Document text
Page 1 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991081
Page 2 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/20/2020
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991082
Page 3 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12351205]
2.Birth Date: 1963
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991083
Page 4 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991084
Page 5 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991085
Page 6 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991086
Page 7 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TOURETTE'S SYNDROME]
Start Date: UNK/UNK/1973
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Afib-rate controlled]
Start Date: Jan/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[amenorrhea]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991087
Page 8 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991088
Page 9 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/20/2020
2.Weight: [284.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [39.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991089
Page 10 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991090
Page 11 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/20/2020
2.Randomization Number: [271434]
3.Randomization Group: [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991091
Page 12 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1DNW]
5.bSample ID [BLD41V]
5.cSample ID [BLD41X]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991092
Page 13 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1DNR]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991093
Page 14 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: Oct/20/2020 13:08
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
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991094
Page 15 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991095
Page 16 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991096
Page 17 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Nov/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991097
Page 18 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991098
Page 19 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP0YHG]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991099
Page 20 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: Nov/11/2020 13:39
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
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991100
Page 21 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991101
Page 22 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/10/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP0YMY]
5.bSample ID [BSMR3F]
5.cSample ID [BSMR3B]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991102
Page 23 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991103
Page 24 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991104
Page 25 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991105
Page 26 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991106
Page 27 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991107
Page 28 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991108
Page 29 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991109
Page 30 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991110
Page 31 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991111
Page 32 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991112
Page 33 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991113
Page 34 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991114
Page 35 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991115
Page 36 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991116
Page 37 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991117
Page 38 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991118
Page 39 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 injection site pain Nov/12/2020 12
:00 NO
End Date Time:
Nov/15/2020 08:00
Repeating
Pages
2.ADVERSE E
VENT 2 pyrexia Nov/12/2020 12
:00 NO
End Date Time:
Nov/15/2020 08:00
Repeating
Pages
3.ADVERSE E
VENT 3 chills Nov/12/2020 12
:00 NO
End Date Time:
Nov/15/2020 08:00
Repeating
Pages
4.ADVERSE E
VENT 4 body aches, myalgia Nov/12/2020 20
:20 NO
End Date Time:
Nov/15/2020 08:00
Repeating
Pages
5.ADVERSE E
VENT 5 Cervical lymphadenopath
y, left side Nov/1/2020 06:
00 YES Repeating
Pages
6.ADVERSE E
VENT 6 squamous cell carcinoma
of oropharynx Oct/23/2020 UN
K:UNK YES Repeating
Pages
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991119
Page 40 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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)[injection site pain]
4.Start Date Time: Nov/12/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/15/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991120
Page 41 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991121
Page 42 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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)[pyrexia]
4.Start Date Time: Nov/12/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/15/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991122
Page 43 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991123
Page 44 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chills]
4.Start Date Time: Nov/12/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/15/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991124
Page 45 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991125
Page 46 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[body aches, myalgia]
4.Start Date Time: Nov/12/2020 20:20
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/15/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991126
Page 47 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991127
Page 48 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Cervical lymphadenopathy, left side]
4.Start Date Time: Nov/1/2020 06:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[tooth fracture]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991128
Page 49 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991129
Page 50 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[squamous cell carcinoma of oropharynx]
4.Start Date Time: Oct/23/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991130
Page 51 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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:
[human papilloma virus]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021117380]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991131
Page 52 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991132
Page 53 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991133
Page 54 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991134
Page 55 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: //
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991135
Page 56 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defin
ed IdentifierCategory for MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1.1 CONCOMITANT IMMUNOS
UPPRESSIVE THERAPY NO Cisplatin 220 Repeating
Pages
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991136
Page 57 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Cisplatin]
5.Dose: [220]
6.Dose Unit: mg
7.Dose Frequency: UNKNOWN
8.Route: INTRAVENOUS
9.Start Date: Feb/1/2021
10.Ongoing? YES
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991137
Page 58 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryTreatment Id
entifierCon Non-Drug Treatments
Pre-specifiedTreatmentStart Da
teForm Instanc
e
1.RADIATION TH
ERAPY 1 YES RADIATION TRE
ATMENT Jan/29/2
021 Repeating
Pages
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991138
Page 59 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Radiation Treatment
1.Category: RADIATION THERAPY
2.What is the treatment Identifier? [1]
3.Concomitant Non-drug Treatment
Pre-specified:YES
4.Treatment: [RADIATION TREATMENT]
5.Start Date: Jan/29/2021
6.Ongoing? YES
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991139
Page 60 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991140
Page 61 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991141
Page 62 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991142
Page 63 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991143
Page 64 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991144
Page 65 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991145
Page 66 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991146
Page 67 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991147
Page 68 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991148
Page 69 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991149
Page 70 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991150
Page 71 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991151
Page 72 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991152
Page 73 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991153
Page 74 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991154
Page 75 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991155
Page 76 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991156
Page 77 of 175
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991157
Page 78 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991158
Page 79 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991159
Page 80 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991160
Page 81 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/10/2020
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991161
Page 82 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991162
Page 83 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991163
Page 84 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-20-2020 13:24:08 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991164
Page 85 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-20-2020 13:38:21 (UTC-06:00) Central
Time (US & Canada)Post menopausal
Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991165
Page 86 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Oct-20-2020 13:38:21 (UTC-06:00) Central
Time (US & Canada)Post menopausal
Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991166
Page 87 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Oct-20-2020 13:38:21 (UTC-06:00) Central
Time (US & Canada)Post menopausal
Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991167
Page 88 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-20-2020 13:38:21 (UTC-06:00) Central
Time (US & Canada)Post menopausal
Not Applicable
3Oct-20-2020 13:36:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991168
Page 89 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Oct-20-2020 13:38:21 (UTC-06:00) Central
Time (US & Canada)Post menopausal
Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991169
Page 90 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Oct-20-2020 13:38:21 (UTC-06:00) Central
Time (US & Canada)Post menopausal
Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991170
Page 91 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-20-2020 13:38:21 (UTC-06:00) Central
Time (US & Canada)Post menopausal
Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991171
Page 92 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-20-2020 13:38:21 (UTC-06:00) Central
Time (US & Canada)Post menopausal
Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991172
Page 93 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aOct-20-2020 13:38:21 (UTC-06:00) Central
Time (US & Canada)Post menopausal
Not Applicable
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991173
Page 94 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 18:39:04 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Vanchiere Approved Jan-20-2021 18:09:53 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnVanchiere, 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.
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991174
Page 95 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-20-2020 11:53:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-20-2020 11:53:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991175
Page 96 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-20-2020 11:54:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/20/2020Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991176
Page 97 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-20-2020 11:53:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12351205Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-20-2020 11:52:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1963Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-20-2020 11:54:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-20-2020 11:54:50
(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
Oct-20-2020 11:54:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991177
Page 98 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 06:37:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-05-2020 10:49:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered awaiting source
documentation from
primary care doctor.
Amenorrhea for 15
months.
Nov-02-2020 15:53:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
confirm why
pregnancy Test was
not done or update
Medical History
with Reason.
Oct-20-2020 13:22:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991178
Page 99 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-20-2020 13:25:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020 13:25:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020 13:25:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991179
Page 100 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020 09:01:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:TOURETTE'S S
YNDROME
Start Date: UNK/UNK/197
3
Ongoing: YESChanged
Information
Oct-20-2020 13:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Tourrette's
Start Date: UNK/UNK/
1973
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-20-2020 13:31:50
(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
Oct-21-2020
10:32:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Cl
osedDiscrepancy has
been closed.
Oct-21-2020
09:01:03ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredChanged
Information
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0991180
Page 101 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-06:00)
Central Time
(US & Canada)
Oct-21-2020
09:01:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
TOURETT
E'S SYND
ROMEChanged
Information
Oct-21-2020
04:55:46
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: O
penedClarify
TOURRETTE'S
as follows...The
term appears
incomplete. Are
you reporting
TOURETTE'S
SYNDROME? If
so, update the
verbatim term as
such. Otherwise
clarify and edit
the term. Thank
you.
Oct-20-2020
13:31:50
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
Tourrette'sInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-20-2020 13:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1973Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-20-2020 13:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0991181
Page 102 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b
Date Location User Value Reason
Oct-20-2020 13:33:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Afib-rate cont
rolled
Start Date: Jan/UNK/202
0
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-20-2020 13:33:07
(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
Oct-20-2020 13:33:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Afib-rate controlledInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-20-2020 13:33:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-20-2020 13:33:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991182
Page 103 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Feb-19-2021 07:41:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:amenorrhea
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Feb-19-2021 07:41:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 07:41:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
amenorrheaInitial Entry
1.c Start Date:
Date Location User Value Reason
Feb-19-2021 07:41:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Feb-19-2021 07:41:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991183
Page 104 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-20-2020 13:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991184
Page 105 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
284.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991185
Page 106 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
39.6Initial Entry
7.a
Date Location User Value Reason
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 37.1
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991186
Page 107 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-20-2020 13:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991187
Page 108 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-20-2020 13:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-20-2020 13:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-22-2021 10:53:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-19-2021 07:41:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-18-2021 08:07:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLINQUERY2-
Thank you for your
response. MedHx
CRF now unlocked
for edits.
Feb-17-2021 06:40:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered subject with
amenorrhea x 15
months. please
unfreeze MH to
add. Deviation
reported.
Feb-17-2021 01:23:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
Pregnancy test was
reported as NOT
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991188
Page 109 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
APPLICABLE.
However, subject is
<60 yrs old and has
no MH of surgical
sterilization. Test is
required for
WOCBP. If reason
exists that test was
not necessary,
please update MH.
Feb-16-2021 15:14:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate CLINQUERY -
Pregnancy test was
reported as NOT
APPLICABLE.
However, subject is
<60 yrs old and has
no MH of surgical
sterilization. Test is
required for
WOCBP. If reason
exists that test was
not necessary,
please update MH.
Oct-20-2020 13:36:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-20-2020 13:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-20-2020 13:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991189
Page 110 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6.a
Date Location User Value Reason
Oct-20-2020 13:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defi
ned Identifier
:Not Applicable
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: Not Applicable
Not Done:: Not ApplicableInitial Entry
Oct-20-2020 13:36:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defi
ned Identifier
:
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-20-2020 13:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-20-2020 13:36:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991190
Page 111 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-20-2020 13:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-20-2020 13:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991191
Page 112 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-20-2020 13:41:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-20-2020 13:41:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
271434Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991192
Page 113 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 13:42:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 13:42:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 13:44:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 13:42:11
(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-20-2020 13:42:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 13:44:29
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BP1DNWInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991193
Page 114 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 13:44:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1DNWInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 13:44:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD41VInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 13:44:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD41VInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 13:45:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD41XInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 13:45:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD41XInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0991194
Page 115 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 13:42:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 13:42:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 13:45:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 13:42:26
(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-20-2020 13:42:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 13:45:24
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BP1DNRInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0991195
Page 116 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 13:45:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1DNRInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0991196
Page 117 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-20-2020 13:43:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-20-2020 13:43:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-20-2020 13:43:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-20-2020 13:43:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020 13:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-20-2020 13:43:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991197
Page 118 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-20-2020 13:43:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-20-2020 13:43:13
(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
Oct-20-2020 13:43:13
(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
Oct-20-2020 13:43:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991198
Page 119 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-20-2020 13:43:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991199
Page 120 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 13:42:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991200
Page 121 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Nov-11-2020 13:53:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
2.a
Date Location User Value Reason
Nov-11-2020 13:53:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-11-2020 13:53:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-11-2020 13:53:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-11-2020 13:53:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991201
Page 122 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Temperature Location:
Date Location User Value Reason
Nov-11-2020 13:53:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991202
Page 123 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-11-2020 13:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-11-2020 13:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-11-2020 13:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-11-2020 13:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-11-2020 13:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991203
Page 124 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-11-2020 13:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-11-2020 13:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-11-2020 13:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-11-2020 13:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991204
Page 125 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 13:42:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 13:42:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020 15:57:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-11-2020 13:42:52
(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.
Nov-11-2020 13:42:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020 15:57:06
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BP0YHGInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991205
Page 126 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Nov-11-2020 15:57:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP0YHGInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991206
Page 127 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-11-2020 14:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-11-2020 14:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-11-2020 14:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-11-2020 14:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020 13:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-11-2020 14:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991207
Page 128 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-11-2020 14:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-11-2020 14:33:39
(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
Nov-11-2020 14:33:39
(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
Nov-11-2020 14:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991208
Page 129 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-10-2020 13:57:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/10/2020Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0991209
Page 130 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-10-2020 13:57:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-10-2020 13:57:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-10-2020 15:25:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-10-2020 13:57:59
(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.
Dec-10-2020 13:57:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/10/2020Initial Entry
5.a
Date Location User Value Reason
Dec-10-2020 15:25:25 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0991210
Page 131 of 175
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-06:00) Central
Time (US & Canada)Sample ID: BP0YMY
5.a Sample ID
Date Location User Value Reason
Dec-10-2020 15:25:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP0YMYInitial Entry
5.b
Date Location User Value Reason
Dec-10-2020 15:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMR3FInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-10-2020 15:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMR3FInitial Entry
5.c
Date Location User Value Reason
Dec-10-2020 15:26:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMR3BInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-10-2020 15:26:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMR3BInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991211
Page 132 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-19-2020 15:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991212
Page 133 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991213
Page 134 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991214
Page 135 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991215
Page 136 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0991216
Page 137 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991217
Page 138 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-19-2020 15:33:06
(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-19-2020 15:33:06
(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 Value Reason
Nov-20-2020
12:19:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: C
losedDiscrepancy has
been closed.
Nov-20-2020
10:26:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredper query
Nov-20-2020
10:26:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
injection si
te painper query
Nov-19-2020
18:23:04
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: O
penedClarify SORE
ARM AT
INJECTION
SITE as
follows...Are you
reporting
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0991218
Page 139 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
INJECTION
SITE PAIN?
INJECTION
SITE EROSION?
INJECTION
SITE
EXFOLIATION?
INJECTION
SITE PLAQUE?
INJECTION
SITE
ERUPTION? If
so, update the
verbatim term as
such. Otherwise
clarify SORE in
the context and
edit the verbatim
accordingly.
Thank you.
Nov-19-2020
15:33:06
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
sore arm at
injection si
teInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-19-2020 15:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-19-2020 15:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/15/2020 08:00Initial Entry
6. Toxicity Grade:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991219
Page 140 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-19-2020 15:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-19-2020 15:33:06
(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
Nov-19-2020 15:33:06
(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
Nov-19-2020 15:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-19-2020 15:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991220
Page 141 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-19-2020 15:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-19-2020 15:33:06
(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
Nov-19-2020 15:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-19-2020 15:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991221
Page 142 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-19-2020 15:35:28
(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-19-2020 15:35:28
(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-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pyrexiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/15/2020 08:00Initial Entry
6. Toxicity Grade:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991222
Page 143 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-19-2020 15:35:28
(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
Nov-19-2020 15:35:28
(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
Nov-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991223
Page 144 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-19-2020 15:35:28
(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
Nov-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-19-2020 15:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991224
Page 145 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-19-2020 15:36:43
(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-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/15/2020 08:00Initial Entry
6. Toxicity Grade:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991225
Page 146 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-19-2020 15:36:43
(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
Nov-19-2020 15:36:43
(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
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991226
Page 147 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-19-2020 15:36:43
(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
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-19-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991227
Page 148 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
body aches, myalgiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020 20:20Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/15/2020 08:00Initial Entry
6. Toxicity Grade:
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991228
Page 149 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-19-2020 15:40:41
(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
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991229
Page 150 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-19-2020 15:40:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991230
Page 151 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cervical lymphadenopathy, lef
t sideInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/1/2020 06:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-18-2020 08:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 1: Closed Response satisfies
query
Dec-14-2020 11:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered currently ongoing
pending ENT appt
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(
(b) (4)
FDA-CBER-2021-5683-0991231
Page 152 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-14-2020 05:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 1: Opened Clin: Please
confirm if this AE
is still ongoing
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-10-2020 16:07:49
(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
Dec-10-2020 16:07:49
(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
Dec-10-2020 16:07:49
(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:Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991232
Page 153 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
OTHER
If Other, specify:
tooth fracture
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-10-2020 16:07:49
(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
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-10-2020 16:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991233
Page 154 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-09-2021 12:44:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 4: Closed Response satisfies
query
Mar-09-2021 10:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered added
Mar-04-2021 06:00:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 4: Opened Medical monitor_ If
the subject will be
receiving treatment
with chemotherapy,
per CRF CG V12,
section 8.53., details
of prohibited
medications should
be recorded on CRF.
Kindly reassess and
update the PROHIB
CM accordingly.
Thank you.
Mar-04-2021 05:58:18
(UTC-06:00) CentralACV0PFEINFP6000 Giselle
CastilloQuery 3: Closed Response satisfies
query
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0991234
Page 155 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Time (US & Canada)
Mar-02-2021 00:39:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed event term updated in
SDB. Issue resolved
Mar-01-2021 11:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Pending SDB update
Feb-26-2021 01:11:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidate Pending SDB update
Feb-25-2021 10:43:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered FU form faxed
25-Feb-2021
Feb-25-2021 10:42:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Fu form faxed
25-Feb-2021
Feb-16-2021 11:00:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Opened Medical Monitor_
information on
clinical presentation,
context of diagnosis
(PCP/ED), workup
and Med records are
missing in safety
report. Pls provide
further information
about the event in a
FU form. Thanks.
Feb-15-2021 04:14:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2021117380,the
term was reported as
'Squamous cell
carcinoma' in Safety
DB while recorded as
'squamous cell
carcinoma of
oropharynx' in AE
CRF. Please confirm
correct term.If safety
update is required,
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
(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-2021-5683-0991235
Page 156 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
please submit a
follow-up form.
Feb-11-2021 09:01:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Samuel
DychterQuery 1: Closed Response satisfies
query
Feb-10-2021 10:00:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-10-2021 10:00:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
squamous cell carcinoma of
oropharynxNew Information
Feb-09-2021 13:41:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Samuel
DychterQuery 1: Opened GPD Clin: Please add
the anatomical area of
the cancer.
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
squamous cell carcinomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0991236
Page 157 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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-10-2021 19:50:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-10-2021 10:00:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE squamous
cell carcinoma of
oropharynx:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE squamous
cell carcinoma:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bi
rth defect?
NO
Did this serious event result in
death?
NOInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991237
Page 158 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabi
lity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious 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
Feb-05-2021 18:39:04
(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-26-2021
02:59:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: ClosedResponse
satisfies query
Feb-25-2021
10:42:09
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Query 1
: Answe
redsubject tumor
is P16 positive
which is a
marker for
HPV. Subject
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991238
Page 159 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Canada) did not have
prior
knowledge of
HPV diagnosis,
therefore this
information
will not be
added to
medical history
Feb-23-2021
01:50:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Open
edDM: ‘If not
related to study
treatment
other’ field, in
comment field
‘human
papilloma
virus’ is
entered. Please
confirm any
symptoms, AEs
or other key
data should be
collected or
MEDHX
should be
updated. If yes
then update
CRF. Else
clarify.
Feb-09-2021
04:45:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Cand
idatePending SAE
data to be
updated
Feb-08-2021
15:37:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redFU SAE form
has been
submitted.
Please advise if
further action is
needed on the
field.
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991239
Page 160 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Feb-08-2021
00:18:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1
: Opene
dPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [human
papilloma
virus]. Any
symptoms, AEs
or other key
data should be
collected on the
appropriate
page. Please
review and
update as
necessary.
Feb-05-2021
18:39:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atment
(s), thi
s event
is due
to:
OTH
ER
If
Oth
er,
speInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b)
(4)
FDA-CBER-2021-5683-0991240
Page 161 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
cify
:
h
u
m
an
pa
pi
ll
o
m
a
vi
ru
s
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-05-2021 18:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-05-2021 18:39:04 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0991241
Page 162 of 175
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-06:00) Central
Time (US & Canada)NOT RECOVERED/NOT RES
OLVED
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-05-2021 18:39:04
(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
Feb-10-2021 19:50:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021117380Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0991242
Page 163 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit
Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991243
Page 164 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CONCOMITANT IMMUNOSU
PPRESSIVE THERAPYInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CisplatinInitial Entry
5. Dose:
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
220Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991244
Page 165 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6. Dose Unit:
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
8. Route:
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
INTRAVENOUSInitial Entry
9. Start Date:
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
10. Ongoing?
Date Location User Value Reason
Mar-09-2021 10:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0991245
Page 166 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Mar-09-2021 10:10:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991246
Page 167 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 10:10:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
RADIATION THERAPYInitial Entry
2. What is the treatment Identifier?
Date Location User Value Reason
Mar-09-2021 10:10:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Mar-09-2021 10:10:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
YESInitial Entry
4. Treatment:
Date Location User Value Reason
Mar-09-2021 10:10:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
RADIATION TREATMENTInitial Entry
5. Start Date:
Date Location User Value Reason
Mar-09-2021 10:10:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
6. Ongoing?
Date Location User Value Reason
Mar-09-2021 10:10:57
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991247
Page 168 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Time (US & Canada)
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991248
Page 169 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-10-2020 13:58:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-10-2020 13:58:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-10-2020 13:58:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0991249
Page 170 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021 15:34:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991250
Page 171 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-08-2021 15:35:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991251
Page 172 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-08-2021 15:34:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-08-2021 15:34:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991252
Page 173 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-10-2020 13:58:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-20-2020 13:41:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-20-2020 13:25:03
(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
19:51:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Event added in PDB and
SDB
Feb-09-2021
12:33:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered FU SAE form was faxed
08-Feb-2021. Thank you!
Feb-09-2021
12:14:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Open
edSAE
RECON:AER#2021117380
Head and Neck is in SDB.
Please send a follow-up
Safety form to have the
Safety Database update
Feb-08-2021
08:59:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered originally, we did not have
pathology report of shat
type of heac and neck
cancer. it has now been
identified as squamous cell
carcinoma which was
added to the CRF. please
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991253
Page 174 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
advise if something needs
to be changed.
Feb-08-2021
08:47:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Open
edSAE
RECON:AER#2021117380
Thank you for response
however head and neck
cancer was reported as
serious in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Feb-08-2021
08:43:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered updated
Feb-05-2021
12:19:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021117380
head and neck cancer was
reported as serious in
Safety database but
missing in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form.
Dec-10-2020
13:58:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/10/2020Initial Entry
Oct-20-2020
13:41:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Oct-20-2020
13:25:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991254
Page 175 of 175
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-20-2021 15:25:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3033\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0991255