Document text
Page 1 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903131
Page 2 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Oct/27/2020
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903132
Page 3 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10281283]
2.Birth Date: 1951
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903133
Page 4 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903134
Page 5 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903135
Page 6 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903136
Page 7 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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:[codeine allergy]
Start Date: UNK/UNK/1956
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[supraventricular tachycardia]
Start Date: Jan/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[benign prostatic hyperplasia]
Start Date: UNK/UNK/2017
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral carotid artery stenosis]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903137
Page 8 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral cataracts]
Start Date: UNK/UNK/2016
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic back pain]
Start Date: UNK/UNK/1977
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastroesophageal reflux disease]
Start Date: UNK/UNK/2017
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[herpes simplex labialis]
Start Date: UNK/UNK/2013
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903138
Page 9 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[impaired fasting glucose]
Start Date: UNK/UNK/2015
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/2016
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[colonoscopy]
Start Date: Mar/8/2013
Ongoing: NO
End Date:
Mar/8/2013
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903139
Page 10 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[colon polypectomy benign]
Start Date: Mar/8/2013
Ongoing: NO
End Date:
Mar/8/2013
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[colonoscopy]
Start Date: Jul/28/2018
Ongoing: NO
End Date:
Jul/28/2018
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[colon polypectomy benign]
Start Date: Jul/28/2018
Ongoing: NO
End Date:
Jul/28/2018
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vasectomy]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903140
Page 11 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right renal cyst]
Start Date: UNK/UNK/2017
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left hand tendon repair]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left hand laceration]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bicep tendon repair left]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903141
Page 12 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left bicep injury]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[overweight]
Start Date: UNK/UNK/2015
Ongoing: YES
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[paresthesia bilateral feet]
Start Date: UNK/UNK/2015
Ongoing: YES
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic kidney disease stage 2]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903142
Page 13 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903143
Page 14 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
2.Weight: [165.0]
3.Unit: LB
4.Height: [66.14]
5.Unit: in
6.Body Mass Index: [26.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903144
Page 15 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/27/2020
2.Randomization Number: [272647]
3.Randomization Group: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903145
Page 16 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR90BH]
5.bSample ID [BR90BJ]
5.cSample ID [BR90BK]
5.dSample ID [BLBCL6]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903146
Page 17 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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:
Oct/27/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR907K]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903147
Page 18 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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: Oct/27/2020 12:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903148
Page 19 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903149
Page 20 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903150
Page 21 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903151
Page 22 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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:
Nov/17/2020
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 [BRJ69S]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903152
Page 23 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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: Nov/17/2020 13:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903153
Page 24 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903154
Page 25 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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:
Dec/15/2020
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 [BRCG8W]
5.bSample ID [BRCG8X]
5.cSample ID [BRCG8Y]
5.dSample ID [BMNMJ7]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903155
Page 26 of 191
***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: 10281283 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:
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903156
Page 27 of 191
***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: 10281283 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: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903157
Page 28 of 191
***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: 10281283 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 [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903158
Page 29 of 191
***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: 10281283 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 [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903159
Page 30 of 191
***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: 10281283 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?
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903160
Page 31 of 191
***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: 10281283 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:
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903161
Page 32 of 191
***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: 10281283 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:
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903162
Page 33 of 191
***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: 10281283 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 [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903163
Page 34 of 191
***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: 10281283 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:
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903164
Page 35 of 191
***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: 10281283 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 [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903165
Page 36 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
1.ADVERSE E
VENT 1 atrial fibrillation with rapid ve
ntricular response Feb/16/2021 19:
00 NO
End Date Time:
Feb/17/2021 UNK:U
NK
Repeating
Pages
2.ADVERSE E
VENT 2 acute kidney injury Feb/16/2021 21:
14 NO
End Date Time:
Feb/23/2021 12:20
Repeating
Pages
3.ADVERSE E
VENT 3 atrial fibrillation Feb/16/2021 U
NK:UNK YES Repeating
Pages
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903166
Page 37 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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)[atrial fibrillation with rapid ventricular response]
4.Start Date Time: Feb/16/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/17/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903167
Page 38 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[atrial fibrillation]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021240848]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903168
Page 39 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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)[acute kidney injury]
4.Start Date Time: Feb/16/2021 21:14
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/23/2021 12:20
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[dehydration]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903169
Page 40 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903170
Page 41 of 191
***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: 10281283 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)[atrial fibrillation]
4.Start Date Time: Feb/16/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[atrial fibrillation]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903171
Page 42 of 191
***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: 10281283 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?: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[ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903172
Page 43 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903173
Page 44 of 191
***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: 10281283 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[ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903174
Page 45 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903175
Page 46 of 191
***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: 10281283 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: //
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903176
Page 47 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903177
Page 48 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903178
Page 49 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903179
Page 50 of 191
***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: 10281283 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?
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903180
Page 51 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903181
Page 52 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903182
Page 53 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903183
Page 54 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903184
Page 55 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903185
Page 56 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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:
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903186
Page 57 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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?
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903187
Page 58 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903188
Page 59 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903189
Page 60 of 191
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903190
Page 61 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903191
Page 62 of 191
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903192
Page 63 of 191
***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: 10281283 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: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903193
Page 64 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903194
Page 65 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/14/2021
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903195
Page 66 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903196
Page 67 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/14/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903197
Page 68 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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:
Jan/14/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR4YX5]
5.bSample ID [BR4YX6]
5.cSample ID [BR4YX7]
5.dSample ID [BMNMLZ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903198
Page 69 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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:
Jan/14/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR4YWM]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903199
Page 70 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/14/2021 09:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903200
Page 71 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903201
Page 72 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903202
Page 73 of 191
***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: 10281283 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: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903203
Page 74 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903204
Page 75 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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:
Feb/4/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR4Z12]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903205
Page 76 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/4/2021 10:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903206
Page 77 of 191
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: 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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903207
Page 78 of 191
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/4/2021
3.Comments: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903208
Page 79 of 191
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903209
Page 80 of 191
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903210
Page 81 of 191
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903211
Page 82 of 191
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903212
Page 83 of 191
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/4/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903213
Page 84 of 191
***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: 10281283 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 Dec/15/2020
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903214
Page 85 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10281283 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
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903215
Page 86 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10281283 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-11-2021 12:45:36 (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.
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903216
Page 87 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-28-2020 10:37:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903217
Page 88 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-14-2021 13:11:29 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903218
Page 89 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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-11-2021 12:45:36 (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-10-2021 09:32:22 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Mar-09-2021 17:06:52 (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-04-2021 16:21:23 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903219
Page 90 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Michael
Lillestol Approved Feb-12-2021 13:07:28 (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 Feb-04-2021 11:56:54 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Jan-21-2021 12:39:17 (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 Jan-14-2021 13:11:15 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Jan-13-2021 12:54:13 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903220
Page 91 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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 Jan-12-2021 09:12:41 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Dec-18-2020 17:37:55 (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 Dec-15-2020 18:08:22 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Nov-30-2020 13:23:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903221
Page 92 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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.
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903222
Page 93 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Oct-28-2020 10:36:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-28-2020 10:36:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903223
Page 94 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-28-2020 10:36:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/27/2020Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903224
Page 95 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-28-2020 10:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10281283Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-28-2020 10:32:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-28-2020 10:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-28-2020 10:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-28-2020 10:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903225
Page 96 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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-28-2020 10:37:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903226
Page 97 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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-28-2020 10:38:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 10:38:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 10:38:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903227
Page 98 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Oct-28-2020 11:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:codeine allerg
y
Start Date: UNK/UNK/1
956
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
codeine allergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-28-2020 11:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1956Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-28-2020 11:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0b\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-2021-5683-0903228
Page 99 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b
Date Location User Value Reason
Oct-28-2020 11:03:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:supraventricular t
achycardia
Start Date: Jan/UNK/2020
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:03:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:03:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
supraventricular tachycardiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-28-2020 11:03:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-28-2020 11:03:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3e0b\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-2021-5683-0903229
Page 100 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-28-2020 11:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histo
ry Term:benign prostatic h
yperplasia
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:03:39
(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
Oct-28-2020 11:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
benign prostatic hyperplasiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-28-2020 11:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-28-2020 11:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-28-2020 11:03:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4Initial Entry
090177e196ae3e0b\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-2021-5683-0903230
Page 101 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histo
ry Term:bilateral carotid ar
tery stenosis
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903231
Page 102 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:03:58
(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
Nov-01-2020 02:29:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-30-2020 13:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered confirmed mild. no
intervention
required at this
time. Did not meet
exclusion criteria 1
Oct-30-2020 08:39:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: Please
clarify the severity
of carotid stenosis
and if intervention
is indicated. Please
also confirm that
exclusion criterion
#1 was NOT met.
Oct-28-2020 11:03:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
bilateral carotid artery stenosisInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-28-2020 11:03:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-28-2020 11:03:58
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0b\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),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0903232
Page 103 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
1.e
Date Location User Value Reason
Oct-28-2020 11:04:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:bilateral catar
acts
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:04:14
(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
Oct-28-2020 11:04:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
bilateral cataractsInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-28-2020 11:04:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-28-2020 11:04:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0b\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-2021-5683-0903233
Page 104 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f
Date Location User Value Reason
Oct-28-2020 11:06:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:chronic back
pain
Start Date: UNK/UNK/1
977
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:06:16
(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
Oct-28-2020 11:06:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
chronic back painInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-28-2020 11:06:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1977Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-28-2020 11:06:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
090177e196ae3e0b\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-2021-5683-0903234
Page 105 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-28-2020 11:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:gastroesophageal r
eflux disease
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
gastroesophageal reflux diseaseInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-28-2020 11:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-28-2020 11:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-28-2020 11:08:20 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e0b\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-2021-5683-0903235
Page 106 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Numb
er:8
Medical History
Term:herpes simplex
labialis
Start Date: UNK/UNK/201
3
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:08:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:08:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
herpes simplex labialisInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-28-2020 11:08:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-28-2020 11:08:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-28-2020 11:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:9Initial Entry
090177e196ae3e0b\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-2021-5683-0903236
Page 107 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History T
erm:hyperlipidemi
a
Start Date: UNK/UNK/2
018
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hyperlipidemiaInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-28-2020 11:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-28-2020 11:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Oct-28-2020 11:08:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:hypertensionInitial Entry
090177e196ae3e0b\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-2021-5683-0903237
Page 108 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/2
010
Ongoing: YES
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903238
Page 109 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:08:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:08:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-28-2020 11:08:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-28-2020 11:08:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Oct-28-2020 11:09:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:impaired fasting
glucose
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
090177e196ae3e0b\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-2021-5683-0903239
Page 110 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:09:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:09:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
impaired fasting glucoseInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-28-2020 11:09:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-28-2020 11:09:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Oct-28-2020 11:09:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:12
Medical History T
erm:osteoarthritis
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae3e0b\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-2021-5683-0903240
Page 111 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:09:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:09:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
osteoarthritisInitial Entry
1.l Start Date:
Date Location User Value Reason
Oct-28-2020 11:09:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.l Ongoing:
Date Location User Value Reason
Oct-28-2020 11:09:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Oct-28-2020 11:10:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Te
rm:colonoscopy
Start Date: Mar/8/2013
Ongoing: NO
End Date:
Mar/8/20
13Initial Entry
090177e196ae3e0b\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-2021-5683-0903241
Page 112 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:10:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:10:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
colonoscopyInitial Entry
1.m Start Date:
Date Location User Value Reason
Oct-28-2020 11:10:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2013Initial Entry
1.m Ongoing:
Date Location User Value Reason
Oct-28-2020 11:10:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/8/2013Initial Entry
1.n
Date Location User Value Reason
Mar-10-2021 09:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:14
Medical Hist
ory Term:colon polypecto
my benign
Start Date: Mar/8/2013Transcription Error
090177e196ae3e0b\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-2021-5683-0903242
Page 113 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
Mar/8/2013
Oct-28-2020 11:10:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:14
Medical Hist
ory Term:colon polypecto
my benign
Start Date: Mar/3/2013
Ongoing: NO
End Date:
Mar/3/2013Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903243
Page 114 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:10:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:10:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
colon polypectomy benignInitial Entry
1.n Start Date:
Date Location User Value Reason
Mar-10-2021 09:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2013Transcription Error
Oct-28-2020 11:10:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/3/2013Initial Entry
1.n Ongoing:
Date Location User Value Reason
Mar-11-2021 02:51:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-10-2021 09:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Mar-10-2021 09:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/8/2013Transcription Error
Mar-10-2021 00:15:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: End
date is 3Mar2013
while colonoscopy
090177e196ae3e0b\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), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0903244
Page 115 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
date is 8Mar2013.
please consider
reconciling the
dates or else, please
clarify.
Mar-09-2021 10:07:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate GPDCLIN: End
date is 3Mar2013
while colonoscopy
date is 8Mar2013.
please consider
reconciling the
dates or else, please
clarify.
Oct-28-2020 11:10:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/3/2013Initial Entry
1.o
Date Location User Value Reason
Oct-28-2020 11:11:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 15
Medical History Te
rm:colonoscopy
Start Date: Jul/28/2018
Ongoing: NO
End Date:
Jul/28/20
18Initial Entry
090177e196ae3e0b\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-2021-5683-0903245
Page 116 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.o Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:11:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:11:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
colonoscopyInitial Entry
1.o Start Date:
Date Location User Value Reason
Oct-28-2020 11:11:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/28/2018Initial Entry
1.o Ongoing:
Date Location User Value Reason
Oct-28-2020 11:11:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/28/2018Initial Entry
1.p
Date Location User Value Reason
Oct-28-2020 11:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:16
Medical Histo
ry Term:colon polypectom
y benign
Start Date: Jul/28/2018Initial Entry
090177e196ae3e0b\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-2021-5683-0903246
Page 117 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
Jul/28/2018
1.p Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
colon polypectomy benignInitial Entry
1.p Start Date:
Date Location User Value Reason
Oct-28-2020 11:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/28/2018Initial Entry
1.p Ongoing:
Date Location User Value Reason
Oct-28-2020 11:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/28/2018Initial Entry
1.q
Date Location User Value Reason
Oct-28-2020 11:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:17Initial Entry
090177e196ae3e0b\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-2021-5683-0903247
Page 118 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History
Term:vasectomy
Start Date: UNK/UNK/199
0
Ongoing: NO
End Date:
UNK/UNK/
1990
1.q Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
vasectomyInitial Entry
1.q Start Date:
Date Location User Value Reason
Oct-28-2020 11:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.q Ongoing:
Date Location User Value Reason
Oct-28-2020 11:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.r
Date Location User Value Reason
090177e196ae3e0b\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-2021-5683-0903248
Page 119 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-28-2020 11:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:18
Medical History T
erm:right renal cy
st
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
1.r Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
right renal cystInitial Entry
1.r Start Date:
Date Location User Value Reason
Oct-28-2020 11:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0903249
Page 120 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.r Ongoing:
Date Location User Value Reason
Oct-28-2020 11:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Oct-28-2020 11:16:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:19
Medical Histor
y Term:left hand tendon
repair
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/2
013Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0903250
Page 121 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.s Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:16:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:16:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
left hand tendon repairInitial Entry
1.s Start Date:
Date Location User Value Reason
Oct-28-2020 11:16:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.s Ongoing:
Date Location User Value Reason
Oct-28-2020 11:16:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.t
Date Location User Value Reason
Oct-28-2020 11:16:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:20
Medical History
Term:left hand lacera
tion
Start Date: UNK/UNK/201
3Initial Entry
090177e196ae3e0b\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-2021-5683-0903251
Page 122 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/
2013
1.t Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:16:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:16:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
left hand lacerationInitial Entry
1.t Start Date:
Date Location User Value Reason
Oct-28-2020 11:16:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.t Ongoing:
Date Location User Value Reason
Oct-28-2020 11:16:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.u
Date Location User Value Reason
Oct-28-2020 11:17:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:21Initial Entry
090177e196ae3e0b\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-2021-5683-0903252
Page 123 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histor
y Term:bicep tendon rep
air left
Start Date: UNK/UNK/200
5
Ongoing: NO
End Date:
UNK/UNK/2
005
1.u Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:17:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:17:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
bicep tendon repair leftInitial Entry
1.u Start Date:
Date Location User Value Reason
Oct-28-2020 11:17:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.u Ongoing:
Date Location User Value Reason
Oct-28-2020 11:17:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.v
Date Location User Value Reason
090177e196ae3e0b\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-2021-5683-0903253
Page 124 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-28-2020 11:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:22
Medical History
Term:left bicep injury
Start Date: UNK/UNK/200
5
Ongoing: NO
End Date:
UNK/UNK/
2005Initial Entry
1.v Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
left bicep injuryInitial Entry
1.v Start Date:
Date Location User Value Reason
Oct-28-2020 11:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.v Ongoing:
Date Location User Value Reason
Oct-28-2020 11:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
090177e196ae3e0b\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-2021-5683-0903254
Page 125 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.w
Date Location User Value Reason
Oct-28-2020 11:17:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:23
Medical History T
erm:overweight
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.w Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:17:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:17:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
overweightInitial Entry
1.w Start Date:
Date Location User Value Reason
Oct-28-2020 11:17:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.w Ongoing:
Date Location User Value Reason
Oct-28-2020 11:17:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.x
090177e196ae3e0b\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-2021-5683-0903255
Page 126 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-28-2020 11:17:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:24
Medical Histor
y Term:paresthesia bilat
eral feet
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
1.x Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:17:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:17:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
paresthesia bilateral feetInitial Entry
1.x Start Date:
Date Location User Value Reason
Oct-28-2020 11:17:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.x Ongoing:
Date Location User Value Reason
Oct-28-2020 11:17:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.y
Date Location User Value Reason
090177e196ae3e0b\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-2021-5683-0903256
Page 127 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-05-2021 11:17:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:25
Medical Histo
ry Term:chronic kidney dis
ease stage 2
Start Date: UNK/UNK/2014
Ongoing: YESInitial Entry
1.y Line/MH Number:
Date Location User Value Reason
Mar-05-2021 11:17:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-05-2021 11:17:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
chronic kidney disease stage 2Initial Entry
1.y Start Date:
Date Location User Value Reason
Mar-05-2021 11:17:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.y Ongoing:
Date Location User Value Reason
Mar-05-2021 11:17:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0b\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-2021-5683-0903257
Page 128 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-28-2020 10:38:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903258
Page 129 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
165.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
66.14Initial Entry
5. Unit:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26.5Initial Entry
090177e196ae3e0b\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)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0903259
Page 130 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 97.9
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-28-2020 10:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e0b\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)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0903260
Page 131 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-28-2020 10:39:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-28-2020 10:39:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
272647Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903261
Page 132 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 10:42:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 10:42:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 10:47:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 10:42:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-28-2020 10:42:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020 10:47:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR90BHInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903262
Page 133 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 10:47:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR90BHInitial Entry
5.b
Date Location User Value Reason
Oct-28-2020 10:47:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR90BJInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 10:47:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR90BJInitial Entry
5.c
Date Location User Value Reason
Oct-28-2020 10:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR90BKInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 10:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR90BKInitial Entry
5.d
Date Location User Value Reason
Oct-28-2020 10:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBCL6Initial Entry
090177e196ae3e0b\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),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0903263
Page 134 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Oct-28-2020 10:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLBCL6Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903264
Page 135 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 10:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 10:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 10:48:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 10:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-28-2020 10:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020 10:48:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR907KInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903265
Page 136 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 10:48:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR907KInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0903266
Page 137 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Oct-28-2020 10:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-28-2020 10:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-28-2020 10:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-28-2020 10:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 12:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-28-2020 10:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-28-2020 10:48:30
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e0b\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-2021-5683-0903267
Page 138 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-28-2020 10:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-28-2020 10:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-28-2020 10:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0903268
Page 139 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Oct-28-2020 10:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903269
Page 140 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-17-2020 15:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903270
Page 141 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-17-2020 15:08:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
2.a
Date Location User Value Reason
Nov-17-2020 15:08:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 98.1
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-17-2020 15:08:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-17-2020 15:08:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-17-2020 15:08:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e0b\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)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0903271
Page 142 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature Location:
Date Location User Value Reason
Nov-17-2020 15:08:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903272
Page 143 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-17-2020 15:08:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-17-2020 15:08:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020 15:08:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-17-2020 15:08:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-17-2020 15:08:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/17/2020Initial Entry
5.a
Date Location User Value Reason
Nov-17-2020 15:08:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJ69SInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903273
Page 144 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Nov-17-2020 15:08:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRJ69SInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903274
Page 145 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Nov-17-2020 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-17-2020 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-17-2020 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-17-2020 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020 13:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-17-2020 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-17-2020 15:09:03
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e0b\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-2021-5683-0903275
Page 146 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Nov-17-2020 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-17-2020 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-17-2020 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903276
Page 147 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-15-2020 18:08:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000
)Data Entry:
Dec/15/2020Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903277
Page 148 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-15-2020 18:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-15-2020 18:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-15-2020 18:08:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-15-2020 18:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-15-2020 18:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/15/2020Initial Entry
5.a
Date Location User Value Reason
Dec-15-2020 18:08:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCG8WInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903278
Page 149 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Dec-15-2020 18:08:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCG8WInitial Entry
5.b
Date Location User Value Reason
Dec-15-2020 18:08:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCG8XInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-15-2020 18:08:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCG8XInitial Entry
5.c
Date Location User Value Reason
Dec-15-2020 18:09:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCG8YInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-15-2020 18:09:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCG8YInitial Entry
5.d
Date Location User Value Reason
Dec-15-2020 18:09:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNMJ7Initial Entry
090177e196ae3e0b\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),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903279
Page 150 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Dec-15-2020 18:09:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNMJ7Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903280
Page 151 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903281
Page 152 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903282
Page 153 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903283
Page 154 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021 16:21:23
(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
Mar-08-2021 07:56:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed SAE event term is
now A Fib with
RVR
Mar-05-2021 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - Event
term is A Fib with
RVR; however, SAE
(#2021240848) is A
Fib. Please review,
harmonize
reporting, and
update where
appropriate
Mar-05-2021 08:58:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
atrial fibrillation with rapid ven
tricular responseNew Information
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
atrial fibrillationInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3e0b\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-2021-5683-0903284
Page 155 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-05-2021 11:59:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021 19:00Changed
Information
Mar-04-2021 16:24:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-04-2021 16:24:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-04-2021 16:24:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021 UNK:UNKTranscription Error
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For atrial
fibrillation: Start
date 16/Feb/2020 is
before V1D1VX1L
visit date 27/Oct
/2020. Please
review and update
as appropriate.
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start date is before
Consent Date
27/Oct/2020.
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021 07:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed SAE event dates
submitted
Mar-05-2021 15:10:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical - please
submit SAE start
and end dates as a
SAE report update,
in the Event section
under START and
STOP
090177e196ae3e0b\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903285
Page 156 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-04-2021 16:24:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-04-2021 16:24:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/17/2021 UNK:UNKTranscription Error
Mar-04-2021 16:24:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For atrial
fibrillation End
Date & Time
17/Feb/2020
UNK:UNK is
before the Start
Date & Time
16/Feb/2021
UNK:UNK.
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/17/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021 16:21:23
(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
Mar-07-2021 23:02:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3e0b\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-2021-5683-0903286
Page 157 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-05-2021 08:58:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE atrial
fibrillation with
rapid ventricular
response: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE atrial
fibrillation:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
NOInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903287
Page 158 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021 16:21:23
(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
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
atrial fibrillationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae3e0b\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-2021-5683-0903288
Page 159 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-04-2021 16:21:23
(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
Mar-04-2021 16:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021 16:21:23
(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
Mar-07-2021 23:02:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021240848Initial Entry
090177e196ae3e0b\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-2021-5683-0903289
Page 160 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021 11:58:17
(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
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
acute kidney injuryInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021 21:14Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/23/2021 12:20Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e0b\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-2021-5683-0903290
Page 161 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-05-2021 11:58:17
(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
Mar-05-2021 11:58:17
(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
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-09-2021 09:36:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-09-2021 08:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered this is what the PI
thought it could be
attributed to, but
dehydration is not
in the medical
record for this
instance and was
not reported by the
patient.
Mar-08-2021 18:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened clinical: please
clarify, when did
the dehydration
090177e196ae3e0b\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), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0903291
Page 162 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
start?
Mar-08-2021 15:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered this is not a new
AE
Mar-08-2021 12:15:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: if
dehydration is a
new clinical event,
please add to CRF
as AE. Thanks
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
dehydrationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3e0b\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),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0903292
Page 163 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-05-2021 11:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903293
Page 164 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021 12:00:36
(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
Mar-09-2021 09:25:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-09-2021 08:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered atrial fibrillation is
a new diagnosis.
Mar-08-2021 18:03:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened clinical: pls clarify
response, are you
saying this is a new
diagnosis?
Mar-08-2021 15:21:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Mar-08-2021 12:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls
confirm this is a
new diagnosis.
Thanks
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
atrial fibrillationInitial Entry
090177e196ae3e0b\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), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903294
Page 165 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Start Date Time:
Date Location User Value Reason
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021 12:00:36
(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
Mar-05-2021 12:00:36
(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
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3e0b\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903295
Page 166 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
atrial fibrillationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021 12:00:36
(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
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3e0b\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903296
Page 167 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-05-2021 12:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903297
Page 168 of 191
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Dec-15-2020 18:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-15-2020 18:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-15-2020 18:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903298
Page 169 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021 09:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Changed
Information
Jan-12-2021 09:12:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021New Information
Dec-16-2020 16:49:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
090177e196ae3e0b\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-2021-5683-0903299
Page 170 of 191
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Jan-12-2021 09:13:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-12-2021 09:13:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-12-2021 09:13:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirme
d to have received only place
bo at Vaccination 1/2New Information
Dec-16-2020 16:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to ret
urn for Vaccination 3 OR other
wise not eligibleInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903300
Page 171 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021 13:11:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903301
Page 172 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-14-2021 13:11:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/14/2021Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903302
Page 173 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Jan-14-2021 13:11:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-14-2021 13:11:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-14-2021 13:11:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903303
Page 174 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-14-2021 13:11:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-14-2021 13:11:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-14-2021 13:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-14-2021 13:11:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-14-2021 13:11:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Jan-14-2021 13:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR4YX5Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903304
Page 175 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Jan-14-2021 13:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR4YX5Initial Entry
5.b
Date Location User Value Reason
Jan-14-2021 13:12:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR4YX6Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-14-2021 13:12:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR4YX6Initial Entry
5.c
Date Location User Value Reason
Jan-14-2021 13:12:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR4YX7Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-14-2021 13:12:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR4YX7Initial Entry
5.d
Date Location User Value Reason
Jan-14-2021 13:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNMLZInitial Entry
090177e196ae3e0b\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),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903305
Page 176 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User ValueReason
Jan-18-2021
14:26:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Jan-18-2021
08:35:32
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dOriginal value is
correct
Jan-15-2021
05:08:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6843037;The
barcode BMNMLZ is
recorded for two
subjects 10281267
and 10281283. Please
review and update as
appropriate.
Jan-14-2021
13:12:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
BMN
MLZInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0903306
Page 177 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-14-2021 13:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-14-2021 13:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-14-2021 13:23:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-14-2021 13:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-14-2021 13:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Jan-14-2021 13:23:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR4YWMInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903307
Page 178 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Jan-14-2021 13:23:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR4YWMInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903308
Page 179 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021 09:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e0b\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-2021-5683-0903309
Page 180 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-14-2021 13:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903310
Page 181 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-12-2021 09:13:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-12-2021 09:13:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903311
Page 182 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10281283 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-04-2021 11:56:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903312
Page 183 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 11:57:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 11:57:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 11:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 11:57:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-04-2021 11:57:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021 11:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR4Z12Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903313
Page 184 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 11:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR4Z12Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903314
Page 185 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021 10:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e0b\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-2021-5683-0903315
Page 186 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-04-2021 11:57:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0903316
Page 187 of 191
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: 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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 16:24:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/4/2021Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903317
Page 188 of 191
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-04-2021 16:26:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-04-2021 16:26:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Mar/4/2021Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903318
Page 189 of 191
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 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
Mar-04-2021 16:26:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/4/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-04-2021 16:26:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-04-2021 16:26:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903319
Page 190 of 191
***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: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-15-2020 18:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-28-2020 10:39:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-28-2020 10:38:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-15-2020 18:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/15/2020Initial Entry
Oct-28-2020 10:39:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Oct-28-2020 10:38:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903320
Page 191 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281283 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-30-2020 11:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e0b\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903321