Document text
Page 1 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947383
Page 2 of 714
***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: 11951017 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/15/2020
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947384
Page 3 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11951017]
2.Birth Date: UNK/UNK/1970
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947385
Page 4 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947386
Page 5 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947387
Page 6 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947388
Page 7 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arteriosclerosis of the legs]
Start Date: May/7/2009
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Spondylolisthesis]
Start Date: Aug/29/2017
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947389
Page 8 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947390
Page 9 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
2.Weight: [68.2]
3.Unit: kg
4.Height: [168.0]
5.Unit: cm
6.Body Mass Index: [24.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947391
Page 10 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947392
Page 11 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/15/2020
2.Randomization Number: [107913]
3.Randomization Group: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947393
Page 12 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNMDFP]
5.bSample ID [BNMDFR]
5.cSample ID [BN8WW0]
5.dSample ID [BN8WW1]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947394
Page 13 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8WVV]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947395
Page 14 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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/15/2020 16:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947396
Page 15 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947397
Page 16 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947398
Page 17 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947399
Page 18 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
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: RIGHT
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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947400
Page 19 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Nov/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947401
Page 20 of 714
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/3/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947402
Page 21 of 714
***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: 11951017 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/3/2020
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 [BN86DB]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947403
Page 22 of 714
***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: 11951017 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/3/2020 16:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947404
Page 23 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/1/2020
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947405
Page 24 of 714
***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: 11951017 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?YES
Ongoing?
NO
Stop Date:
Nov/10/2020
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Nov/10/2020
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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947406
Page 25 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
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: RIGHT
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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947407
Page 26 of 714
***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: 11951017 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/1/2020
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 [BN8KFS]
5.bSample ID [BN8KFT]
5.cSample ID [BNLWJK]
5.dSample ID [BNLWJL]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947408
Page 27 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947409
Page 28 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/12/2020
2.Date of First Symptom Started: Nov/12/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/18/2020
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? YES
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947410
Page 29 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [headache]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947411
Page 30 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947412
Page 31 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947413
Page 32 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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:[patient came into the office for a swab test. A self swab was not necessary.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947414
Page 33 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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/12/2020
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 [BN86K9]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947415
Page 34 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947416
Page 35 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done
Repeating Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947417
Page 36 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947418
Page 37 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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:
Nov/12/2020
3.Toxicity Grade: 2
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947419
Page 38 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947420
Page 39 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947421
Page 40 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest: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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947422
Page 41 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947423
Page 42 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947424
Page 43 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947425
Page 44 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947426
Page 45 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947427
Page 46 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947428
Page 47 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947429
Page 48 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947430
Page 49 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947431
Page 50 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947432
Page 51 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947433
Page 52 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947434
Page 53 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947435
Page 54 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947436
Page 55 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947437
Page 56 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947438
Page 57 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947439
Page 58 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947440
Page 59 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947441
Page 60 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947442
Page 61 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947443
Page 62 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947444
Page 63 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Mar/9/2021
2.Date of First Symptom Started: Mar/8/2021
3.Symptoms Ongoing? YES
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? YES
4 hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947445
Page 64 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Sniffles]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947446
Page 65 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947447
Page 66 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947448
Page 67 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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 [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947449
Page 68 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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:
Mar/9/2021
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 [BN8L7L]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947450
Page 69 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947451
Page 70 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done
Repeating Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947452
Page 71 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947453
Page 72 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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:
Mar/9/2021
3.Toxicity Grade: 2
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947454
Page 73 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947455
Page 74 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947456
Page 75 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest: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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947457
Page 76 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947458
Page 77 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947459
Page 78 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947460
Page 79 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947461
Page 80 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947462
Page 81 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947463
Page 82 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947464
Page 83 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947465
Page 84 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947466
Page 85 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947467
Page 86 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947468
Page 87 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947469
Page 88 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947470
Page 89 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947471
Page 90 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947472
Page 91 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947473
Page 92 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947474
Page 93 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947475
Page 94 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947476
Page 95 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947477
Page 96 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947478
Page 97 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/10/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947479
Page 98 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/10/2020Form: 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: 11951017 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/10/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8KRL]
5.bSample ID [BN8KRM]
5.cSample ID [BNLWVC]
5.dSample ID [BNLWVD]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947480
Page 99 of 714
***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: 11951017 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:
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947481
Page 100 of 714
***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: 11951017 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 [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947482
Page 101 of 714
***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: 11951017 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 worsening of Spondyl
olisthesis Dec/19/2020 UN
K:UNK NO
End Date Time:
Jan/16/2021 UNK:UN
K
Repeating
Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947483
Page 102 of 714
***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: 11951017 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)[worsening of Spondylolisthesis]
4.Start Date Time: Dec/19/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/16/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947484
Page 103 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 already existing Spondylolisthesis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021033541]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947485
Page 104 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947486
Page 105 of 714
***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: 11951017 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[ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947487
Page 106 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947488
Page 107 of 714
***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: 11951017 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: //
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947489
Page 108 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947490
Page 109 of 714
***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: 11951017 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?
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947491
Page 110 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947492
Page 111 of 714
***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: 11951017 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?
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947493
Page 112 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947494
Page 113 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947495
Page 114 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/18/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947496
Page 115 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/18/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947497
Page 116 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/18/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Dec/18/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947498
Page 117 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled Visit on
Jan/22/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947499
Page 118 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled Visit on
Jan/22/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Unplanned Assessments
1.Assessments Not Applicable Comments
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947500
Page 119 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled Visit on
Jan/22/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Contact Outcome
1.Contact Type: Not Applicable Comments
2.Was contact made? Not Applicable Comments
3.Comments: Not Applicable
[ ]Comments
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947501
Page 120 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled Visit on
Jan/22/2021Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Temperature: Not Applicable
[ ]Comments
Unit: Not Applicable Comments
Temperature Location: Not Applicable Comments
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947502
Page 121 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled Visit on
Jan/22/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 14-Jan-2021 02:20 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Not Applicable
//Comments
2.Injection Site Location Not Applicable Comments
3.Injection Site Body Side: Not Applicable Comments
Reaction
4.aReaction: REDNESS
Reaction Present: Not Applicable Comments
4.bReaction: SWELLING
Reaction Present: Not Applicable Comments
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: Not Applicable Comments
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: Not Applicable Comments
5.cSymptom: HEADACHE
Symptom Present: Not Applicable Comments
5.dSymptom: VOMITING
Symptom Present: Not Applicable Comments
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947503
Page 122 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled Visit on
Jan/22/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 14-Jan-2021 02:20 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.eSymptom: DIARRHEA
Symptom Present: Not Applicable Comments
5.fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: Not Applicable Comments
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: Not Applicable Comments
5 hSymptom: CHILLS
Symptom Present: Not Applicable Comments
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947504
Page 123 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947505
Page 124 of 714
***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: 11951017 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:
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947506
Page 125 of 714
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947507
Page 126 of 714
***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: 11951017 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?
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947508
Page 127 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947509
Page 128 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947510
Page 129 of 714
***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: 11951017 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/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947511
Page 130 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947512
Page 131 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947513
Page 132 of 714
***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: 11951017 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: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947514
Page 133 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947515
Page 134 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947516
Page 135 of 714
***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: 11951017 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: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947517
Page 136 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947518
Page 137 of 714
***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: 11951017 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
Feb/9/2021
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947519
Page 138 of 714
***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: 11951017 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 Done
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947520
Page 139 of 714
***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: 11951017 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
:Feb/9/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947521
Page 140 of 714
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947522
Page 141 of 714
***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: 11951017 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:
Feb/9/2021
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 [BN8L1M]
5.bSample ID [BN8L1N]
5.cSample ID [BNLWBK]
5.dSample ID [BNLWBL]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947523
Page 142 of 714
***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: 11951017 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/9/2021
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 [BN8L1P]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947524
Page 143 of 714
***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: 11951017 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/9/2021 12:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947525
Page 144 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947526
Page 145 of 714
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947527
Page 146 of 714
***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: 11951017 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:
Mar/2/2021
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 [BN8L70]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947528
Page 147 of 714
***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: 11951017 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: Mar/2/2021 14:21
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947529
Page 148 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947530
Page 149 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947531
Page 150 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947532
Page 151 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947533
Page 152 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947534
Page 153 of 714
***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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947535
Page 154 of 714
***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: 11951017 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: [ ]
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947536
Page 155 of 714
***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: 11951017 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/1/2020
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947537
Page 156 of 714
***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: 11951017 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
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947538
Page 157 of 714
***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: 11951017 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-11-2021 13:49:59 (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.
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0947539
Page 158 of 714
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-16-2020 13:40:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947540
Page 159 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947541
Page 160 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947542
Page 161 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947543
Page 162 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947544
Page 163 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947545
Page 164 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947546
Page 165 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Nov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947547
Page 166 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Nov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947548
Page 167 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Nov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947549
Page 168 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Nov-12-2020 12:38:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947550
Page 169 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:39:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947551
Page 170 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:39:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947552
Page 171 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-12-2020 12:39:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947553
Page 172 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-12-2020 12:39:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947554
Page 173 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-12-2020 12:39:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947555
Page 174 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-12-2020 12:39:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947556
Page 175 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Nov-12-2020 12:39:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947557
Page 176 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:42:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947558
Page 177 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:42:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947559
Page 178 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-12-2020 12:42:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947560
Page 179 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-12-2020 12:42:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947561
Page 180 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-12-2020 12:42:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947562
Page 181 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947563
Page 182 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947564
Page 183 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947565
Page 184 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947566
Page 185 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947567
Page 186 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947568
Page 187 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947569
Page 188 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947570
Page 189 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947571
Page 190 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947572
Page 191 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947573
Page 192 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947574
Page 193 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947575
Page 194 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947576
Page 195 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947577
Page 196 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947578
Page 197 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947579
Page 198 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947580
Page 199 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947581
Page 200 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947582
Page 201 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947583
Page 202 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947584
Page 203 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947585
Page 204 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947586
Page 205 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947587
Page 206 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947588
Page 207 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947589
Page 208 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947590
Page 209 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947591
Page 210 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947592
Page 211 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947593
Page 212 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947594
Page 213 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-12-2020 12:43:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947595
Page 214 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947596
Page 215 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947597
Page 216 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947598
Page 217 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947599
Page 218 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947600
Page 219 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947601
Page 220 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947602
Page 221 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947603
Page 222 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947604
Page 223 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947605
Page 224 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947606
Page 225 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947607
Page 226 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947608
Page 227 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947609
Page 228 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947610
Page 229 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947611
Page 230 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947612
Page 231 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947613
Page 232 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947614
Page 233 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947615
Page 234 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947616
Page 235 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947617
Page 236 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947618
Page 237 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947619
Page 238 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947620
Page 239 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947621
Page 240 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947622
Page 241 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947623
Page 242 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947624
Page 243 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947625
Page 244 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947626
Page 245 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947627
Page 246 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947628
Page 247 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947629
Page 248 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947630
Page 249 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947631
Page 250 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947632
Page 251 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947633
Page 252 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947634
Page 253 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947635
Page 254 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947636
Page 255 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947637
Page 256 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947638
Page 257 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947639
Page 258 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jNov-12-2020 12:43:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947640
Page 259 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:45:13 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947641
Page 260 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:45:13 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947642
Page 261 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-12-2020 12:45:13 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947643
Page 262 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-12-2020 12:45:13 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947644
Page 263 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-12-2020 12:45:13 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947645
Page 264 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-12-2020 12:45:13 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947646
Page 265 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:45:55 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947647
Page 266 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:45:55 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947648
Page 267 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-12-2020 12:45:55 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947649
Page 268 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:46:09 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947650
Page 269 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:46:09 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947651
Page 270 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-12-2020 12:46:09 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947652
Page 271 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-12-2020 12:46:09 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947653
Page 272 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:46:22 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947654
Page 273 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:46:22 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947655
Page 274 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-12-2020 12:46:22 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947656
Page 275 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-12-2020 12:46:22 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947657
Page 276 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-12-2020 12:46:22 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947658
Page 277 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-12-2020 12:46:22 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947659
Page 278 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Nov-12-2020 12:46:22 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947660
Page 279 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 12:46:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947661
Page 280 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-12-2020 12:46:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947662
Page 281 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-12-2020 12:46:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947663
Page 282 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-12-2020 12:46:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947664
Page 283 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/12/2020Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-12-2020 12:46:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947665
Page 284 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormMar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947666
Page 285 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Mar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947667
Page 286 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Mar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947668
Page 287 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Mar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947669
Page 288 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Mar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947670
Page 289 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Mar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947671
Page 290 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Mar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947672
Page 291 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Mar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947673
Page 292 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Mar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947674
Page 293 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: 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: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Mar-09-2021 12:32:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947675
Page 294 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormMar-09-2021 12:35:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947676
Page 295 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Mar-09-2021 12:35:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947677
Page 296 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Mar-09-2021 12:35:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947678
Page 297 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Mar-09-2021 12:35:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae2f9a\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0947679
Page 298 of 714
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unsched
…[truncated]