Document text
Page 1 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896834
Page 2 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/1/2020
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896835
Page 3 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10191146]
2.Birth Date: /1952
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896836
Page 4 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896837
Page 5 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896838
Page 6 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896839
Page 7 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: UNK/UNK/1960
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[asthma]
Start Date: UNK/UNK/1985
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: Nov/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896840
Page 8 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2002
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Atrial Fibrillation]
Start Date: Oct/30/2019
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastric Reflux]
Start Date: UNK/UNK/2000
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoids]
Start Date: UNK/UNK/1990
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis- knees]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896841
Page 9 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Leg Cramps]
Start Date: UNK/UNK/1972
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent Back pain]
Start Date: UNK/UNK/2010
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis]
Start Date: UNK/UNK/1986
Ongoing: YES
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896842
Page 10 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [255.6]
3.Unit: LB
4.Height: [67.25]
5.Unit: in
6.Body Mass Index: [39.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: EAR
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896843
Page 11 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [248851]
3.Randomization Group: [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896844
Page 12 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BP98C0]
5.bSample ID [BP98C1]
5.cSample ID [BP98C2]
5.dSample ID [BPRMD3]
5.eSample ID [BPRMD4]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896845
Page 13 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BM864N]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896846
Page 14 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/1/2020 14:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896847
Page 15 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896848
Page 16 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896849
Page 17 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: EAR
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896850
Page 18 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP98MB]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896851
Page 19 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/22/2020 07:56
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
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896852
Page 20 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896853
Page 21 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR85SM]
5.bSample ID [BRTM3T]
5.cSample ID [BRTM3V]
5.dSample ID [BRTM3W]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896854
Page 22 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896855
Page 23 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896856
Page 24 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896857
Page 25 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896858
Page 26 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896859
Page 27 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896860
Page 28 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896861
Page 29 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896862
Page 30 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896863
Page 31 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896864
Page 32 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896865
Page 33 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896866
Page 34 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896867
Page 35 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896868
Page 36 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896869
Page 37 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896870
Page 38 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896871
Page 39 of 151
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
:Dec/17/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896872
Page 40 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896873
Page 41 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896874
Page 42 of 151
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Biliary Cancer Met
astatic Oct/27/2020 UNK
:UNK NO
End Date Time:
Dec/17/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Metastases to Liver
Oct/27/2020 UNK
:UNK NO
End Date Time:
Dec/17/2020 UNK:UNK
Repeating
Pages
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896875
Page 43 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Biliary Cancer Metastatic]
4.Start Date Time: Oct/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/17/2020 UNK:UNK
6.Toxicity Grade: 4
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?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896876
Page 44 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020420011]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896877
Page 45 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Metastases to Liver]
4.Start Date Time: Oct/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/17/2020 UNK:UNK
6.Toxicity Grade: 4
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?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896878
Page 46 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[metastatic biliary cancer]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020420011]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896879
Page 47 of 151
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896880
Page 48 of 151
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896881
Page 49 of 151
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896882
Page 50 of 151
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896883
Page 51 of 151
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896884
Page 52 of 151
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896885
Page 53 of 151
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896886
Page 54 of 151
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896887
Page 55 of 151
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896888
Page 56 of 151
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896889
Page 57 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896890
Page 58 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896891
Page 59 of 151
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896892
Page 60 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896893
Page 61 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896894
Page 62 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896895
Page 63 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896896
Page 64 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896897
Page 65 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896898
Page 66 of 151
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896899
Page 67 of 151
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896900
Page 68 of 151
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896901
Page 69 of 151
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896902
Page 70 of 151
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Feb/5/2021
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [METASTASES TO LIVER]
2.bCause of Death Status: SECONDARY CAUSE OF DEATH
Cause of Death: [BILIARY CANCER METASTATIC]
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896903
Page 71 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/17/2020
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896904
Page 72 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896905
Page 73 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896906
Page 74 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-01-2020 15:52:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896907
Page 75 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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-05-2021 09:04:44 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Dec-03-2020 13:59:39 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-19-2020 09:28:58 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-16-2020 13:53:12 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896908
Page 76 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-01-2020 15:51:58
(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
Sep-01-2020 15:51:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896909
Page 77 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020 15:52:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/1/2020Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896910
Page 78 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020 15:51:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10191146Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-30-2020 05:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-29-2020 09:19:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered submitted a follow up SAE
with correction. Thank you
Oct-29-2020 03:49:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020420011,
the date of birth was
reported as 1950 in
Safety database but was
recorded as 1952 in
AE CRF. Please confirm if
date of birth was reported.
If safety update is required,
please submit a follow-up
form.
Sep-01-2020 15:51:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020 15:52:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896911
Page 79 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-01-2020 15:52:32
(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
Sep-01-2020 15:52:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896912
Page 80 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 01:09:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site
confirmation
Oct-05-2020 09:11:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject symptoms
were not COVID
regulated
Sep-29-2020 08:52:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
09SEP2020. But
there is no COVID
Illness visit
reported in the
database. Please
clarify.
Sep-01-2020 15:52:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896913
Page 81 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-01-2020 15:53:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020 15:53:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020 15:53:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896914
Page 82 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 15:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Myopia
Start Date: UNK/UNK/1
960
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:53:32
(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
Nov-07-2020 06:41:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Charu
SabharwalQuery 1: Closed Issued on
INCORRECT
subject. Query
closed.
Nov-06-2020 13:44:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Please verify if
correct site. Pt does
not have SAE of
heroin overdose.
Nov-06-2020 01:23:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - SAE
subject with heroin
overdose; please
clarify if subject is
now understood to
be a chronic drug
user, with past
medical history of
drug abuse w/ or
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0896915
Page 83 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
w/o overdoses or
other complications
Nov-05-2020 15:14:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate Clinical - SAE
subject with heroin
overdose; please
clarify if subject is
now understood to
be a chronic drug
user, with past
medical history of
drug abuse w/ or
w/o overdoses or
other complications
Sep-01-2020 15:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MyopiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-01-2020 15:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1960Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-01-2020 15:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-01-2020 15:53:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:asthma
Start Date: UNK/UNK/1
985
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896916
Page 84 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:53:44
(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
Sep-01-2020 15:53:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
asthmaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020 15:53:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020 15:53:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-01-2020 15:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:sleep apnea
Start Date: Nov/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896917
Page 85 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:53:56
(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
Sep-01-2020 15:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
sleep apneaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-01-2020 15:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-01-2020 15:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-01-2020 15:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896918
Page 86 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:54:09
(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
Sep-01-2020 15:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-01-2020 15:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-01-2020 15:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-01-2020 15:54:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Hypercholester
olemia
Start Date: UNK/UNK/200
2
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896919
Page 87 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:54:24
(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
Sep-01-2020 15:54:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-01-2020 15:54:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-01-2020 15:54:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-01-2020 15:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Atrial Fibrilla
tion
Start Date: Oct/30/2019
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896920
Page 88 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:54:52
(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
Sep-01-2020 15:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Atrial FibrillationInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-01-2020 15:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/30/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-01-2020 15:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-01-2020 15:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Gastric Reflu
x
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896921
Page 89 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:55:08
(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
Sep-01-2020 15:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Gastric RefluxInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-01-2020 15:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-01-2020 15:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-01-2020 15:55:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:Hemorrhoids
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896922
Page 90 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:55:24
(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
Sep-01-2020 15:55:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HemorrhoidsInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-01-2020 15:55:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-01-2020 15:55:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-01-2020 15:55:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Osteoarthritis-
knees
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896923
Page 91 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:55:52
(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
Sep-01-2020 15:55:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoarthritis- kneesInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-01-2020 15:55:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-01-2020 15:55:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-01-2020 15:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:Leg Cramps
Start Date: UNK/UNK/1
972
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896924
Page 92 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:56:05
(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
Sep-01-2020 15:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Leg CrampsInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-01-2020 15:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1972Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-01-2020 15:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-01-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:11
Medical History
Term:Recurrent Bac
k pain
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896925
Page 93 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:56:17
(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
Sep-01-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Recurrent Back painInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-01-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-01-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-01-2020 15:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:12
Medical History T
erm:Allergic Rhin
itis
Start Date: UNK/UNK/1
986
Ongoing: YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896926
Page 94 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:56:29
(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
Sep-01-2020 15:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergic RhinitisInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-01-2020 15:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1986Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-01-2020 15:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896927
Page 95 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
255.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
67.25Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
39.7Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896928
Page 96 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.7
Temperature Unit: F
Temperature Location:: EARInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-01-2020 15:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896929
Page 97 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020 15:58:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020 15:58:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
248851Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896930
Page 98 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 16:24:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 16:24:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 16:24:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 16:24:38
(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-01-2020 16:24:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 16:24:53
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BP98C0Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896931
Page 99 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 16:24:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98C0Initial Entry
5.b
Date Location User Value Reason
Sep-01-2020 16:25:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP98C1Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 16:25:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98C1Initial Entry
5.c
Date Location User Value Reason
Sep-01-2020 16:25:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP98C2Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 16:25:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98C2Initial Entry
5.d
Date Location User Value Reason
Sep-01-2020 16:25:26 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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)
FDA-CBER-2021-5683-0896932
Page 100 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)Sample ID: BPRMD3
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 16:25:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRMD3Initial Entry
5.e
Date Location User Value Reason
Sep-01-2020 16:25:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRMD4Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 16:25:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRMD4Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896933
Page 101 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 16:25:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 16:25:48
(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-01-2020 16:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 16:25:48
(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-01-2020 16:25:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 16:26:04
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BM864NInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896934
Page 102 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 16:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM864NInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896935
Page 103 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020 15:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 15:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 15:58:15
(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-01-2020 15:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 14:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 15:58:15
(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-01-2020 15:58:15
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896936
Page 104 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-01-2020 15:58:15
(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-01-2020 15:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-01-2020 15:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896937
Page 105 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-01-2020 15:58:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896938
Page 106 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020 09:36:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896939
Page 107 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 09:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020 09:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Location:: EARInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 09:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 09:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020 09:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896940
Page 108 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-22-2020 09:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896941
Page 109 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 10:42:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 10:42:47
(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-22-2020 10:42:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 10:42:47
(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-22-2020 10:42:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020 10:42:57
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BP98MBInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896942
Page 110 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 10:42:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98MBInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896943
Page 111 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020 09:42:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 09:42:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 09:42:30
(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-22-2020 09:42:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020 07:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 09:42:30
(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-22-2020 09:42:30
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896944
Page 112 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-22-2020 09:42:30
(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-22-2020 09:42:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-22-2020 09:42:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896945
Page 113 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-31-2020 08:04:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-30-2020 08:41:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Form updated.
Oct-30-2020 03:31:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: 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 date
of blood sample
collection date at
visit 3.
Oct-27-2020 15:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896946
Page 114 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 15:37:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 15:37:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 15:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 15:37:05
(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.
Oct-27-2020 15:37:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020 15:37:15
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BR85SMInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896947
Page 115 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 15:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR85SMInitial Entry
5.b
Date Location User Value Reason
Oct-27-2020 15:37:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTM3TInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020 15:37:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRTM3TInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020 15:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTM3VInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-27-2020 15:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRTM3VInitial Entry
5.d
Date Location User Value Reason
Oct-27-2020 15:37:37 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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)
FDA-CBER-2021-5683-0896948
Page 116 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)Sample ID: BRTM3W
5.d Sample ID
Date Location User Value Reason
Oct-27-2020 15:37:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRTM3WInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896949
Page 117 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-30-2020 08:41:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020 08:41:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020 08:41:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896950
Page 118 of 151
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-11-2021 12:17:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-10-2021 07:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Feb-10-2021 07:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
Feb-09-2021 23:34:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020373811,
the date of death was
reported as
17Dec2020 in Safety
database but missing
in CRF. Please
confirm correct date
of death. If safety
update is required,
please submit a
follow-up form.
2. Phase of Disposition:
Date Location User Value Reason
Feb-10-2021 07:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Feb-10-2021 07:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DEATHInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896951
Page 119 of 151
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-27-2020 14:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896952
Page 120 of 151
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896953
Page 121 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 14:53:20
(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-27-2020 14:53:20
(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
Feb-15-2021
20:09:32
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
6: Clo
sedClinical The composite
term was split at the
request of Safety for
individual coding.
Feb-12-2021
17:32:15
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
6: Op
enedCLINQUERY: please
confirm that the AEs of
"Biliary Cancer Metastatic"
and "Metastases to Liver"
should be consolidated into
one fatal event of
“Metastatic Biliary
Cancer”. Please also update
the death detail CRF as
appropriate.
Feb-12-2021
17:29:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
6: Ca
ndidat
eCLINQUERY: please
confirm that "Biliary
Cancer Metastatic" and
"Metastases to Liver"
should be consolidated into
one fatal SAE of
“Metastatic Biliary
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896954
Page 122 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Cancer”. Please also update
the death detail CRF as
appropriate.
Feb-08-2021
08:51:32
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
5: Clo
sedResponse satisfies query
Feb-05-2021
12:32:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
5: An
swere
dupdated SAE sent
Feb-01-2021
17:58:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
5: Op
enedClinical Please submit a
SAE safety update with the
treatment course selected
for event 'metastatic biliary
Cancer'
Dec-09-2020
13:00:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clo
sedResponse satisfies query
Dec-08-2020
09:33:32
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: An
swere
dSAE submitted to provide
diagnostic procedure
Nov-21-2020
17:22:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Rei
ssued:
Opene
dCLINICAL Please submit
a safety update with the
diagnostic procedure /
pathologic diagnosis which
demonstrated the primary
tumor = biliary cancer
Nov-20-2020
16:52:36ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
4: CloDiscrepancy has been
closed.
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896955
Page 123 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time
(US &
Canada)sed
Nov-20-2020
15:14:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
4: An
swere
dchanged per query
Nov-20-2020
15:14:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Biliar
y Can
cer M
etastat
icchanged per query
Nov-19-2020
14:11:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
4: Op
enedMultiple concepts in the
term BILIARY
CARCINOMA
METASTATIC TO LIVER.
Split the term into
BILIARY CANCER
METASTATIC and
METASTASES TO LIVER
and submit separately.
Thank you.
Nov-19-2020
09:28:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: An
swere
dupdated per PI and SAE
follow-up has been
submitted to match
Nov-19-2020
09:28:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Biliar
y Car
cinom
a Met
astaticupdated per PI and SAE
follow-up has been
submitted to match
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0896956
Page 124 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
to Liv
er
Nov-19-2020
00:13:00
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Op
enedClinical Please split the
term, with the primary
malignancy of
CARCINOMA of
UNKOWN PRIMARY on
one line; otherwise coding
reports this a metastatic
liver cancer. Thank you.
Nov-14-2020
08:27:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedterm updated in both
database. issue resolved.
Nov-13-2020
10:31:10
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
poorly
differ
entiat
ed car
cinom
a met
astatic
to live
r, unk
nown
prima
ryThis is the PIs final
reporting diagnosis. Site
will not change (as
requested in INFORM) to
"without metastasis". SAE
will be re-submitted with
above AE event diagnosis.
Nov-13-2020
08:43:06
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dNew Information
Nov-13-2020
08:43:06
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Data
Entry
:
poorly
differNew Information
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896957
Page 125 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada) entiat
ed car
cinom
a (wit
hout
metast
asis)
Nov-11-2020
05:24:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dSAE RECON: The term
was updated to 'poorly
differentiate hepatic
carcinoma (without
metastasis'. However, term
in AE CRF was poorly
differentiated carcinoma
metastatic to liver. Please
confirm TERM and update
AE CRF.
Nov-10-2020
07:21:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dSAE updated
Nov-08-2020
18:43:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedSAE
RECON:AER#2020420011
Per the narrative, the
poorly differentiated
carcinoma was only
identified in the liver.
Please clarify whether the
final diagnosis is poorly
differentiate hepatic
carcinoma(without
metastasis)
Nov-02-2020
17:58:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Oct-29-2020
11:16:15ACV0PFEINFP6000 Query
1: AnPer PI, can not be split.
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0896958
Page 126 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time
(US &
Canada)swere
d
Oct-29-2020
09:32:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery
1: Rei
ssued:
Opene
dKindly split the term into
POORLY
DIFFERENTIATED
CARCINOMA
METASTATIC and
METASTASES TO LIVER
and submit separately.
Thank you.
Oct-28-2020
13:40:12
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dPer PI, Term will remain
the same
Oct-28-2020
06:05:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedMultiple concepts in the
term POORLY
DIFFERENTIATED
CARCINOMA
METASTATIC TO LIVER.
Split the term into
POORLY
DIFFERENTIATED
CARCINOMA
METASTATIC and
METASTASES TO LIVER
and submit separately.
Thank you.
Oct-27-2020
14:53:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
poorly
differ
entiat
ed car
cinom
a met
astatic
to live
rInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0896959
Page 127 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 14:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-05-2021 12:33:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/17/2020 UNK:UNKNew Information
Oct-27-2020 14:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021 14:10:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-10-2021 08:46:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-10-2021 08:46:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4New Information
Feb-09-2021 14:17:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: please
clarify if the toxicity
grade for Biliary
Cancer Metastatic
should be reported as 4
(protocol 10.3.3
LIFE-THREATENING:
Life-threatening
consequences; urgent
intervention indicated).
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896960
Page 128 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-27-2020 14:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial 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
Feb-05-2021 12:33:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
YES
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
YESNew Information
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896961
Page 129 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-13-2020 10:38:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Safety notified and
will continue FU as
part of SAE
reconciliation
process.
Nov-13-2020 08:45:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered per records
carcinoma on liver
Nov-11-2020 02:25:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened GPDCLIN: It is
unclear if this is a
primary
hepatocellular
carcinoma or
another primary
tumor that sent a
metastasis to the
liver. If the later is
correct, please
clarify what is the
primary tumor and
ensure AE term is
updated as
applicable.
Nov-05-2020 10:16:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered on liver
Oct-30-2020 08:45:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened GPDCLIN: AE term
suggests that the
liver lesion is
considered to be a
metastasis rather
than a primary liver
tumor. please
confirm and if
correct, where is the
primary tumor?
Oct-29-2020 09:20:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Location is Liver
Oct-29-2020 03:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896962
Page 130 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-29-2020 03:16:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened GPDCLIN: thank
you for your
response, please
clarify what is the
type and location of
the primary tumor.
Oct-28-2020 13:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE poorly
differentiated
carcinoma
metastatic to liver:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-28-2020 13:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896963
Page 131 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
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 13:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important seri
ous event
YESTranscription Error
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896964
Page 132 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-28-2020 11:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: New
metastatic cancer is
reported as
non-serious AE.
Please clarify what
is the primary
tumor that spread to
the liver and
consider reporting
this malignant
cancer also as
SAE(i.e. important
medical event).
else, please clarify.
Oct-27-2020 14:53:20
(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-27-2020 14:53:20
(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-27-2020 14:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896965
Page 133 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-27-2020 14:53:20
(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-27-2020 14:53:20
(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-27-2020 14:53:20
(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
Feb-05-2021
12:34:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Closed Close Auto Query
Feb-05-2021
12:33:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Closed Close Auto Query
Feb-05-2021
12:33:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Opened Response to "What was the outcome
of this adverse event?" is 'Fatal' but
Date of Collection / Notification of
Death on the Death Details form is
not completed. Please review and
update as appropriate.
Feb-05-2021
12:33:30
(UTC-06:00)
Central Time (USACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened For AE Biliary Cancer Metastatic:
Response to "What was the outcome
of this adverse event?" is 'Fatal' but
"Is the adverse event still ongoing?"
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896966
Page 134 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada) is marked 'Yes'.
Feb-05-2021
12:33:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FATALNew Information
Nov-06-2020
05:05:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Nov-05-2020
09:54:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered SAE Submitted to reflect not
recovered/resolved
Oct-30-2020
05:40:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:
OpenedSAE
RECON:AER#2020420011,outcome
was reported as UNKNOWN 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.
Oct-29-2020
09:20:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Oct-29-2020
09:20:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DTranscription Error
Oct-29-2020
09:20:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For AE poorly differentiated
carcinoma metastatic to liver:
Response to "What was the outcome
of this adverse event?" is 'Unknown'
but End Date/Time is provided or "Is
the adverse event still ongoing?" is
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896967
Page 135 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
marked "Yes".
Oct-29-2020
09:20:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
Oct-29-2020
09:20:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
Oct-29-2020
01:09:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened DM: The response for "What was
the outcome of this adverse event?"
is missing. Kindly review and
update.
Oct-27-2020
14:57:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-27-2020
14:57:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-27-2020
14:53:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE poorly differentiated
carcinoma metastatic to liver:
Response to "What was the outcome
of this adverse event?" is 'Unknown'
but End Date/Time is provided or "Is
the adverse event still ongoing?" is
marked "Yes".
Oct-27-2020
14:53:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896968
Page 136 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-10-2021 12:14:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-10-2021 08:46:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-10-2021 08:46:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESNew Information
Feb-09-2021 06:57:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: AE Outcome
is FATAL but "Did
the adverse event
cause the subject to
be discontinued
from the study" is
marked as No.
Kindly review and
update, else clarify.
Thank you.
Oct-27-2020 14:53:20
(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
Oct-29-2020 03:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020420011Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896969
Page 137 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-20-2020 15:16:38
(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
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Metastases to LiverInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-10-2021 08:42:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-10-2021 08:42:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/17/2020 UNK:UNKNew Information
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896970
Page 138 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-10-2021 07:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing. Please
review and update
as appropriate.
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021 14:16:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-10-2021 08:43:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-10-2021 08:43:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4New Information
Feb-09-2021 14:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: please
clarify if the toxicity
grade for Metastases to
Liver should be
reported as 4 (protocol
10.3.3
LIFE-THREATENING:
Life-threatening
consequences; urgent
intervention indicated).
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial 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
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896971
Page 139 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
Feb-14-2021 09:17:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-12-2021 11:13:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Feb-12-2021 11:13:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
YES
Did this serious event requir
e or prolong hospitalization?
NO
Did this serious event result
in persistent or significant di
sability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious event
YESTranscription Error
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896972
Page 140 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-12-2021 11:03:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened GPDCLIN:
Outcome of AE is
reported as fatal
however, the
answer to the
question: Did this
serious event result
in death? is NO.
please review and
update as
applicable. Else,
please clarify.
Nov-23-2020 03:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Metastases
to Liver: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization?
NO
Did this serious event result
in persistent or significant di
sability/incapacity?Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896973
Page 141 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious event
YES
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
Nov-20-2020 15:16:38
(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
Feb-08-2021 12:26:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-05-2021 09:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-05-2021 09:04:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
metastatic biliary cancerTranscription Error
Feb-01-2021 17:51:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Other
reason for Mets to
Liver is 'found
through checkup';
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896974
Page 142 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
however, SAE
reports the mets are
due to metastatic
biliary cancer.
Please review other
cause of mets in
liver, and update as
appropriate
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
found through medical ch
eck-upInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896975
Page 143 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-10-2021 08:43:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-10-2021 08:43:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATALNew Information
Feb-10-2021 08:42:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Metastases
to Liver: Response
to "What was the
outcome of this
adverse event?" is
'Not Recovered/Not
Resolved' but AE
End Date/Time is
present.
Nov-20-2020 15:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-16-2021 14:14:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-16-2021 13:30:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Clinical following
up in another query
Feb-16-2021 11:23:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered updated to respond
to query
Feb-16-2021 11:16:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened More than 1 AE for
this patient has "Did
the adverse event
cause the subject to
be discontinued
from the study?"
marked as 'Yes'.
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896976
Page 144 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-16-2021 11:16:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-16-2021 11:16:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESNew Information
Feb-14-2021 09:19:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened GPDCLIN: Please
clarify your
response as the
answer to this
question is NO
while AE is fatal.
Feb-12-2021 11:15:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-12-2021 11:15:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Feb-12-2021 11:12:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened More than 1 AE for
this patient has "Did
the adverse event
cause the subject to
be discontinued
from the study?"
marked as 'Yes'.
Feb-12-2021 11:12:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-12-2021 11:12:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESNew Information
Feb-12-2021 11:05:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN:
Outcome of this AE
is fatal however, the
answer to the
question whether the
AE caused study
discontinuation is
NO. Please review
and update as
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896977
Page 145 of 151
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
applicable or clarify.
Nov-20-2020 15:16:38
(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
Nov-23-2020 03:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020420011Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896978
Page 146 of 151
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Feb-15-2021
17:48:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Feb-10-2021
14:05:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Feb-10-2021
12:26:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Feb-10-2021
08:45:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered FUP CRF has been updated.
Feb-10-2021
08:45:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per query
Feb-10-2021
08:44:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Site was not made aware of
Subject's passing until this
date.
Feb-10-2021
07:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Date of Collection /
Notification of Death is
greater than the Date of
Completion/Discontinuation
/Death on the Disposition
form 17/Dec/2020. Please
review and update as
appropriate
Feb-09-2021
14:15:14
(UTC-06:00) CentralACV0PFEINFP6000 Query 2: Opened CLINQUERY: Death form
is entered but disposition
follow-up (FUP) is not
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0896979
Page 147 of 151
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) complete. Please verify and
update the FUP form, else
clarify.
Feb-08-2021
17:43:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please complete
Follow up CRF.
Feb-05-2021
12:34:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/5/2021Initial Entry
2.a
Date Location User Value Reason
Feb-08-2021 09:28:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cause of De
ath Status:PRIMARY CAU
SE OF DEATH
Cause of De
ath:METASTASES T
O LIVERTranscription Error
Feb-05-2021 12:34:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cause of D
eath Status
:PRIMARY CAUS
E OF DEATH
Cause of D
eath:Biliary Carcinoma
Metastatic to LiverInitial Entry
2.a Cause of Death Status:
Date Location User Value Reason
Feb-05-2021 12:34:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CAUSE OF DEATHInitial Entry
2.a Cause of Death:
Date Location User Value Reason
Feb-08-2021
10:48:19
(UTC-06:00)
Central TimeACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clo
sedDiscrepancy has
been closed.
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (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)
FDA-CBER-2021-5683-0896980
Page 148 of 151
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Feb-08-2021
09:28:33
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Feb-08-2021
09:28:33
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
METASTAS
ES TO LIVE
RTranscription
Error
Feb-05-2021
15:57:04
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Ope
nedMultiple
concepts in the
term BILIARY
CARCINOMA
METASTATIC
TO LIVER. Split
the term into
BILIARY
CANCER
METASTATIC
and
METASTASES
TO LIVER and
submit
separately.
Thank you.
Feb-05-2021
12:34:45
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Biliary Carci
noma Metast
atic to LiverInitial Entry
2.b
Date Location User Value Reason
Feb-08-2021 09:28:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cause of D
eath Status
:SECONDARY C
AUSE OF DEAT
HTranscription Error
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0896981
Page 149 of 151
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Cause of D
eath:BILIARY CANC
ER METASTATI
C
Feb-08-2021 09:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cause of D
eath Status
:PRIMARY CAUS
E OF DEATH
Cause of D
eath:BILIARY CANC
ER METASTATI
CInitial Entry
2.b Cause of Death Status:
Date Location User Value Reason
Feb-08-2021 09:28:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-08-2021 09:28:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SECONDARY CAUSE OF DE
ATHTranscription Error
Feb-08-2021 09:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened There is more than
one primary cause
of death reported.
Please update so
that there is one
Primary Cause of
death, noting that
there can be
multiple Secondary
Causes of death.
Feb-08-2021 09:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CAUSE OF DEATHInitial Entry
2.b Cause of Death:
Date Location User Value Reason
Feb-08-2021 09:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BILIARY CANCER METASTA
TICInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896982
Page 150 of 151
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-10-2021 07:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-30-2020 08:41:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-01-2020 15:58:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-01-2020 15:53:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-10-2021 07:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/17/2020Initial Entry
Oct-30-2020 08:41:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Sep-01-2020 15:58:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/1/2020Initial Entry
Sep-01-2020 15:53:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/1/2020Initial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896983
Page 151 of 151
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-16-2020 13:46:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e24\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896984