125742 S1 M5 CRF c4591001 1197 11971097

Document text

Page 1 of 195
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949844
Page 2 of 195
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/19/2020
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949845
Page 3 of 195
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [11971097]
2.Birth Date: UNK/UNK/1948
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:
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949846
Page 4 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949847
Page 5 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949848
Page 6 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949849
Page 7 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diabetes mellitus type 2]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperuricemia]
Start Date: Jan/8/1998
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypercholesterolemia]
Start Date: Jan/8/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[renal insufficiency]
Start Date: Sep/26/2010
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anemia]
Start Date: Oct/9/2014
Ongoing: YES
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949850
Page 8 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arterial hypertension]
Start Date: Sep/10/2003
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coxarthrosis left hip]
Start Date: Mar/22/2017
Ongoing: YES
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949851
Page 9 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949852
Page 10 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
2.Weight: [65.9]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [22.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949853
Page 11 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/19/2020
2.Randomization Number: [270700]
3.Randomization Group: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949854
Page 12 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BN8NZX]
5.bSample ID [BN8NZY]
5.cSample ID [BNM3YZ]
5.dSample ID [BNM3Z0]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949855
Page 13 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BN8NZD]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949856
Page 14 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/19/2020 16:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949857
Page 15 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949858
Page 16 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/7/2020
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949859
Page 17 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949860
Page 18 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949861
Page 19 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949862
Page 20 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/7/2020
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 [BN8P3K]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949863
Page 21 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/7/2020 15:27
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
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949864
Page 22 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/5/2020
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949865
Page 23 of 195
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949866
Page 24 of 195
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949867
Page 25 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/5/2020
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 [BN8PB4]
5.bSample ID [BN8PB5]
5.cSample ID [BNLMK6]
5.dSample ID [BNLMK7]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949868
Page 26 of 195
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949869
Page 27 of 195
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949870
Page 28 of 195
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949871
Page 29 of 195
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949872
Page 30 of 195
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949873
Page 31 of 195
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949874
Page 32 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949875
Page 33 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949876
Page 34 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949877
Page 35 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949878
Page 36 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Acute Posterior Myocardial I
nfarction Jan/3/2021 14:
30 NO
End Date Time:
Jan/8/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Arm Swelling  Feb/13/2021 1
8:00 NO
End Date Time:
Feb/14/2021 16:00
 Repeating
Pages
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949879
Page 37 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[Acute Posterior Myocardial Infarction]
4.Start Date Time: Jan/3/2021 14:30
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/8/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[arterial hypertension, hypercholesterolemia, diabetes mellitus type 2]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949880
Page 38 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?: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[2021006704]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949881
Page 39 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[Arm Swelling]
4.Start Date Time: Feb/13/2021 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/14/2021 16:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949882
Page 40 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949883
Page 41 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949884
Page 42 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949885
Page 43 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart Da
teForm Instanc
e
 1.1  VACCINATIONS  NO  fluzone 0.7 ml i.
m Dec/7/20
20 Repeating
Pages
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949886
Page 44 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[fluzone 0.7 ml i.m]
5.Date: Dec/7/2020
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949887
Page 45 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949888
Page 46 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949889
Page 47 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949890
Page 48 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949891
Page 49 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949892
Page 50 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949893
Page 51 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949894
Page 52 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949895
Page 53 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949896
Page 54 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949897
Page 55 of 195
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949898
Page 56 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949899
Page 57 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949900
Page 58 of 195
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949901
Page 59 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949902
Page 60 of 195
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949903
Page 61 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949904
Page 62 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949905
Page 63 of 195
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949906
Page 64 of 195
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949907
Page 65 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/13/2021
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949908
Page 66 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/12/2021
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949909
Page 67 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949910
Page 68 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/13/2021 Comments
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949911
Page 69 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [BN0PDX]
5.bSample ID [BN0PDC]
5.cSample ID [BNMXZ9]
5.dSample ID [BNLMG2]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949912
Page 70 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [BN0PDB]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949913
Page 71 of 195
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO Comments
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/13/2021 11:03
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
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949914
Page 72 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949915
Page 73 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
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 [BN0PGR]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949916
Page 74 of 195
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Mar/5/2021 13:36
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
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949917
Page 75 of 195
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949918
Page 76 of 195
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949919
Page 77 of 195
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949920
Page 78 of 195
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949921
Page 79 of 195
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949922
Page 80 of 195
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949923
Page 81 of 195
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949924
Page 82 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/5/2020
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949925
Page 83 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949926
Page 84 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Matthias
Luttermann Approved Mar-08-2021 22:18:22 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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.
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949927
Page 85 of 195
***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, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-19-2020 18:05:15 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949928
Page 86 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-13-2021 11:54:41 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949929
Page 87 of 195
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-19-2021 15:47:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebLars Pohlmeier sate correct, vaccination delay due to temperature
excursion and delayed decision for use of
vaccination IP
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949930
Page 88 of 195
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-19-2021 20:45:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebLars Pohlmeier no IP available for vaccination due to delayed
arrival of IP
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949931
Page 89 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Matthias
Luttermann Approved Mar-08-2021 22:18:22 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-08-2021 12:06:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Mar-05-2021 22:59:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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-05-2021 12:09:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Feb-22-2021 21:30:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949932
Page 90 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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.
Matthias
Luttermann N/A Feb-22-2021 21:16:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Lars Pohlmeier  Approved Feb-19-2021 20:46:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, LarsPohlmeier, 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.
Lars Pohlmeier  N/A Feb-19-2021 20:44:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Lars Pohlmeier  Approved Feb-19-2021 16:24:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, LarsPohlmeier, 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.
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949933
Page 91 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Lars Pohlmeier  N/A Feb-19-2021 15:47:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Feb-18-2021 22:24:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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-18-2021 13:37:14 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Feb-15-2021 17:02:54 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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-12-2021 14:12:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Feb-09-2021 01:02:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949934
Page 92 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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.
Matthias
Luttermann N/A Feb-09-2021 00:55:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Jan-25-2021 22:43:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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.
Matthias
Luttermann N/A Jan-25-2021 18:00:42 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Jan-17-2021 21:29:35 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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.
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949935
Page 93 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Matthias
Luttermann N/A Jan-17-2021 21:27:18 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Jan-12-2021 22:33:14 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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.
Matthias
Luttermann N/A Jan-12-2021 22:28:20 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Jan-08-2021 22:49:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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-08-2021 12:52:01 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Jan-05-2021 23:25:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949936
Page 94 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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-05-2021 11:23:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Dec-07-2020 19:47:18 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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-07-2020 11:37:14 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Dec-05-2020 15:14:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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.
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949937
Page 95 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Dec-05-2020 11:30:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Nov-08-2020 22:44:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-07-2020 14:49:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Nov-03-2020 16:54:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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 Oct-31-2020 12:31:42 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Matthias
Luttermann Approved Oct-30-2020 10:43:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949938
Page 96 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, MatthiasLuttermann, 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.
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949939
Page 97 of 195
***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, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-19-2020 18:04:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-19-2020 18:04:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949940
Page 98 of 195
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-19-2020 18:04:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/19/2020Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949941
Page 99 of 195
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-19-2020 18:04:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11971097Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-19-2020 18:04:02
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
UNK/UNK/1948Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-19-2020 18:04:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-19-2020 18:04:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  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-19-2020 18:04:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949942
Page 100 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 18:05:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949943
Page 101 of 195
***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, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-19-2020 18:05:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 18:05:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 18:05:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949944
Page 102 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Oct-19-2020 18:38:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:diabetes mellitus
type 2
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:38:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 18:38:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
diabetes mellitus type 2Initial Entry
1.a Start Date:
Date Location User Value Reason
Oct-19-2020 18:38:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-19-2020 18:38:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949945
Page 103 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-19-2020 18:39:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:hyperuricemi
a
Start Date: Jan/8/1998
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:39:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 18:39:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
hyperuricemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-19-2020 18:39:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Jan/8/1998Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-19-2020 18:39:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-19-2020 18:39:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:hypercholesterol
emia
Start Date: Jan/8/2020Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949946
Page 104 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:39:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 18:39:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
hypercholesterolemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-19-2020 18:39:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Jan/8/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-19-2020 18:39:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-19-2020 18:40:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:renal insufficie
ncy
Start Date: Sep/26/2010
Ongoing: YESInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949947
Page 105 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.d Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:40:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 15:42:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-20-2020 19:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Answered stable disease under
control
Oct-20-2020 19:33:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Opened medical history reports
a number of serious
ongoing conditions (
renal insufficiency,
hypertension,diabetes):
please confirm that
they are all controlled
and stable and that the
patient fulfils inclusion
criterion 3.
Oct-19-2020 18:40:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
renal insufficiencyInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-19-2020 18:40:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sep/26/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-19-2020 18:40:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0949948
Page 106 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.e
Date Location User Value Reason
Oct-19-2020 18:41:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Term: anemia
Start Date: Oct/9/2014
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:41:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 18:41:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
anemiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-19-2020 18:41:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/9/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-19-2020 18:41:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-19-2020 18:41:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949949
Page 107 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Medical History T
erm:arterial hyperten
sion
Start Date: Sep/10/2003
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:41:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 18:41:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
arterial hypertensionInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-19-2020 18:41:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sep/10/2003Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-19-2020 18:41:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-31-2020 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:7
Medical History
Term:Coxarthrosis l
eft hip
Start Date: Mar/22/2017
Ongoing: YESChanged
Information
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949950
Page 108 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-29-2020 22:01:18
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:insertion of endop
rothesis left hip
Start Date: Mar/22/2017
Ongoing: YESChanged
Information
Oct-20-2020 00:03:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry:
Line/MH Numb
er:7
Medical Histor
y Term:endoprothesis l
eft hip
Start Date: Mar/22/2017
Ongoing: YESChanged
Information
Oct-19-2020 18:43:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:endoprothetic l
eft hip
Start Date: Mar/22/2017
Ongoing: YESInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949951
Page 109 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.g Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:43:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-31-2020
12:31:42
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Data En
try:
Coxarthr
osis left
hipChanged
Information
Oct-30-2020
05:49:38
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 2:
ClosedDiscrepancy has
been closed.
Oct-29-2020
22:01:18
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  auto query (autoquery) Query 2:
Answere
dChanged
Information
Oct-29-2020
22:01:18
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Matthias Luttermann Data En
try:
insertion
of endop
rothesis l
eft hipChanged
Information
Oct-29-2020
18:30:23
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query 2:
Reissued
:OpenedPlease update the
term to reflect the
query response of
"Insertion of
Prosthesis."
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949952
Page 110 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-26-2020
09:02:44
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query 2:
Answere
dInsertion of
Prosthesis is correct
Oct-25-2020
16:11:10
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Saumitra Dubey TMS
QueryQuery 2:
Reissued
:OpenedCoding Query:
Thanks for the
response. Coding of
the verbatim can not
happen with
existing term.
Kindly update the
term and add
insertion of
prosthesis OR
update the term as
suggested
previously.
Oct-20-2020
14:54:26
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query 2:
Answere
dEndoprothesis Left
Hip was necessary
due to Coxarthrosis
left Hip
Oct-20-2020
11:45:57
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 2:
OpenedClarify
ENDOPROTHESIS
LEFT HIP as
follows...Device
only term. Are you
reporting
INSERTION?
REMOVAL?
INFECTION OF?
COMPLICATION
WITH? If so,
update the verbatim
term as such.
Otherwise clarify
and edit the term.
Thank you.
Oct-20-2020
07:37:07
(UTC+01:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1:
ClosedDiscrepancy has
been closed.
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949953
Page 111 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sarajevo,
Skopje,
Warsaw,
Zagreb
Oct-20-2020
00:03:12
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  auto query (autoquery) Query 1:
Answere
dChanged
Information
Oct-20-2020
00:03:12
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Matthias Luttermann Data En
try:
endoprot
hesis left
hipChanged
Information
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949954
Page 112 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
23:51:53
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Ope
nedClarify
ENDOPROTHETIC
LEFT HIP as
follows...Device
only reported. Are
you reporting
INSERTION?
REMOVAL?
INFECTION OF? Or
other? Please update
the verbatim term to
further specify.
Thank you.
Oct-19-2020
18:43:07
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
endoprothetic
left hipInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-19-2020 18:43:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Mar/22/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Nov-02-2020 12:18:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-31-2020 12:32:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Answered Query was updated
Oct-30-2020 16:29:23
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Opened no term coding
reported for this
condition
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949955
Page 113 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-19-2020 18:43:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949956
Page 114 of 195
***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, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-19-2020 18:08:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949957
Page 115 of 195
***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, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
65.9Initial Entry
3. Unit:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
170.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.8Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0949958
Page 116 of 195
***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, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.a
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-19-2020 18:08:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0949959
Page 117 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-19-2020 18:44:00
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-19-2020 18:44:00
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
270700Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949960
Page 118 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 18:09:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 18:09:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 18:45:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 18:09:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-19-2020 18:09:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 18:45:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8NZXInitial Entry
5.a Sample ID
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949961
Page 119 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-19-2020 18:45:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8NZXInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020 18:45:53
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8NZYInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 18:45:53
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8NZYInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 18:46:17
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNM3YZInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 18:46:17
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNM3YZInitial Entry
5.d
Date Location User Value Reason
Oct-19-2020 18:46:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNM3Z0Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0949962
Page 120 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Oct-19-2020 18:46:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNM3Z0Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949963
Page 121 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 18:09:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 18:09:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 18:46:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 18:09:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-19-2020 18:09:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 18:46:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8NZDInitial Entry
5.a Sample ID
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949964
Page 122 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-19-2020 18:46:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8NZDInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949965
Page 123 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-19-2020 18:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020 18:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020 18:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 18:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/19/2020 16:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020 18:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-19-2020 18:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949966
Page 124 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Oct-19-2020 18:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020 18:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-19-2020 18:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949967
Page 125 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-19-2020 18:10:37
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS SU
BJECTInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949968
Page 126 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020 15:50:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Nov/7/2020Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949969
Page 127 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIG
UEInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0949970
Page 128 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949971
Page 129 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0949972
Page 130 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949973
Page 131 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0949974
Page 132 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949975
Page 133 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949976
Page 134 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 15:51:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0949977
Page 135 of 195
***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, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-07-2020 15:52:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Nov/7/2020Initial Entry
2.a
Date Location User Value Reason
Nov-07-2020 15:52:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-07-2020 15:52:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-07-2020 15:52:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-07-2020 15:52:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0949978
Page 136 of 195
***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, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-07-2020 15:52:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949979
Page 137 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-07-2020 14:49:04
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-07-2020 14:49:04
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-07-2020 14:49:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-07-2020 14:49:04
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Nov-07-2020 14:49:04
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/7/2020Initial Entry
5.a
Date Location User Value Reason
Nov-07-2020 14:49:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8P3KInitial Entry
5.a Sample ID
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949980
Page 138 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-07-2020 14:49:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8P3KInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949981
Page 139 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-07-2020 15:53:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-07-2020 15:53:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-07-2020 15:53:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-07-2020 15:53:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Nov/7/2020 15:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-07-2020 15:53:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-07-2020 15:53:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949982
Page 140 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Nov-07-2020 15:53:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-07-2020 15:53:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-07-2020 15:59:23
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949983
Page 141 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-05-2020 11:30:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Dec/5/2020Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949984
Page 142 of 195
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949985
Page 143 of 195
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NO
2.b Symptom:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949986
Page 144 of 195
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic symp
toms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949987
Page 145 of 195
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949988
Page 146 of 195
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949989
Page 147 of 195
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949990
Page 148 of 195
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949991
Page 149 of 195
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJE
CTION
SITE
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 11:31:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949992
Page 150 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-05-2020 12:55:48
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-05-2020 12:55:48
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-05-2020 12:55:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-05-2020 12:55:48
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Dec-05-2020 12:55:48
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/5/2020Initial Entry
5.a
Date Location User Value Reason
Dec-05-2020 12:55:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8PB4Initial Entry
5.a Sample ID
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949993
Page 151 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-05-2020 12:55:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8PB4Initial Entry
5.b
Date Location User Value Reason
Dec-05-2020 12:56:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8PB5Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-05-2020 12:56:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8PB5Initial Entry
5.c
Date Location User Value Reason
Dec-05-2020 12:56:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNLMK6Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-05-2020 12:56:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNLMK6Initial Entry
5.d
Date Location User Value Reason
Dec-05-2020 12:56:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNLMK7Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949994
Page 152 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Dec-05-2020 12:56:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNLMK7Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0949995
Page 153 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0949996
Page 154 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0949997
Page 155 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-19-2021 16:35:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle Castillo Query 3: Closed OK
Feb-15-2021 12:53:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 3: Answered Update was done
Feb-10-2021 21:03:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle Castillo Query 3: Reissued:Opened An update has not
been noted. Escalated
to CRA
Feb-04-2021 12:27:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 3: Answered Follow up reports
were sent to Pfizer
Drug Safety Unit
Feb-01-2021 17:32:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle Castillo Query 3: Reissued:Opened thanks for your
response. No FU form
has been submitted
and information has nt
been updated. Kindly
clarify.
Jan-26-2021 07:15:00
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 3: Answered done
Jan-26-2021 01:31:39
(UTC+01:00) Sarajevo,ACV0PFEINFP6000  Giselle Castillo Query 3: Reissued:Opened Thanks for clarifying.
Please provide this
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949998
Page 156 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Skopje, Warsaw, Zagreb information in a FU
form so it is added to
the safety report
Jan-25-2021 09:32:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 3: Answered Pharynxsmear for
Coronar PCR
Jan-24-2021 16:44:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle Castillo Query 3: Reissued:Opened Answer is not clear.
Pls clarify information
on safety report
("culture was
negative"). Was this
result from a urine,
blood or other type of
culture? Thank you.
Jan-20-2021 16:20:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 3: Answered throat swab was taken
in the hospital
Jan-20-2021 00:39:53
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle Castillo Query 3: Opened Per report
AER#2021006704,
the subject had a
"culture was
negative". Pls clarify
if this was a urine,
blood or other type of
culture. Thanks.
Jan-15-2021 00:40:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle Castillo Query 2: Closed Thank you for the
prompt response.
Jan-12-2021 14:52:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 2: Answered done
Jan-10-2021 17:44:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle Castillo Query 2: Opened Per report, "The
subject underwent lab
tests and procedures…
and therapeutic
measures were taken".
However, this
information is missing
on safety report,
kindly provide details
on relevant lab tests
(including covid
testing) and tx in a FU
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949999
Page 157 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
form. Thanks
Jan-08-2021 14:13:43
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-07-2021 23:54:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannQuery 1: Answered No prior Cardiac
disease
Jan-06-2021 15:36:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Opened clinical: pls advise if
subject has any known
prior cardiac disease.
Thanks
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Acute Posterior Myocardial Infa
rctionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Jan/3/2021 14:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-17-2021 21:28:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry:
NO
End Date Time:
Jan/8/2021 UNK:UNKChanged
Information
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0950000
Page 158 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
Jan-08-2021 12:53:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-07-2021 23:54:06
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannQuery 2: Answered Already done and
confirmed
Jan-06-2021 13:21:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 2: Opened SAE RECON:Acute
Posterior Myocardial
Infarction(Onset
date:03Jan2021) is
not reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Jan-06-2021 04:28:06
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Acute
Posterior Myocardial
Infarction: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950001
Page 159 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
YES
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
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-13-2021 18:05:06
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-12-2021 22:28:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Jan-12-2021 22:28:20
(UTC+01:00) Sarajevo,ACV0PFEINFP6000  Matthias
LuttermannData Entry:
NOT RELATEDChanged Information
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0950002
Page 160 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Skopje, Warsaw, Zagreb If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
arterial hypertension, hyp
ercholesterolemia, diabete
s mellitus type 2
Jan-12-2021 22:05:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Reissued:Opened I suggest to mention
the known risk factors
under OTHER causes
Jan-12-2021 16:36:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Reissued:Candidate I suggest to mention
the known risk factors
under OTHER causes
Jan-12-2021 14:27:48
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Answered Positive Family
History for Coronary
Heart Disease and
Diabetes Mellitus Typ
II as positive Risk
Factor
Jan-11-2021 15:38:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Opened please report the most
probable cause of this
MI: of note patient's
medical history was
positive for important
risk factors , as
hypertension,
hypercholesterolemia,
diabetes.
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Acute DiseaseInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950003
Page 161 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-18-2021
06:44:00
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 2: Closed Response satisfies query
Jan-17-2021
21:27:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed Information
Jan-17-2021
21:27:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry:
RECOVERED/RESO
LVEDChanged Information
Jan-17-2021
11:52:35
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 2: Reissued:Op
enedSAE RECON 2: Outcome was
recorded as
RECOVERING/RESOLVING in
AE CRF. Please confirm if this
should be updated to
recovered/resolved per previous
query response (The Patient
recovered 08 Jan 2021).
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0950004
Page 162 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-15-2021
10:10:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Lars Pohlmeier Query 2: Answered The Patient recovered 08 Jan 2021
Jan-13-2021
11:24:50
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 2: Reissued:Op
enedSAE RECON 1: Outcome was
updated to
RECOVERED/RESOLVED in
Safety database however, recorded
as RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Jan-12-2021
17:43:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 2: Answered done
Jan-11-2021
10:53:30
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2021006704,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950005
Page 163 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-06-2021
04:30:19
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1
: Close
dAuto closed by
Validation Check:
VC_AE001_35
Jan-05-2021
23:22:51
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1
: Answ
eredChanged Information
Jan-05-2021
23:22:51
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Matthias Luttermann Data E
ntry:
RECO
VERIN
G/RES
OLVIN
GChanged Information
Jan-05-2021
16:17:16
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1
: Opene
dDMW6700250;Response
to "What was the
outcome of this adverse
event?" is
'Recovered/Resolved' or
'Recovered/Resolved
with Sequelae' but End
Date/Time is missing.
Please review and update
as appropriate.
Jan-05-2021
11:23:47
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Data E
ntry:
RECO
VERE
D/RES
OLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950006
Page 164 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-05-2021 11:23:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-08-2021 12:52:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
2021006704Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0950007
Page 165 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  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 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Arm SwellingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Feb/13/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/14/2021 16:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021 12:22:28 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0950008
Page 166 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb1
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 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  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 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0950009
Page 167 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-05-2021 12:31:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-05-2021 12:31:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDChanged Information
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Arm Swelling:
Response to "What was
the outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-05-2021 12:22:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0950010
Page 168 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-07-2020 11:37:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0950011
Page 169 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Dec-07-2020 11:37:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Dec-07-2020 11:37:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Dec-07-2020 11:37:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter the
full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Dec-07-2020 11:37:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
fluzone 0.7 ml i mInitial Entry
5. Date:
Date Location User Value Reason
Dec-07-2020 11:37:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Dec/7/2020Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0950012
Page 170 of 195
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-05-2020 11:31:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Dec/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-05-2020 11:31:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-05-2020 11:31:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0950013
Page 171 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021 18:00:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry:
Jan/25/2021Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950014
Page 172 of 195
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-09-2021 00:55:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per other protocol allo
wance(s) and confirmed to ha
ve received only placebo at V
accination 1/2Transcription Error
Jan-25-2021 18:01:18
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-25-2021 18:00:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  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-25-2021 18:00:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950015
Page 173 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-25-2021 18:01:18
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-25-2021 18:01:18
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950016
Page 174 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-13-2021 11:52:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Feb/13/2021Changed Information
Feb-12-2021 14:12:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0950017
Page 175 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-15-2021 05:31:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-13-2021 11:57:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Answered Due to
TemperatureExcursion
of IP Product
Vaccination Day was
13/Feb/2021
Feb-13-2021 11:54:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date Informed Consent
Obtained is not the
same as the Date of
Visit. Please correct as
necessary.
Feb-13-2021 11:54:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/12/2021Initial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0950018
Page 176 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Mar-08-2021
15:49:00
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Mar-08-2021
12:06:36
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  auto query
(autoquery)Query
2: Ans
weredChanged Information
Mar-08-2021
12:06:36
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Data
Entry
:
Feb/1
3/202
1Changed Information
Mar-08-2021
06:54:27
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dDM : Form unfrozen.
Please review and update.
Else, clarify.
Mar-05-2021
22:56:22
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Matthias Luttermann Query
2: Ans
weredCorrect date should be
13-FEB-2021, but cannot be
changed; frozen?
Mar-05-2021
11:13:00
(UTC+01:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW7607873;Date of
Completion/Discontinuation
/Death on Disposition
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950019
Page 177 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sarajevo,
Skopje,
Warsaw,
ZagrebScreening for Further
Vaccination is not equal to
Date of Visit in the same
visit. Please review and
update as appropriate.
Feb-22-2021
07:33:25
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Feb-19-2021
20:46:10
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Lars Pohlmeier Query
1: Ans
weredSee comment
Feb-19-2021
20:37:37
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM: Was there a temporary
delay of vaccination? is
recorded as "No" on
vaccination form. Please
review and update if there
was a delay in vaccination.
Feb-19-2021
15:47:53
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Lars Pohlmeier Query
1: Ans
weredChanged data per query
Feb-19-2021
11:26:37
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM: Thank you for
response. Since there was a
vaccination delay, Kindly
consider to update the
response for temporary
delay of vaccination on the
vaccination form. Else
clarify.
Feb-18-2021
22:16:44ACV0PFEINFP6000  Matthias Luttermann Query
1: Ansdate correct, vaccination
delay because of
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950020
Page 178 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
Zagrebweredtemperature excursion and
time costing process to
release vaccination from
quarantine
Feb-18-2021
09:05:29
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Balaji Prabu R Query
1: Op
enedDate is reported as
12Feb2021, but subject
received vaccination on
13Feb2021. Please confirm
the date is correct as entered
or update if necessary.
Otherwise clarify. Thank
you.
Feb-12-2021
14:13:31
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Data
Entry
:
Feb/1
2/202
1Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-12-2021 14:13:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-18-2021 22:17:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-18-2021 13:37:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status"
is COMPLETED but
"Specify Status" is
Provided.
Feb-12-2021 14:13:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0950021
Page 179 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Feb-18-2021 22:17:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Matthias
LuttermannData Entry: Changed
Information
Feb-18-2021 13:37:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Data is correctInitial Entry
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950022
Page 180 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 14:48:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 14:48:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021
23:31:42
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 3: C
losedResponse satisfies
query
Feb-19-2021
09:36:41
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 3: A
nsweredDate of collection is
correct
Feb-19-2021
04:47:43
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw, ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 3: O
penedDMW7314605;Date
of Collection is not
equal to Date of
Visit. Please clarify
or correct.
Feb-16-2021
07:42:51
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 2: C
losedAs per site
confirmation -
updated PD tracker
090177e196ae3f1b\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0950023
Page 181 of 195
***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten
Drescher
Subject No: 11971097 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-15-2021
13:00:26
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 2: A
nswereddate confirmed
Feb-15-2021
09:51:13
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 2: O
penedPDQ: Date of
collection
12-Feb-2021 is not
equal to Date of
visit. Please review
and update the data
or else clarify.
Thanks.
Feb-12-2021
15:11:19
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw, Zagr
…[truncated]