 242 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) er:
Medical History
Term:depression
Start Date: UNK/UNK/
2019
Ongoing: YES
1.o Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:30:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:30:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
depressionInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-22-2020 12:30:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-22-2020 12:30:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792653
Page 243 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-22-2020 12:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:16
Medical Histor
y Term:neck fusion
Start Date: UNK/UNK/20
19
Ongoing: NO
End Date:
UNK/UNK
/2019Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792654
Page 244 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.p Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
neck fusionInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-22-2020 12:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-22-2020 12:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.q
Date Location User Value Reason
Aug-22-2020 12:31:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:17
Medical Histor
y Term:hysterectomyInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792655
Page 245 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Start Date: UNK/UNK/20
07
Ongoing: NO
End Date:
UNK/UNK
/2007
1.q Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:31:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:31:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hysterectomyInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-22-2020 12:31:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-22-2020 12:31:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.r
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792656
Page 246 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-22-2020 12:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:18
Medical Histor
y Term:cholecystecto
my
Start Date: UNK/UNK/20
17
Ongoing: NO
End Date:
UNK/UNK
/2017Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792657
Page 247 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.r Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cholecystectomyInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-22-2020 12:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-22-2020 12:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.s
Date Location User Value Reason
Aug-22-2020 12:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:19
Medical Histor
y Term:appendectomyInitial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792658
Page 248 of 503
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Start Date: UNK/UNK/20
17
Ongoing: NO
End Date:
UNK/UNK
/2017
1.s Line/MH Number:
Date Location User Value Reason
Aug-22-2020 12:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 12:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
appendectomyInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-22-2020 12:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.s Ongoing:
Date Location User Value Reason
Aug-22-2020 12:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792659
Page 249 of 503
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Aug-22-2020 12:32:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-22-2020 12:32:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
99.7Initial Entry
3. Unit:
Date Location User Value Reason
Aug-22-2020 12:32:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-22-2020 12:32:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
167.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-22-2020 12:32:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3d52\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792660
Page 250 of 503
***Confid
…[truncated]