Document text
Page 1 of 205
***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: 11141080 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
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792915
Page 2 of 205
***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: 11141080 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/24/2020
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792916
Page 3 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11141080]
2.Birth Date: /1959
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792917
Page 4 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792918
Page 5 of 205
***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: 11141080 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
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792919
Page 6 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792920
Page 7 of 205
***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: 11141080 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:[Type 2 Diabetes Mellitus]
Start Date: Jan/1/1986
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Trauma Left Leg]
Start Date: Jan/1/2005
Ongoing: NO
End Date:
Jan/1/2018
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Trama Right Leg]
Start Date: Jan/1/2005
Ongoing: NO
End Date:
Nov/1/2012
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: Jan/1/2010
Ongoing: YES
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792921
Page 8 of 205
***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: 11141080 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:[Amputed Left Leg]
Start Date: Jan/1/2018
Ongoing: NO
End Date:
Jan/1/2018
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Amputed Right Leg]
Start Date: Nov/1/2012
Ongoing: NO
End Date:
Nov/1/2012
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Nov/3/2017
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: Nov/14/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: Oct/UNK/2015
Ongoing: YES
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792922
Page 9 of 205
***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: 11141080 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:[Depression]
Start Date: Jan/1/2013
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Neuropathy]
Start Date: Jan/UNK/1986
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent Methicillin-resistant Staphylococcus aureus Infections]
Start Date: Jan/UNK/2017
Ongoing: YES
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792923
Page 10 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [127.7]
3.Unit: kg
4.Height: [185.5]
5.Unit: cm
6.Body Mass Index: [37.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792924
Page 11 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [238246]
3.Randomization Group: [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792925
Page 12 of 205
***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: 11141080 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/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5FS8]
5.bSample ID [BP5FS9]
5.cSample ID [BP5FSB]
5.dSample ID [BPR7B5]
5.eSample ID [BPR7B6]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792926
Page 13 of 205
***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: 11141080 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/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5FRL]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792927
Page 14 of 205
***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: 11141080 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/24/2020 15:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792928
Page 15 of 205
***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: 11141080 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
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792929
Page 16 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792930
Page 17 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792931
Page 18 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5G2W]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792932
Page 19 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/30/2020 09:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792933
Page 20 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792934
Page 21 of 205
***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: 11141080 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/29/2020
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 [BPVPLN]
5.bSample ID [BPR6Z9]
5.cSample ID [BPR6ZB]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792935
Page 22 of 205
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792936
Page 23 of 205
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 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 [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792937
Page 24 of 205
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792938
Page 25 of 205
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 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 [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792939
Page 26 of 205
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792940
Page 27 of 205
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 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 [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792941
Page 28 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792942
Page 29 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792943
Page 30 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 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 [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792944
Page 31 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 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 [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792945
Page 32 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792946
Page 33 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792947
Page 34 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792948
Page 35 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 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 [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792949
Page 36 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792950
Page 37 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792951
Page 38 of 205
***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: 11141080 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/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792952
Page 39 of 205
***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: 11141080 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: [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792953
Page 40 of 205
***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: 11141080 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:
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792954
Page 41 of 205
***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: 11141080 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 [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792955
Page 42 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 MRSA infection Right
Stump Sep/12/2020 08:00
NO
End Date Time:
Oct/8/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Atrial fibrillation Sep/14/2020 10:00
YES Repeating
Pages
3.ADVERSE EV
ENT 3 chest pain Sep/14/2020 10:00
NO
End Date Time:
Sep/14/2020 11:00
Repeating
Pages
4.ADVERSE EV
ENT 4 Pulmonary Hypertensi
on Sep/14/2020 10:00
YES Repeating
Pages
5.ADVERSE EV
ENT 5 Left Ventricular Hyper
trophy Sep/14/2020 10:00
YES Repeating
Pages
6.ADVERSE EV
ENT 6 mitral valve regurgitat
ion Sep/14/2020 10:00
YES Repeating
Pages
7.ADVERSE EV
ENT 7 Tricuspid regurgitatio
n Sep/14/2020 10:00
YES Repeating
Pages
8.ADVERSE EV
ENT 8 acute kidney injury Sep/12/2020 UNK
:UNK NO
End Date Time:
Nov/2/2020 UNK:UNK
Repeating
Pages
9.ADVERSE EV
ENT 9 skin avulsion, left fing
er Sep/12/2020 UNK
:UNK NO
End Date Time:
Sep/12/2020 UNK:UNK
Repeating
Pages
10.ADVERSE EV
ENT 10 bilateral hand pain Sep/12/2020 UNK
:UNK NO
End Date Time:
Sep/13/2020 UNK:UNK
Repeating
Pages
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792956
Page 43 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[MRSA infection Right Stump]
4.Start Date Time: Sep/12/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/8/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[Infection]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792957
Page 44 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020355554]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792958
Page 45 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Atrial fibrillation]
4.Start Date Time: Sep/14/2020 10:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Hypertension]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792959
Page 46 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792960
Page 47 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chest pain]
4.Start Date Time: Sep/14/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/14/2020 11:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Hypertension]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792961
Page 48 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792962
Page 49 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pulmonary Hypertension]
4.Start Date Time: Sep/14/2020 10:00
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
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:
[hypertension]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792963
Page 50 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792964
Page 51 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left Ventricular Hypertrophy]
4.Start Date Time: Sep/14/2020 10:00
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
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:
[hypertension]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792965
Page 52 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792966
Page 53 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[mitral valve regurgitation]
4.Start Date Time: Sep/14/2020 10:00
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
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:
[hypertension]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792967
Page 54 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792968
Page 55 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Tricuspid regurgitation]
4.Start Date Time: Sep/14/2020 10:00
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
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:
[Hypertension]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792969
Page 56 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792970
Page 57 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[acute kidney injury]
4.Start Date Time: Sep/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/2/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[MRSA infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792971
Page 58 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792972
Page 59 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[skin avulsion, left finger]
4.Start Date Time: Sep/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/12/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Musculoskeletal]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792973
Page 60 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792974
Page 61 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[bilateral hand pain]
4.Start Date Time: Sep/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/13/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Musculoskeletal]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792975
Page 62 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792976
Page 63 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792977
Page 64 of 205
***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: 11141080 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[ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792978
Page 65 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart Dat
eForm Instanc
e
1.1 VACCINATIONS NO Influenza Vacci
ne Sep/23/20
20 Repeating
Pages
2.2 VACCINATIONS NO Pneumonia vac
cine Aug/26/2
020 Repeating
Pages
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792979
Page 66 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Influenza Vaccine]
5.Date: Sep/23/2020
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792980
Page 67 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Pneumonia vaccine]
5.Date: Aug/26/2020
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792981
Page 68 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792982
Page 69 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792983
Page 70 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792984
Page 71 of 205
***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: 11141080 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?
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792985
Page 72 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792986
Page 73 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792987
Page 74 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792988
Page 75 of 205
***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: 11141080 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:
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792989
Page 76 of 205
***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: 11141080 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?
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792990
Page 77 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792991
Page 78 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792992
Page 79 of 205
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792993
Page 80 of 205
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792994
Page 81 of 205
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 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 [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792995
Page 82 of 205
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 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 [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792996
Page 83 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792997
Page 84 of 205
***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: 11141080 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792998
Page 85 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/26/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792999
Page 86 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793000
Page 87 of 205
***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: 11141080 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: [ ]
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793001
Page 88 of 205
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 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/29/2020
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793002
Page 89 of 205
***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: 11141080 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
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793003
Page 90 of 205
***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: 11141080 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
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793004
Page 91 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-25-2020 07:35:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0793005
Page 92 of 205
***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: 11141080 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 Feb-01-2021 10:36:53 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Glover Approved Nov-06-2020 12:13:35 (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.
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793006
Page 93 of 205
***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: 11141080 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-25-2020 07:34:34
(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-25-2020 07:34:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793007
Page 94 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 07:34:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/24/2020Initial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793008
Page 95 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020 07:34:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11141080Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020 07:34:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1959Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020 07:35:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 07:35:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020 07:35:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d51\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-2021-5683-0793009
Page 96 of 205
***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: 11141080 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-25-2020 07:35:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793010
Page 97 of 205
***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: 11141080 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-25-2020 07:35:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 07:35:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020 07:35:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793011
Page 98 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 07:41:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Type 2 Diabetes
Mellitus
Start Date: Jan/1/1986
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 07:41:22
(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-25-2020 07:41:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type 2 Diabetes MellitusInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 07:41:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/1986Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020 07:41:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3d51\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-2021-5683-0793012
Page 99 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-25-2020 07:42:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Trauma Left L
eg
Start Date: Jan/1/2005
Ongoing: NO
End Date:
Jan/1/2018Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020 07:42:23
(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-25-2020 07:42:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Trauma Left LegInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020 07:42:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020 07:42:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/1/2018Initial Entry
1.c
Date Location User Value Reason
090177e196ae3d51\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-2021-5683-0793013
Page 100 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-26-2020 13:52:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number
:3
Medical History T
erm:Trama Right
Leg
Start Date: Jan/1/2005
Ongoing: NO
End Date:
Nov/1/201
2Changed
Information
Aug-25-2020 07:43:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Trama Right
Leg
Start Date: Jan/1/2005
Ongoing: NO
End Date:
Jan/1/2012Initial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793014
Page 101 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020 07:43:15
(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-25-2020 07:43:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Trama Right LegInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020 07:43:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-26-2020 15:05:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-26-2020 13:52:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Aug-26-2020 13:52:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/1/2012Changed Information
Aug-26-2020 11:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN -
TRAUMA RIGHT
LEG reports END
date of 01 Jan 12.
However,
AMPUTATION of
this leg is entered as
01 Nov 12. Please
090177e196ae3d51\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-2021-5683-0793015
Page 102 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
review dates and
reconcile as
appropriate.
Aug-25-2020 07:43:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/1/2012Initial Entry
1.d
Date Location User Value Reason
Aug-25-2020 07:43:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term: Anxiety
Start Date: Jan/1/2010
Ongoing: YESInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793016
Page 103 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.d Line/MH Number:
Date Location User Value Reason
Aug-25-2020 07:43:43
(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-25-2020 07:43:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020 07:43:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-25-2020 07:43:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-25-2020 07:44:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:Amputed Left
Leg
Start Date: Jan/1/2018
Ongoing: NO
End Date:
Jan/1/2018Initial Entry
090177e196ae3d51\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-2021-5683-0793017
Page 104 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
Date Location User Value Reason
Aug-25-2020 07:44:19
(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-25-2020 07:44:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Amputed Left LegInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-25-2020 07:44:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-25-2020 07:44:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/1/2018Initial Entry
1.f
Date Location User Value Reason
Aug-25-2020 07:45:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Amputed Right
Leg
Start Date: Nov/1/2012
Ongoing: NO
End Date:
Nov/1/2012Initial Entry
090177e196ae3d51\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-2021-5683-0793018
Page 105 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.f Line/MH Number:
Date Location User Value Reason
Aug-25-2020 07:45:31
(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-25-2020 07:45:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Amputed Right LegInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-25-2020 07:45:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/1/2012Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-25-2020 07:45:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/1/2012Initial Entry
1.g
Date Location User Value Reason
Oct-13-2020 14:38:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Hypertensio
n
Start Date: Nov/3/2017
Ongoing: YESInitial Entry
090177e196ae3d51\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-2021-5683-0793019
Page 106 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.g Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:38:54
(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
Oct-13-2020 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-13-2020 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/3/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-13-2020 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-13-2020 14:39:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:Hyperlipidem
ia
Start Date: Nov/14/2018
Ongoing: YESInitial Entry
090177e196ae3d51\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-2021-5683-0793020
Page 107 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.h Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:39:27
(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
Oct-13-2020 14:39:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-13-2020 14:39:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/14/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-13-2020 14:39:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-13-2020 14:42:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Ter
m:Asthma
Start Date: Oct/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae3d51\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-2021-5683-0793021
Page 108 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.i Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:42:53
(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
Oct-16-2020 12:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Oct-15-2020 14:47:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject is not
receiving Systemic
corticosteroids
Oct-14-2020 14:25:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: The
subject presents at
screening with
ongoing asthma.
Please confirm that
participant is or is
not currently
receiving/plans to
receive systemic
corticosteroids with
the exception of
Inhaled Steroids due
to this condition.
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0793022
Page 109 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 14:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-13-2020 14:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-13-2020 14:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Oct-13-2020 14:46:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 10
Medical History Ter
m:Depressio
n
Start Date: Jan/1/201
3
Ongoing: YESTranscription Error
Oct-13-2020 14:43:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Ter
m:depressio
n
Start Date: Jan/1/201
3
Ongoing: YESInitial Entry
090177e196ae3d51\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-2021-5683-0793023
Page 110 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.j Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:43:57
(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
Oct-13-2020 14:46:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DepressionTranscription Error
Oct-13-2020 14:43:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
depressionInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-13-2020 14:43:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2013Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-13-2020 14:43:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Oct-13-2020 14:45:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Ter
m:Neuropathy
Start Date: Jan/UNK/19
86
Ongoing: YESInitial Entry
090177e196ae3d51\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-2021-5683-0793024
Page 111 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.k Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:45:57
(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
Oct-13-2020 14:45:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NeuropathyInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-13-2020 14:45:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/1986Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-13-2020 14:45:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Oct-13-2020 14:47:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:12
Medical
History T
erm:Recurrent Methicillin-re
sistant Staphylococcus a
ureus Infections
Start Dat
e:Jan/UNK/2017
Ongoing: YESInitial Entry
090177e196ae3d51\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-2021-5683-0793025
Page 112 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.l Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:47:47
(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
Oct-13-2020 14:47:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Recurrent Methicillin-resistant Sta
phylococcus aureus InfectionsInitial Entry
1.l Start Date:
Date Location User Value Reason
Oct-13-2020 14:47:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2017Initial Entry
1.l Ongoing:
Date Location User Value Reason
Oct-13-2020 14:47:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d51\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-2021-5683-0793026
Page 113 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
127.7Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
185.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
37.1Initial Entry
090177e196ae3d51\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-2021-5683-0793027
Page 114 of 205
***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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.a
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 07:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d51\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-2021-5683-0793028
Page 115 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - 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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020 07:38:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 07:38:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
238246Initial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793029
Page 116 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 07:46:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 07:46:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 07:46:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 07:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 07:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 07:46:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FS8Initial Entry
5.a Sample ID
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793030
Page 117 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-25-2020 07:46:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FS8Initial Entry
5.b
Date Location User Value Reason
Aug-25-2020 07:47:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FS9Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020 07:47:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FS9Initial Entry
5.c
Date Location User Value Reason
Aug-25-2020 07:47:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FSBInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-25-2020 07:47:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FSBInitial Entry
5.d
Date Location User Value Reason
Aug-25-2020 07:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR7B5Initial Entry
090177e196ae3d51\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793031
Page 118 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Aug-25-2020 07:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR7B5Initial Entry
5.e
Date Location User Value Reason
Aug-25-2020 07:47:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR7B6Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-25-2020 07:47:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR7B6Initial Entry
090177e196ae3d51\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-2021-5683-0793032
Page 119 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 07:48:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 07:48:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 07:48:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 07:48:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 07:48:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 07:48:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FRLInitial Entry
5.a Sample ID
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793033
Page 120 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-25-2020 07:48:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FRLInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793034
Page 121 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020 07:40:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 07:40:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 07:40:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 07:40:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 15:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 07:40:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-25-2020 07:40:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d51\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-2021-5683-0793035
Page 122 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7. Route:
Date Location User Value Reason
Aug-25-2020 07:40:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020 07:40:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-25-2020 07:40:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793036
Page 123 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020 07:40:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793037
Page 124 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020 04:43:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed As per site
confirmation -
updated PD tracker
Oct-02-2020 11:41:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject's was
hospitalized. Visit
was 14 days OOW
and PD was written.
Oct-01-2020 05:25:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-01-2020 03:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: DOV at this
visit is out of
window (14 day)
from DOV (24/Aug
/2020) at
V1D1VX1L. Please
either update DOV
or confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Sep-30-2020 10:20:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Sep-30-2020 10:20:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
Sep-29-2020 06:00:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Thank you for
confirming. Please
respond to query
only once updates
are made.
Sep-28-2020 18:03:59 ACV0PFEINFP6000 Query 1: Answered Subject was
090177e196ae3d51\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), (b)
(6)
(b) (4), (b)
6)
(b) (4)
FDA-CBER-2021-5683-0793038
Page 125 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)admitted to hospital
the day before this
visit was to occur.
Details of SAE have
been reported
Sep-26-2020 05:04:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thank you for
the response.
However, Kindly
review and complete
‘Date of Visit, Nasal
Swab, Vaccination,
Vital Signs' forms at
this visit. Thank you
Sep-25-2020 12:11:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject was
admitted to hospital
the day before this
visit was to occur.
Details of SAE have
been reported [AE
Log Entry #1].
Sep-25-2020 07:57:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal Swab,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
090177e196ae3d51\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-2021-5683-0793039
Page 126 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020 10:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020 10:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 37.4
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020 10:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-30-2020 10:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
37.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020 10:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3d51\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-2021-5683-0793040
Page 127 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-30-2020 10:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793041
Page 128 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020 10:59:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 10:59:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020 10:59:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-30-2020 10:59:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-30-2020 10:59:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020 10:59:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5G2WInitial Entry
5.a Sample ID
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793042
Page 129 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-30-2020 10:59:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP5G2WInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793043
Page 130 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-30-2020 10:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020 10:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020 10:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-30-2020 10:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020 09:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020 10:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-30-2020 10:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d51\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-2021-5683-0793044
Page 131 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7. Route:
Date Location User Value Reason
Sep-30-2020 10:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-30-2020 10:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-30-2020 10:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793045
Page 132 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020 09:10:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793046
Page 133 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 09:11:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 09:11:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020
19:41:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2
: ClosedAuto closed by
Validation Check:
VC_BEETRK001_03
Nov-02-2020
16:45:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2
: Answe
redTranscription Error
Nov-02-2020
16:45:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
YES
Date o
f Colle
ction:
Oct/2
9/20
20Transcription Error
Nov-02-2020 ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2 DMW5250518;Date
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0793047
Page 134 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13:45:50
(UTC-06:00)
Central Time
(US &
Canada): Opene
dof Collection is not
equal to Date of Visit.
Please clarify or
correct.
Nov-02-2020
09:12:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Delete
dClose Auto Query
Nov-02-2020
09:11:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Candid
ate'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Nov-02-2020
09:11:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
YES
Date o
f Colle
ction:
Oct/3
0/20
20Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 09:12:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVPLNInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 09:12:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPVPLNInitial Entry
5.b
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0793048
Page 135 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Nov-02-2020 09:14:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR6Z9Transcription Error
Nov-02-2020 09:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR6ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-02-2020 09:14:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-02-2020 09:14:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR6Z9Transcription Error
Nov-02-2020 09:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as
appropriate.
Nov-02-2020 09:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR6ZInitial Entry
5.c
Date Location User Value Reason
Nov-02-2020 09:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR6ZBInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-02-2020 09:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPR6ZBInitial Entry
090177e196ae3d51\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793049
Page 136 of 205
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
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: 11141080 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
Nov-04-2020 03:54:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-03-2020 08:12:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-03-2020 08:12:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020Transcription Error
Nov-03-2020 05:39:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Balaji
Prabu RQuery 1: Opened As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the 1-month
post vaccination visit
after the 2nd
vaccination. Please
complete treatment
disposition CRF and
update date of EOT
to match the date of
Visit 3.
Nov-02-2020 11:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-02-2020 11:02:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0793050
Page 137 of 205
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-02-2020 11:02:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793051
Page 138 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793052
Page 139 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793053
Page 140 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793054
Page 141 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793055
Page 142 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793056
Page 143 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793057
Page 144 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793058
Page 145 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-13-2020 15:07:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793059
Page 146 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-13-2020 15:09:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793060
Page 147 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-13-2020 15:10:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793061
Page 148 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Oct-19-2020
14:42:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
2: Clo
sedDiscrepancy has been
closed.
Oct-13-2020
15:11:53
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dOriginal value is
correct
Oct-13-2020
15:00:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dIf not reporting
amputation, please
update the term to
only reflect the
infection and not
anatomical location
for coding purposes.
Oct-13-2020
12:20:40
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Query
2: An
swere
dFU #3 was submitted.
Amputation was
previous medical
history.
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0793062
Page 149 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Canada)
Oct-13-2020
05:49:38
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
2: Op
enedMultiple actions for
MRSA INFECTION
RIGHT STUMP: Are
you reporting MRSA
INFECTION RIGHT
AMPUTATION
STUMP? If so, edit
and split the term into
MRSA INFECTION
and INFECTION
RIGHT
AMPUTATION
STUMP and submit
separately. Otherwise
clarify and update the
term as appropriate.
Thank you.
Oct-12-2020
20:36:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies
query
Oct-12-2020
17:42:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
1: An
swere
dChanged Information
Oct-12-2020
17:42:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
MRS
A infe
ction
Right
StumpChanged Information
Oct-09-2020
06:33:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedSAE RECON:
AER#2020355554,the
term was updated to
MRSA infection R
stump' in Safety
database while
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0793063
Page 150 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
retained as 'Cellulitis
Right Stump' in AE
CRF. Please confirm
correct term.If safety
update is required,
please submit a
follow-up form.
Sep-14-2020
16:20:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Cellul
itis Ri
ght St
umpInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 22:54:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-28-2020 09:02:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-28-2020 09:02:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020 08:00Transcription Error
Oct-27-2020 20:37:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 3:Per PSSR
confirmation,the onset
date indicated in the
follow up form sent was
12Sep2020.If the correct
onset date is
12Sep2020,the AE CRF
should be
updated.Otherwise,another
follow up AEM form
should be submitted to
clearly indicate
13Sep2020
Oct-27-2020 01:14:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate SAE RECON: To check
latest SAE listing
090177e196ae3d51\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-2021-5683-0793064
Page 151 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-26-2020 15:30:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered FU #5 sent.
Oct-24-2020 08:54:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 2: A follow
up SAE form is required
to update onset date in
Safety database. If correct
onset date is 13Sep2020,
please submit a follow-up
SAE for to correct onset
date.
Oct-23-2020 08:08:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject was seen in the
ER on 12Sep2020.
Subject was then seen
again in the ER
13Sep2020 and admitted
Oct-23-2020 05:26:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 2:In the
latest SAE listing onset
date is still 11Sep2020.
Per narrative of the case
'onset date updated from
"13Sep2020" to
"11Sep2020'. If correct
onset date is 13Sep2020
per previous query
response, please submit a
follow-up SAE form.
Oct-21-2020 22:53:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate SAE RECON: To check
next SAE listing
Oct-21-2020 09:05:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Onset date 13Sep2020
Oct-21-2020 00:09:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1: Please
confirm if follow up AEM
form was submitted to
update the onset date in
Safety database.
Oct-20-2020 13:53:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject was seen in the
ER on 12Sep2020.
Subject was then seen
again in the ER
13Sep2020 and admitted.
090177e196ae3d51\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),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793065
Page 152 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-20-2020 04:04:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020355554
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/13/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-21-2020 08:00:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/8/2020 UNK:UNKTranscription Error
Oct-05-2020 12:03:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-05-2020 11:49:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Confirming, event is
ongoing as of last
contact with subject.
Oct-01-2020 15:23:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
Please verify if
Cellulitis Right
Stump is truly
ongoing, then update
the END DATE and
OUTCOME as
appropriate.
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3d51\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),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793066
Page 153 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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).
Date Location User Value Reason
Sep-15-2020 05:13:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Cellulitis
Right Stump:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NO
Is this serious event life threateni
ng?
NOInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793067
Page 154 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Other medically important seriou
s event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-14-2020 16:21:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
InfectionNew Information
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d51\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-2021-5683-0793068
Page 155 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-21-2020
22:52:21
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-21-2020
08:00:12
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-21-2020
07:54:17
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE MRSA infection Right
Stump: Response to "What was the
outcome of this adverse event?" is 3
but End Date/Time is missing.
Oct-21-2020
07:54:17
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-21-2020
07:54:17
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOL
VEDTranscription Error
Oct-21-2020
00:08:16
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Reissued:Ope
nedSAE RECON 1: Per query response
'AE was resolved 08OCT2020'.
However, outcome is still recorded
as NOT RECOVERED/NOT
RESOLVED. Please confirm if this
should be updated to
RECOVERED/RESOLVED.
090177e196ae3d51\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-2021-5683-0793069
Page 156 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-20-2020
13:54:44
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered AE was resolved 08OCT2020
Oct-20-2020
04:04:53
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020355554,outcome
was reported as
RECOVERED/RESOLVED to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793070
Page 157 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-14-2020 16:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-16-2020 05:57:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed corrected SAE
number
Sep-16-2020 05:56:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020355554corrected SAE
number
Sep-15-2020 09:13:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered The subject is
currently in the
hospital. Additional
information will be
obtained upon
discharge.
Sep-15-2020 08:44:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL SAE
#2020354694 is for
subject 1231-2982;
please review for
subject 1231-1080
cellulitis AE if SAE
# would be
2020355554
Sep-15-2020 05:13:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020354694Initial Entry
090177e196ae3d51\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),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793071
Page 158 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020 18:30:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Oct-23-2020 16:36:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered No further update
Oct-23-2020 14:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Thank you
for the SAE update.
ECG on 14Sep20
reports Atrial flutter,
rate 95, PVCs.
Please review event
for A Fib, A Flutter,
A Fib Flutter or
other term. If
updated, please
submit a SAE safety
update.
Oct-23-2020 14:18:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed did not go through
Oct-20-2020 13:55:41
(UTC-06:00) CentralACV0PFEINFP6000 Query 2: Answered FU submitted
10/20/2020
090177e196ae3d51\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-2021-5683-0793072
Page 159 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
Oct-19-2020 13:50:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL Onset
date for new
condition Atrial
Fibrillation is 14 Sep
2020; during
hospitalization for
MRSA infection
(SAE 2020355554).
Please submit ECG
information and any
other assessment
such as ECHO (in
view of valve issues)
as a SAE safety
update
Oct-16-2020 13:23:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Oct-15-2020 14:38:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Does not meet
serious criteria
Oct-14-2020 13:32:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: can you
please confirm Atrial
fibrillation meets or
doesn't meet any of
the serious criteria
outlined in the
protocol section
10.3.2 and update
eCRF, if appropriate.
Thanks
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Atrial fibrillationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 10:00Initial Entry
090177e196ae3d51\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) (4)
(b) (4)
FDA-CBER-2021-5683-0793073
Page 160 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 13:30:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-22-2021 12:01:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered AE is still ongoing
Feb-19-2021 09:56:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY -
ATRIAL
FIBRILLATION
(reported as related
to HTN) with Start
Date of 14 Sep 20, is
still indicated as
ONGOING. Please
review and if an
END date is known,
please update.
Nov-11-2020 09:12:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:08:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE still ongoing
Nov-10-2020 11:20:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
Please verify if AE is
still ongoing, or
update with END
DATE and
OUTCOME as
applicable.
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae3d51\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),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0793074
Page 161 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
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).
Date Location User Value Reason
Oct-28-2020 23:04:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Oct-28-2020 10:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SAE FU form was
sent indicating that
No COVID test was
done
Oct-27-2020 23:17:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical - yes, no
hospital COVID test
was documented;
please submit this
pertinent negative
information in a SAE
safety followup
Oct-27-2020 12:18:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered No Covid test was
documented in
medical records.
Oct-26-2020 18:31:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical – Thank
you. If NO hospital
Covid test was
performed is known,
please submit this
information on a
follow-up SAE form,
as pertinent
information for this
trial.
Oct-23-2020 16:39:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered No
090177e196ae3d51\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),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0793075
Page 162 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-23-2020 14:21:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020355554] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
HypertensionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3d51\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-2021-5683-0793076
Page 163 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 14:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d51\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-2021-5683-0793077
Page 164 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
chest painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/14/2020 11:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d51\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-2021-5683-0793078
Page 165 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
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).
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
HypertensionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3d51\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-2021-5683-0793079
Page 166 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 15:00:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d51\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-2021-5683-0793080
Page 167 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020 18:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for SAE
followup with Pulm
HTN info
Oct-20-2020 13:55:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered FU submitted
10/20/2020
Oct-19-2020 13:52:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL Onset
date for new
condition Pulmonary
Hypertension is 14
Sep 2020; during
hospitalization for
MRSA infection
(SAE 2020355554).
Please submit
assessment
procedures
documenting this
diagnosis as a SAE
safety update
Oct-13-2020 15:02:24
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Pulmonary HypertensionInitial Entry
090177e196ae3d51\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-2021-5683-0793081
Page 168 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 13:31:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-22-2021 12:02:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered AE still ongoing
Feb-19-2021 09:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY -
PULMONARY HTN
(reported as related
to HTN) with Start
Date of 14 Sep 20, is
still indicated as
ONGOING. Please
review and if an
END date is known,
please update.
Nov-11-2020 09:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE still ongoing
Nov-10-2020 11:21:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
Please verify if AE is
still ongoing, or
update with END
DATE and
OUTCOME as
applicable.
Oct-13-2020 15:02:24 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d51\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),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0793082
Page 169 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)YES
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
hypertensionInitial Entry
090177e196ae3d51\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-2021-5683-0793083
Page 170 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 15:02:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d51\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-2021-5683-0793084
Page 171 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Left Ventricular HypertrophyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 13:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-22-2021 12:02:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered AE still ongoing
Feb-19-2021 09:59:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY - L
VENTRICULAR
HYPERTROPHY
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0793085
Page 172 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(reported as related to
HTN) with Start Date
of 14 Sep 20, is still
indicated as
ONGOING. Please
review and if an END
date is known, please
update.
Nov-11-2020 09:14:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:10:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE still ongoing
Nov-10-2020 11:23:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
Please verify if AE is
still ongoing, or
update with END
DATE and
OUTCOME as
applicable.
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d51\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793086
Page 173 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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.
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
hypertensionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3d51\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-2021-5683-0793087
Page 174 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 15:03:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793088
Page 175 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
mitral valve regurgitationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 13:31:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-22-2021 12:02:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered AE still ongoing
Feb-19-2021 10:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY -
MITRAL VALVE
REGURGITATION
090177e196ae3d51\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-2021-5683-0793089
Page 176 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(reported as related to
HTN) with Start Date
of 14 Sep 20, is still
indicated as
ONGOING. Please
review and if an END
date is known, please
update.
Nov-11-2020 09:15:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:11:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE still ongoing
Nov-10-2020 11:24:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
Please verify if AE is
still ongoing, or
update with END
DATE and
OUTCOME as
applicable.
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d51\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793090
Page 177 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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.
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
hypertensionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3d51\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-2021-5683-0793091
Page 178 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 15:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793092
Page 179 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Tricuspid regurgitationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 13:32:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-22-2021 12:03:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered AE still ongoing
Feb-19-2021 10:01:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY -
TRICUSPID
REGURGITATION
090177e196ae3d51\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-2021-5683-0793093
Page 180 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(reported as related to
HTN) with Start Date
of 14 Sep 20, is still
indicated as
ONGOING. Please
review and if an END
date is known, please
update.
Nov-11-2020 09:16:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:12:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE still ongoing
Nov-10-2020 11:25:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
Please verify if AE is
still ongoing, or
update with END
DATE and
OUTCOME as
applicable.
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d51\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793094
Page 181 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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.
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
HypertensionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3d51\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-2021-5683-0793095
Page 182 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 15:06:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d51\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793096
Page 183 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 15:07:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 15:07:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-26-2021 18:09:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-26-2021 16:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered No underlying kidney
disease noted.
Feb-25-2021 10:23:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened clinical: in view of
response, please
update causality on
CRF. Pls also confirm
no history underlying
kidney disease.
Thanks
Feb-25-2021 10:16:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Kidney injury is
related to MRSA
infection
Feb-24-2021 13:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened clinical: pls confirm
no underlying kidney
disease. Is kidney
injury related to
contemporaneous AE
of MRSA infection
(AE #1)? Thanks
090177e196ae3d51\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-2021-5683-0793097
Page 184 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-26-2020 20:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-20-2020 13:56:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered FU submitted
10/20/2020
Oct-19-2020 13:55:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL Onset
date for new
condition Atrial
Fibrillation is 12 Sep
2020; date of
hospitalization for
MRSA infection
(SAE 2020355554).
Please submit
laboratory data
documenting this
event as a SAE safety
update
Oct-16-2020 13:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed closed per site
response
Oct-15-2020 14:40:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Does not meet
serious criteria
Oct-14-2020 13:29:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: can you
please confirm acute
kidney injury meets
or doesn't meet any
of the serious criteria
outlined in the
protocol section
10.3.2 and update
eCRF, if appropriate.
Thanks
Oct-13-2020 15:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
acute kidney injuryInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3d51\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)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0793098
Page 185 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-13-2020 15:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 13:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-22-2021 12:04:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Feb-22-2021 12:04:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/2/2020 UNK:UNKNew Information
Feb-19-2021 10:02:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY -
ACUTE KIDNEY
INJURY (reported
as related to HTN)
with Start Date of 12
Sep 20, is still
indicated as
ONGOING. Please
review and if an
END date is known,
please update.
Nov-11-2020 09:29:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:16:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE still ongoing
Nov-10-2020 11:25:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
Please verify if AE
is still ongoing, or
update with END
DATE and
OUTCOME as
applicable.
090177e196ae3d51\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)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0793099
Page 186 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
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: 11141080 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-13-2020 15:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location U
…[truncated]