Document text
Page 1 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948097
Page 2 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/16/2020
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948098
Page 3 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11951023]
2.Birth Date: UNK/UNK/1970
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:
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948099
Page 4 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948100
Page 5 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948101
Page 6 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948102
Page 7 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pollinosis]
Start Date: Jul/1/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety disorder]
Start Date: May/UNK/2001
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: Jan/UNK/2004
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Splay-flat feet]
Start Date: UNK/UNK/2002
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbal spine syndrome]
Start Date: Oct/13/2014
Ongoing: YES
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948103
Page 8 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteochondrosis]
Start Date: Apr/3/2001
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[fatty liver]
Start Date: Nov/21/2014
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[herniated disc cervical vertebra]
Start Date: Oct/5/2020
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[irritable bowel]
Start Date: Aug/24/2010
Ongoing: YES
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948104
Page 9 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948105
Page 10 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
2.Weight: [145.1]
3.Unit: kg
4.Height: [186.0]
5.Unit: cm
6.Body Mass Index: [41.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948106
Page 11 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/16/2020
2.Randomization Number: [108605]
3.Randomization Group: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948107
Page 12 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNMDG3]
5.bSample ID [BNMDG4]
5.cSample ID [BN8WWK]
5.dSample ID [BN8WWL]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948108
Page 13 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8WWH]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948109
Page 14 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/16/2020 08:17
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948110
Page 15 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948111
Page 16 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948112
Page 17 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948113
Page 18 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948114
Page 19 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Nov/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948115
Page 20 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
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 [BN86DD]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948116
Page 21 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/4/2020 08:05
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948117
Page 22 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/2/2020
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948118
Page 23 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948119
Page 24 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948120
Page 25 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/2/2020
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 [BNLWJS]
5.bSample ID [BNLWJT]
5.cSample ID [BN8KFZ]
5.dSample ID [BN8KG0]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948121
Page 26 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948122
Page 27 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/29/2020
2.Date of First Symptom Started: Oct/27/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/30/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? YES
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948123
Page 28 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948124
Page 29 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948125
Page 30 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948126
Page 31 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[no sample was collected. Patient came into our office]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948127
Page 32 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
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 [BN86CW]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948128
Page 33 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948129
Page 34 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948130
Page 35 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948131
Page 36 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Common cold]
Date of Diagnosis:
Oct/29/2020
3.Toxicity Grade: 2
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948132
Page 37 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948133
Page 38 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948134
Page 39 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for La
b TestVendor N
ameCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948135
Page 40 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948136
Page 41 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948137
Page 42 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948138
Page 43 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948139
Page 44 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948140
Page 45 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948141
Page 46 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948142
Page 47 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948143
Page 48 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948144
Page 49 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948145
Page 50 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948146
Page 51 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948147
Page 52 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948148
Page 53 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948149
Page 54 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948150
Page 55 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948151
Page 56 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948152
Page 57 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948153
Page 58 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
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).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948154
Page 59 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948155
Page 60 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948156
Page 61 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948157
Page 62 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/26/2021
2.Date of First Symptom Started: Feb/24/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948158
Page 63 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.aSymptoms - Other Text: [Inappetence]
5.bSymptoms - Other Text: [Nausea]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948159
Page 64 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948160
Page 65 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948161
Page 66 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[not necessary.Patient came into the office for a swab test.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948162
Page 67 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BN8L6N]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948163
Page 68 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948164
Page 69 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948165
Page 70 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948166
Page 71 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Gastroenteritis]
Date of Diagnosis:
Feb/26/2021
3.Toxicity Grade: 2
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948167
Page 72 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948168
Page 73 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948169
Page 74 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for La
b TestVendor N
ameCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948170
Page 75 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948171
Page 76 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948172
Page 77 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948173
Page 78 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948174
Page 79 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948175
Page 80 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948176
Page 81 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948177
Page 82 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948178
Page 83 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948179
Page 84 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948180
Page 85 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948181
Page 86 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948182
Page 87 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948183
Page 88 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948184
Page 89 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948185
Page 90 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948186
Page 91 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948187
Page 92 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948188
Page 93 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
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).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948189
Page 94 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948190
Page 95 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948191
Page 96 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/27/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/27/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948192
Page 97 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/27/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/27/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8KF1]
5.bSample ID [BN8KF2]
5.cSample ID [BNMDNV]
5.dSample ID [BNMDNT]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948193
Page 98 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948194
Page 99 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948195
Page 100 of 641
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 herniated disc cervical verteb
ra Nov/16/2020 UN
K:UNK NO
End Date Time:
Nov/20/2020 UNK:U
NK
Repeating
Pages
2.ADVERSE E
VENT 2 Pain at injection site Feb/20/2021 01:0
0 NO
End Date Time:
Feb/20/2021 17:00
Repeating
Pages
3.ADVERSE E
VENT 3 Vomiting Feb/20/2021 13:0
0 NO
End Date Time:
Feb/20/2021 22:00
Repeating
Pages
4.ADVERSE E
VENT 4 Diarrhoea Feb/20/2021 13:0
0 NO
End Date Time:
Feb/20/2021 22:00
Repeating
Pages
5.ADVERSE E
VENT 5 Redness injection site Feb/21/2021 09:3
0 NO
End Date Time:
Feb/27/2021 08:00
Repeating
Pages
6.ADVERSE E
VENT 6 worsening herniated disc cer
vical vertebra Jan/29/2021 UN
K:UNK YES Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948196
Page 101 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[herniated disc cervical vertebra]
4.Start Date Time: Nov/16/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/20/2020 UNK:UNK
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[surgery is necessary for diagnosed herniated disc on 05Oct2020]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948197
Page 102 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[2020448347]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948198
Page 103 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[Pain at injection site]
4.Start Date Time: Feb/20/2021 01:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/20/2021 17:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment: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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948199
Page 104 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948200
Page 105 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Vomiting]
4.Start Date Time: Feb/20/2021 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/20/2021 22:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment: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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948201
Page 106 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948202
Page 107 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diarrhoea]
4.Start Date Time: Feb/20/2021 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/20/2021 22:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment: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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948203
Page 108 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948204
Page 109 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Redness injection site]
4.Start Date Time: Feb/21/2021 09:30
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/27/2021 08:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment: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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948205
Page 110 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948206
Page 111 of 641
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[worsening herniated disc cervical vertebra]
4.Start Date Time: Jan/29/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[due to surgery at herniated cervical disc]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948207
Page 112 of 641
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948208
Page 113 of 641
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948209
Page 114 of 641
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948210
Page 115 of 641
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948211
Page 116 of 641
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948212
Page 117 of 641
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948213
Page 118 of 641
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948214
Page 119 of 641
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948215
Page 120 of 641
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948216
Page 121 of 641
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948217
Page 122 of 641
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948218
Page 123 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948219
Page 124 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948220
Page 125 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948221
Page 126 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948222
Page 127 of 641
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948223
Page 128 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948224
Page 129 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948225
Page 130 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948226
Page 131 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948227
Page 132 of 641
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948228
Page 133 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948229
Page 134 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/26/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948230
Page 135 of 641
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948231
Page 136 of 641
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948232
Page 137 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948233
Page 138 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/29/2021
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948234
Page 139 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948235
Page 140 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/29/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948236
Page 141 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BN8L05]
5.bSample ID [BN8L06]
5.cSample ID [BNLW9P]
5.dSample ID [BNLW9R]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948237
Page 142 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BN8L00]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948238
Page 143 of 641
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/29/2021 08:31
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948239
Page 144 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948240
Page 145 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/19/2021
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 [BN8L5W]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948241
Page 146 of 641
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/19/2021 08:22
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
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948242
Page 147 of 641
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948243
Page 148 of 641
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948244
Page 149 of 641
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948245
Page 150 of 641
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948246
Page 151 of 641
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948247
Page 152 of 641
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948248
Page 153 of 641
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948249
Page 154 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/2/2020
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948250
Page 155 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948251
Page 156 of 641
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Axel Schaefer Approved Mar-01-2021 19:23:41 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, 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.
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948252
Page 157 of 641
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-16-2020 12:35:14 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagrebn.a.
Not Applicable
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948253
Page 158 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948254
Page 159 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948255
Page 160 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948256
Page 161 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948257
Page 162 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948258
Page 163 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Oct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948259
Page 164 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Oct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948260
Page 165 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Oct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948261
Page 166 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Oct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948262
Page 167 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Oct-29-2020 08:45:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948263
Page 168 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 08:46:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948264
Page 169 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 08:46:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948265
Page 170 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-29-2020 08:46:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948266
Page 171 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-29-2020 08:46:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948267
Page 172 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-29-2020 08:46:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948268
Page 173 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Oct-29-2020 08:46:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948269
Page 174 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Oct-29-2020 08:46:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948270
Page 175 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 09:25:45 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948271
Page 176 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 09:25:45 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948272
Page 177 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-29-2020 09:25:45 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948273
Page 178 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-29-2020 09:25:45 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948274
Page 179 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-29-2020 09:25:45 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948275
Page 180 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948276
Page 181 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948277
Page 182 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948278
Page 183 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948279
Page 184 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948280
Page 185 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948281
Page 186 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948282
Page 187 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948283
Page 188 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948284
Page 189 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948285
Page 190 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948286
Page 191 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948287
Page 192 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948288
Page 193 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948289
Page 194 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948290
Page 195 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948291
Page 196 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948292
Page 197 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948293
Page 198 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948294
Page 199 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948295
Page 200 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948296
Page 201 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948297
Page 202 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948298
Page 203 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948299
Page 204 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948300
Page 205 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948301
Page 206 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948302
Page 207 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948303
Page 208 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948304
Page 209 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948305
Page 210 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948306
Page 211 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948307
Page 212 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-29-2020 09:26:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948308
Page 213 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948309
Page 214 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948310
Page 215 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948311
Page 216 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948312
Page 217 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948313
Page 218 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948314
Page 219 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948315
Page 220 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948316
Page 221 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948317
Page 222 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948318
Page 223 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948319
Page 224 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948320
Page 225 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948321
Page 226 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948322
Page 227 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948323
Page 228 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948324
Page 229 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948325
Page 230 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948326
Page 231 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948327
Page 232 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948328
Page 233 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948329
Page 234 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948330
Page 235 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948331
Page 236 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948332
Page 237 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948333
Page 238 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948334
Page 239 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948335
Page 240 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948336
Page 241 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948337
Page 242 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948338
Page 243 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948339
Page 244 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948340
Page 245 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948341
Page 246 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948342
Page 247 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948343
Page 248 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948344
Page 249 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948345
Page 250 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948346
Page 251 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948347
Page 252 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948348
Page 253 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948349
Page 254 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948350
Page 255 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948351
Page 256 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948352
Page 257 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jOct-29-2020 09:26:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948353
Page 258 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 09:26:51 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948354
Page 259 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 09:26:51 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948355
Page 260 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-29-2020 09:26:51 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948356
Page 261 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-29-2020 09:26:51 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948357
Page 262 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-29-2020 09:26:51 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948358
Page 263 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-29-2020 09:26:51 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948359
Page 264 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 09:27:07 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948360
Page 265 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 09:27:07 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948361
Page 266 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-29-2020 09:27:07 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948362
Page 267 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 09:27:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948363
Page 268 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 09:27:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948364
Page 269 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-29-2020 09:27:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948365
Page 270 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-29-2020 09:27:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948366
Page 271 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 09:28:10 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948367
Page 272 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 09:28:10 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948368
Page 273 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-29-2020 09:28:10 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948369
Page 274 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-29-2020 09:28:10 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948370
Page 275 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-29-2020 09:28:10 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948371
Page 276 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Oct-29-2020 09:28:10 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948372
Page 277 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Oct-29-2020 09:28:10 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948373
Page 278 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 09:28:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948374
Page 279 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-29-2020 09:28:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948375
Page 280 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-29-2020 09:28:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948376
Page 281 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-29-2020 09:28:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948377
Page 282 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-29-2020 09:28:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948378
Page 283 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-26-2021 09:38:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948379
Page 284 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-26-2021 09:38:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948380
Page 285 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-26-2021 09:38:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948381
Page 286 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-26-2021 09:38:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948382
Page 287 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-26-2021 09:38:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948383
Page 288 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-26-2021 09:38:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948384
Page 289 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-26-2021 09:38:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948385
Page 290 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Feb-26-2021 09:38:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9d\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948386
Page 291 of 641
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/26/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Feb-26-2021 09:38:56 (UTC+01:00) Sarajevo,
…[truncated]