Document text
Page 1 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902209
Page 2 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902210
Page 3 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10281059]
2.Birth Date: /1972
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:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902211
Page 4 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902212
Page 5 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902213
Page 6 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902214
Page 7 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: Aug/UNK/2016
Ongoing: NO
End Date:
Nov/UNK/2016
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Asthma, Allergy Induced]
Start Date: UNK/UNK/1992
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[GERD]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902215
Page 8 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypothyroidism]
Start Date: Aug/30/2019
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Polycystic Ovarian Disease]
Start Date: UNK/UNK/2003
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1985
Ongoing: YES
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902216
Page 9 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Wisdom Teeth Extraction]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1994
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Amoxicillin Allergy]
Start Date: UNK/UNK/1992
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Ceftin Allergy]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902217
Page 10 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [150.4]
3.Unit: LB
4.Height: [64.75]
5.Unit: in
6.Body Mass Index: [25.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902218
Page 11 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/26/2020
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:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902219
Page 12 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [66525]
3.Randomization Group: [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902220
Page 13 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BN61GJ]
5.bSample ID [BN61GK]
5.cSample ID [BN61GL]
5.dSample ID [BLBC1P]
5.eSample ID [BLBC1R]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902221
Page 14 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BN61FG]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902222
Page 15 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/26/2020 10:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902223
Page 16 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902224
Page 17 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902225
Page 18 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902226
Page 19 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/16/2020
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:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902227
Page 20 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP92M8]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902228
Page 21 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/16/2020 10:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902229
Page 22 of 200
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902230
Page 23 of 200
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BR8ZYL]
5.bSample ID [BR8ZYM]
5.cSample ID [BR8ZYN]
5.dSample ID [BLBCGL]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902231
Page 24 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902232
Page 25 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902233
Page 26 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902234
Page 27 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902235
Page 28 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902236
Page 29 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902237
Page 30 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902238
Page 31 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902239
Page 32 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902240
Page 33 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902241
Page 34 of 200
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902242
Page 35 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902243
Page 36 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902244
Page 37 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902245
Page 38 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
1.ADVERS
E EVENT
1 diarrhea Sep/1/2020
UNK:UNK NO
End Date Time:
Sep/1/2020 UN
K:UNK
Repeating
Pages
2.ADVERS
E EVENT
2 invasive ductal carcin
oma stage 1B, left bre
ast Sep/30/2020
UNK:UNK YES Repeating
Pages
3.ADVERS
E EVENT
3 left breast lump Aug/27/202
0 UNK:UN
K NO
End Date Time:
Sep/29/2020 U
NK:UNK
Repeating
Pages
4.ADVERS
E EVENT
4 left arm soreness at in
jection site. Aug/27/202
0 UNK:UN
K NO
End Date Time:
Aug/29/2020 U
NK:UNK
Repeating
Pages
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902246
Page 39 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[diarrhea]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/1/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902247
Page 40 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902248
Page 41 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902249
Page 42 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[invasive ductal carcinoma stage 1B, left breast]
4.Start Date Time: Sep/30/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902250
Page 43 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
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:
[breast cancer]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902251
Page 44 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[2020398901]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902252
Page 45 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[left breast lump]
4.Start Date Time: Aug/27/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/29/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902253
Page 46 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[breast lump]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902254
Page 47 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902255
Page 48 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[left arm soreness at injection site.]
4.Start Date Time: Aug/27/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/29/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902256
Page 49 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902257
Page 50 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902258
Page 51 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902259
Page 52 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902260
Page 53 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902261
Page 54 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902262
Page 55 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-
Defined I
dentifierCategory for Medi
cationConcomitant
Medications
Pre-specifiedName o
f Medic
ationDose
Descri
ptionForm Insta
nce
1. DELETED 1 CORTICOSTEROI
DS NO hydroco
rtisone 100 Repeating
Pages
2. 2 CONCOMITANT I
MMUNOSUPPRE
SSIVE THERAPY NO paclitax
el 138 Repeating
Pages
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902263
Page 56 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: CORTICOSTEROIDS
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).[hydrocortisone ]
5.Dose: [100]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAVENOUS
9.Start Date: Feb/8/2021
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902264
Page 57 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Ongoing? NO
End Date:
Feb/8/2021
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902265
Page 58 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[2]
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).[paclitaxel]
5.Dose: [138]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAVENOUS
9.Start Date: Feb/8/2021
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902266
Page 59 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Ongoing? NO
End Date:
Feb/8/2021
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902267
Page 60 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902268
Page 61 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902269
Page 62 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. DELETED OTHER
Specify:
paclitaxel
Feb/8/2021 Repeating Pages
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902270
Page 63 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
1.Transfusion Type: OTHER
Specify:
[paclitaxel ]
2.Date of Transfusion: Feb/8/2021
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902271
Page 64 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902272
Page 65 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902273
Page 66 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902274
Page 67 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902275
Page 68 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902276
Page 69 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902277
Page 70 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902278
Page 71 of 200
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902279
Page 72 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/10/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902280
Page 73 of 200
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902281
Page 74 of 200
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902282
Page 75 of 200
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902283
Page 76 of 200
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902284
Page 77 of 200
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902285
Page 78 of 200
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902286
Page 79 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/14/2020
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902287
Page 80 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902288
Page 81 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Lillestol Approved Mar-09-2021 16:50:27 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902289
Page 82 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-26-2020 12:59:45 (UTC-06:00)
Central Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902290
Page 83 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Lillestol Approved Mar-09-2021 16:50:27 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Mar-08-2021 08:35:19 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Feb-23-2021 13:11:29 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902291
Page 84 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, MichaelLillestol, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-17-2021 10:38:49 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Feb-12-2021 12:21:26 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902292
Page 85 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Feb-10-2021 11:03:56 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Oct-22-2020 17:32:25 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902293
Page 86 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-26-2020
12:58:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-26-2020
12:58:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902294
Page 87 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020
12:59:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/26/2020Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902295
Page 88 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020
12:58:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10281059Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-17-2020
07:52:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse satisfies query
Oct-16-2020
11:38:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answeredthis was submitted
yesterday
Oct-16-2020
04:25:10
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Reissued:
OpenedSAE RECON 1: Date of
birth is a required
information for
reconciliation. Per latest
SAE listing the date of
birth is still missing.Please
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902296
Page 89 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
submit a follow up AEM
form to update the safety
database
Oct-15-2020
09:57:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answeredit was not required int he
forms I submitted.
Oct-15-2020
05:02:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
OpenedSAE
RECON:AER#2020398901
,the date of birth was
missing in Safety database
but was recorded as
/1972 in AE
CRF.Please confirm if date
of birth was reported.If
safety update is required,
please submit a follow-up
form
Aug-26-2020
12:58:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Ent
ry:
/19
72Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020
12:59:25
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902297
Page 90 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020
12:59:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020
12:59:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902298
Page 91 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020
12:59:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902299
Page 92 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-26-2020
13:00:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020
13:00:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020
13:00:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902300
Page 93 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-26-2020
13:20:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Anxiety
Start Date
:Aug/UNK
/2016
Ongoing: NO
End Date
:
Nov/U
NK/20
16Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:20:46
(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:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902301
Page 94 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-26-2020
13:20:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-26-2020
13:20:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-26-2020
13:20:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/UNK/2016Initial Entry
1.b
Date Location User Value Reason
Aug-26-2020
13:21:04
(UTC-06:00)
Central Time (USACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902302
Page 95 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada) Medical
History T
erm:Asthma, A
llergy Indu
ced
Start Date
:UNK/UN
K/1992
Ongoing: YES
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902303
Page 96 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
13:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Asthma, Allergy Ind
ucedInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-26-2020
13:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-26-2020
13:21:04ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902304
Page 97 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.c
Date Location User Value Reason
Aug-26-2020
13:21:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:GERD
Start Date
:UNK/UN
K/2016
Ongoing: NO
End Date
:
UNK/U
NK/201
7Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902305
Page 98 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:21:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
13:21:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-26-2020
13:21:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-26-2020
13:21:18ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902306
Page 99 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2017
1.d
Date Location User Value Reason
Aug-26-2020
13:21:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Hyperlip
idemia
Start Date: UNK/U
NK/201
5
Ongoing: YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902307
Page 100 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:21:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
13:21:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-26-2020
13:21:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-26-2020
13:21:31ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902308
Page 101 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.e
Date Location User Value Reason
Aug-26-2020
13:21:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Hypothy
roidism
Start Date: Aug/30/
2019
Ongoing: YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902309
Page 102 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:21:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
13:21:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HypothyroidismInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-26-2020
13:21:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/30/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-26-2020
13:21:54ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902310
Page 103 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.f
Date Location User Value Reason
Aug-26-2020
13:22:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical
History T
erm:Polycystic
Ovarian Di
sease
Start Dat
e:UNK/UN
K/2003
Ongoing: YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902311
Page 104 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:22:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
13:22:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Polycystic Ovarian D
iseaseInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-26-2020
13:22:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-26-2020
13:22:14ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902312
Page 105 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.g
Date Location User Value Reason
Aug-26-2020
13:22:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical Hi
story Term:Seasonal
Allergies
Start Date: UNK/U
NK/1985
Ongoing: YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902313
Page 106 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:22:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
13:22:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-26-2020
13:22:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-26-2020
13:22:28ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902314
Page 107 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.h
Date Location User Value Reason
Aug-26-2020
13:23:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical
History T
erm:Wisdom Te
eth Extracti
on
Start Dat
e:UNK/UNK/
1994
Ongoing: NO
End Date:
UNK/U
NK/199
4Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902315
Page 108 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:23:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
13:23:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Wisdom Teeth Extrac
tionInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-26-2020
13:23:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1994Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-26-2020
13:23:00ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902316
Page 109 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/1994
1.i
Date Location User Value Reason
Aug-26-2020
13:23:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical Hi
story Term
:Amoxicil
lin Allerg
y
Start Date: UNK/UN
K/1992
Ongoing: YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0902317
Page 110 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:23:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
13:23:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Amoxicillin AllergyInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-26-2020
13:23:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-26-2020
13:23:19ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902318
Page 111 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.j
Date Location User Value Reason
Aug-26-2020
13:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:Ceftin A
llergy
Start Date: UNK/U
NK/199
8
Ongoing: YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902319
Page 112 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Aug-26-2020
13:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020
13:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Ceftin AllergyInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-26-2020
13:23:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-26-2020
13:23:43ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902320
Page 113 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902321
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
150.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902322
Page 115 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
64.75Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.2Initial Entry
7.a
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.1Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902323
Page 116 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902324
Page 117 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Aug-26-2020
13:03:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902325
Page 118 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-26-2020
13:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-26-2020
13:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-26-2020
13:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902326
Page 119 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-26-2020
13:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-26-2020
13:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-26-2020
13:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902327
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-26-2020
13:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-26-2020
13:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-26-2020
13:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902328
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020
13:04:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020
13:04:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
66525Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0902329
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020
08:41:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020
08:41:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
08:41:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-27-2020
08:41:07
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902330
Page 123 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-27-2020
08:41:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020
08:41:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BN61G
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020
08:41:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN61GJInitial Entry
5.b
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902331
Page 124 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-27-2020
08:41:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN61G
KInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020
08:41:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN61GKInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020
08:42:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BN61G
LInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902332
Page 125 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Aug-27-2020
08:42:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN61GLInitial Entry
5.d
Date Location User Value Reason
Aug-27-2020
08:43:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BLBC1
PInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-27-2020
08:43:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLBC1PInitial Entry
5.e
Date Location User Value Reason
Aug-27-2020
08:43:09ACV0PFEINFP6000 Data Entry:
Sample ID BLBC1Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0902333
Page 126 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada): R
5.e Sample ID
Date Location User Value Reason
Aug-27-2020
08:43:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLBC1RInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902334
Page 127 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020
08:43:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020
08:43:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
08:43:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-27-2020
08:43:18
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902335
Page 128 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-27-2020
08:43:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020
08:43:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BN61F
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020
08:43:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN61FGInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902336
Page 129 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-26-2020
13:04:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020
13:04:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020
13:04:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902337
Page 130 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-26-2020
13:04:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020 10:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020
13:04:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-26-2020
13:04:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-26-2020
13:04:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902338
Page 131 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020
13:04:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-26-2020
13:04:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902339
Page 132 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-26-2020
13:04:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902340
Page 133 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020
01:33:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Per site
confirmation
Oct-05-2020
12:33:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered patient
reported
diarrhea and
no other
symptoms.
reviewed with
investigator
and patient did
not need to
swab at that
time.
Oct-04-2020
02:43:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened As per Illness
ediary records,
subject
reported "Yes"
for the
question "Have
you
experienced
any of the
following?” for
the COVID-19
symptoms or
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902341
Page 134 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
diagnosis on
02SEP2020.
But there is no
COVID Illness
visit reported
in the database.
Please clarify.
Sep-16-2020
14:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902342
Page 135 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020
14:04:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020
14:04:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperatu
re:98.2
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020
14:04:44
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902343
Page 136 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-16-2020
14:04:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020
14:04:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020
14:04:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902344
Page 137 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020
14:04:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-16-2020
14:04:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020
14:04:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902345
Page 138 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-16-2020
14:04:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-16-2020
14:04:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-16-2020
14:04:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902346
Page 139 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-16-2020
14:04:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020
14:04:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-16-2020
14:04:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902347
Page 140 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
14:04:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
14:04:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020
14:05:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
14:04:58
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902348
Page 141 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-16-2020
14:04:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
13:20:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP92M
8Transcription
Error
Sep-16-2020
14:05:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP92M
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
13:20:13
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
BP92M8Transcription
Error
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902349
Page 142 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)
Sep-16-2020
14:05:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP92MBInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902350
Page 143 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-16-2020
14:05:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020
14:05:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020
14:05:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902351
Page 144 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-16-2020
14:05:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020 10:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020
14:05:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020
14:05:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020
14:05:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902352
Page 145 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-16-2020
14:05:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-16-2020
14:05:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902353
Page 146 of 200
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
16:35:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902354
Page 147 of 200
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
16:36:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
16:36:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
16:36:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
16:36:11
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902355
Page 148 of 200
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
16:36:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
16:36:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR8ZY
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
16:36:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR8ZYLInitial Entry
5.b
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902356
Page 149 of 200
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-14-2020
16:37:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR8ZY
MInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
16:37:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR8ZYMInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020
16:37:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR8ZY
NInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902357
Page 150 of 200
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
16:37:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR8ZYNInitial Entry
5.d
Date Location User Value Reason
Oct-14-2020
16:37:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLBCG
LInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-14-2020
16:37:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLBCGLInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902358
Page 151 of 200
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020
14:41:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020
14:41:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020
14:41:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902359
Page 152 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902360
Page 153 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902361
Page 154 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902362
Page 155 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902363
Page 156 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
diarrheaInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902364
Page 157 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/1/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-05-2020
10:34:20
(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).
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902365
Page 158 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902366
Page 159 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902367
Page 160 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-05-2020
10:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902368
Page 161 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020
10:49:28
(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
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
invasive ductal carci
noma stage 1B, left b
reastInitial Entry
4. Start Date Time:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902369
Page 162 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020
14:42:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Transcription
Error
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902370
Page 163 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-15-2020
04:47:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Answer Auto
Query
Oct-15-2020
01:54:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissue
d:Candidatepending sdb
update
Oct-14-2020
13:53:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000
)Query 1: Answere
dthis was faxed
this morning
Oct-14-2020
06:02:50
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:invasive
ductal carcinoma
stage 1B,left
breast(Onset
date:30Sep2020)
is not reported to
Safety database
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902371
Page 164 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
but marked
serious on AE
CRF.Confirm
seriousness and
report to Pfizer
immediately.If
this event is not
serious,
downgrade the
event on AE
CRF
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
teFor AE invasive
ductal carcinoma
stage 1B, left
breast: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is
blank.
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious ev
ent associated w
ith congenital an
omaly or birth d
efect?
NO
Did this serious
event result in dInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902372
Page 165 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eath?
NO
Did this serious
event require or
prolong hospital
ization?
NO
Did this serious
event result in p
ersistent or signi
ficant disability/
incapacity?
NO
Is this serious ev
ent life threateni
ng?
NO
Other medically
important seriou
s 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.
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902373
Page 166 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-13-2020
10:49:28
(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
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify:
breast cancerInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902374
Page 167 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-09-2021
09:47:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Per Site: No
further
information
available at this
time
Mar-08-2021
15:21:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dpatient was
possibly
receiving
further
treatment. will
request
additional
records.
Mar-08-2021
14:25:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
OpenedGPDCLIN;
thanks you for
updating
concomitant
medication to
yes. Per
PROHIB CM
page, chemo
was given only
on Feb 8th.
please confirm
this is correct
or update
PROHIB CM
log as
applicable.
Mar-08-2021 ACV0PFEINFP6000 auto query Query 1: Answere Changed
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902375
Page 168 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
08:35:19
(UTC-06:00)
Central Time (US
& Canada)(autoquery) d Information
Mar-08-2021
08:35:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESChanged
Information
Mar-08-2021
03:45:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN:
Concomitant
medication is
listed as NO
however,
chemotherapy
is reported on
PROHIB CM
page. please
review and
calrify.
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020
10:49:28
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902376
Page 169 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED
/NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020
10:49:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-15-2020
04:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2020398901Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902377
Page 170 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
left breast lumpInitial Entry
4. Start Date Time:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902378
Page 171 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/29/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020
10:55:14
(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
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902379
Page 172 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902380
Page 173 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
breast lump
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020
10:55:14
(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
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902381
Page 174 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020
10:55:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902382
Page 175 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-19-2020
19:45:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-16-2020
11:39:14ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902383
Page 176 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
Oct-16-2020
11:39:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
left arm soreness at
injection site.Changed
Information
Oct-15-2020
20:21:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery:
left arm
soreness -
please confirm
if at site of
study
injection, if so
please update
entry to
include 'at
injection site'
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
left arm sorenessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
Aug/27/2020 UNK:
UNKInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902384
Page 177 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/29/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-13-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0902385
Page 178 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10:58:16
(UTC-06:00)
Central Time (US
& Canada)NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902386
Page 179 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-13-2020
10:58:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020
10:58:16ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0902387
Page 180 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902388
Page 181 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-22-2021
14:51:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Deleted New
Information
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902389
Page 182 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902390
Page 183 of 200
***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, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CORTICOSTEROID
SInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902391
Page 184 of 200
***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, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
Feb-24-2021
12:51:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-22-2021
14:51:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dit was entered
because even
though it's not
14 days, it was
given in a way
that isn't
allowed per
protocol. will
remove
Feb-22-2021
13:23:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Hydrocortisone
is reported
ONCE on
08FEB2021. As
this
corticosteroid
was not taken
for 14 days,
please verify it
is not a
prohibited
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902392
Page 185 of 200
***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, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
medication per
section 6.5.1 of
the protocol.
Therefore,
please verify it
was entered in
error.
Feb-17-2021
10:38:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
hydrocortisoneTranscription
Error
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
hydrocortisonInitial Entry
5. Dose:
Date Location User Value Reason
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
100Initial Entry
6. Dose Unit:
Date Location User Value Reason
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902393
Page 186 of 200
***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, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ONCEInitial Entry
8. Route:
Date Location User Value Reason
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
INTRAVENOUSInitial Entry
9. Start Date:
Date Location User Value Reason
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
Feb/8/2021Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902394
Page 187 of 200
***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, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
& Canada)
10. Ongoing?
Date Location User Value Reason
Feb-17-2021
10:38:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Feb/8/2021Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902395
Page 188 of 200
***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, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CONCOMITANT I
MMUNOSUPPRES
SIVE THERAPYInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-18-2021
15:01:50
(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
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0902396
Page 189 of 200
***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, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
paclitaxelInitial Entry
5. Dose:
Date Location User Value Reason
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
138Initial Entry
6. Dose Unit:
Date Location User Value Reason
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902397
Page 190 of 200
***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, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ONCEInitial Entry
8. Route:
Date Location User Value Reason
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
INTRAVENOUSInitial Entry
9. Start Date:
Date Location User Value Reason
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021Initial Entry
10. Ongoing?
Date Location User Value Reason
Feb-18-2021
15:01:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Feb/8/2021Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902398
Page 191 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-22-2021
10:46:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Feb-17-2021
10:39:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902399
Page 192 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Transfusion Type:
Date Location User Value Reason
Feb-17-2021
10:39:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OTHER
Specify:
paclitaxelInitial Entry
2. Date of Transfusion:
Date Location User Value Reason
Feb-23-2021
10:49:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-22-2021
10:45:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answe
redChanged data per
query
Feb-19-2021
14:06:59
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
LiauQuery 1: Reissu
ed:OpenedGPD CLIN: Please
remove
chemotherapy from
transfusion record
since this is
documented
appropriately on
the prohibited
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0902400
Page 193 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
immunosuppressant
CRF.
Feb-18-2021
15:02:01
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answe
redupdated
Feb-18-2021
11:39:59
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opene
dGPDCLIN: Please
record paclitaxel on
the PROHIB CM
page.
Feb-17-2021
10:39:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0902401
Page 194 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
11:03:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902402
Page 195 of 200
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-05-2021
13:28:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissu
ed:Candidatepatient has breast
cancer and
undergoing
immunosuppresive
therapy. will get
her back in once
she is eligible.
Mar-05-2021
11:03:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answ
eredpatient has breast
cancer and
undergoing
immunosuppresive
therapy. will get
her back in once
she is eligible
Mar-05-2021
06:45:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opene
dDM: Participant is
eligible and
confirmed to have
received Placebo,
but Date Written
Consent Obtained
is missing in
Informed Consent
- Further
Vaccination CRF.
Please review and
update as
appropriate.
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902403
Page 196 of 200
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-10-2021
11:04:28
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Delete
dClose Auto Query
Feb-10-2021
11:04:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candi
dateThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Feb-10-2021
11:04:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is w
illing to return f
or Vaccination
3
Participant is:
eligible per l
ocal/national
recommenda
tions and co
nfirmed to h
ave received
only placebo
at Vaccinatio
n 1/2Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902404
Page 197 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-10-2021
11:04:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-10-2021
11:04:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902405
Page 198 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-15-2020
14:41:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-26-2020
13:04:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-26-2020
13:00:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-15-2020
14:41:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Aug-26-2020
13:04:06ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902406
Page 199 of 200
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
Aug-26-2020
13:00:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902407
Page 200 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020
09:10:07
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090177e196ae3e0d\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902408