Document text
Page 1 of 652
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949192
Page 2 of 652
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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/19/2020
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949193
Page 3 of 652
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11951132]
2.Birth Date: UNK/UNK/1948
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:
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949194
Page 4 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949195
Page 5 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949196
Page 6 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949197
Page 7 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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:[copd]
Start Date: UNK/UNK/2008
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2003
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[struma diffusa]
Start Date: UNK/UNK/1997
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postmenopausal]
Start Date: UNK/UNK/2001
Ongoing: YES
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949198
Page 8 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949199
Page 9 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
2.Weight: [56.3]
3.Unit: kg
4.Height: [162.0]
5.Unit: cm
6.Body Mass Index: [21.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949200
Page 10 of 652
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949201
Page 11 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/19/2020
2.Randomization Number: [270713]
3.Randomization Group: [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949202
Page 12 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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/19/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNMDPV]
5.bSample ID [BNMDPW]
5.cSample ID [BN868X]
5.dSample ID [BN868Y]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949203
Page 13 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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/19/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8694]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949204
Page 14 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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/19/2020 13:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949205
Page 15 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949206
Page 16 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/7/2020
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949207
Page 17 of 652
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949208
Page 18 of 652
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949209
Page 19 of 652
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949210
Page 20 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Nov/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949211
Page 21 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949212
Page 22 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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/7/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN86GT]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949213
Page 23 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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/7/2020 11:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949214
Page 24 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/5/2020
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949215
Page 25 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949216
Page 26 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949217
Page 27 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949218
Page 28 of 652
***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: 11951132 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/5/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8KM0]
5.bSample ID [BN8KM1]
5.cSample ID [BNLWPS]
5.dSample ID [BNLWPT]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949219
Page 29 of 652
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949220
Page 30 of 652
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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 [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949221
Page 31 of 652
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949222
Page 32 of 652
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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 [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949223
Page 33 of 652
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949224
Page 34 of 652
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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 [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949225
Page 35 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949226
Page 36 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/2/2020
2.Date of First Symptom Started: Nov/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/5/2020
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? YES Comments
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949227
Page 37 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949228
Page 38 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Colle
ctionSpecimen T
ypeSpecimen Collection L
ocationAssay Code and Desc
riptionDevice T
ypeForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Done
Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949229
Page 39 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949230
Page 40 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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 today for a nasal swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949231
Page 41 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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/2/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN86CY]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949232
Page 42 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949233
Page 43 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949234
Page 44 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntTreatme
ntStart Da
teForm Instance
1.Not Done Not Done Not Don
e Not Don
e Not Don
e Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949235
Page 45 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949236
Page 46 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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:
[COPD Exacerbation]
Date of Diagnosis:
Nov/2/2020
3.Toxicity Grade: 1
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949237
Page 47 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtain
edToxicity Gra
deForm Instance
1.Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949238
Page 48 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949239
Page 49 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab TestVendor
NameCollection
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 Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949240
Page 50 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949241
Page 51 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949242
Page 52 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949243
Page 53 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949244
Page 54 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Done Not Done Not Done Not Done
Sponsor-Define
d IdentifierTest:Resul
t:
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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949245
Page 55 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949246
Page 56 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949247
Page 57 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949248
Page 58 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949249
Page 59 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949250
Page 60 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949251
Page 61 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949252
Page 62 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949253
Page 63 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949254
Page 64 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949255
Page 65 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessme
ntArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949256
Page 66 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949257
Page 67 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949258
Page 68 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949259
Page 69 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949260
Page 70 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949261
Page 71 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949262
Page 72 of 652
***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: 11951132 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/7/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949263
Page 73 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949264
Page 74 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Colle
ctionSpecimen T
ypeSpecimen Collection L
ocationAssay Code and Desc
riptionDevice T
ypeForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Done
Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949265
Page 75 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949266
Page 76 of 652
***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: 11951132 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 [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949267
Page 77 of 652
***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: 11951132 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 [BN8L7J]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949268
Page 78 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949269
Page 79 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949270
Page 80 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntTreatme
ntStart Da
teForm Instance
1.Not Done Not Done Not Don
e Not Don
e Not Don
e Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949271
Page 81 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949272
Page 82 of 652
***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: 11951132 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:
[Dyspnoea]
Date of Diagnosis:
Mar/9/2021
3.Toxicity Grade: 2
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949273
Page 83 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtain
edToxicity Gra
deForm Instance
1.Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949274
Page 84 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949275
Page 85 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab TestVendor
NameCollection
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 Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949276
Page 86 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949277
Page 87 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949278
Page 88 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949279
Page 89 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949280
Page 90 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Done Not Done Not Done Not Done
Sponsor-Define
d IdentifierTest:Resul
t:
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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949281
Page 91 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949282
Page 92 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949283
Page 93 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949284
Page 94 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949285
Page 95 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949286
Page 96 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949287
Page 97 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949288
Page 98 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949289
Page 99 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949290
Page 100 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949291
Page 101 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessme
ntArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949292
Page 102 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949293
Page 103 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949294
Page 104 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949295
Page 105 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949296
Page 106 of 652
***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: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949297
Page 107 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/30/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949298
Page 108 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/30/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/30/2020
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 [BN8KF9]
5.bSample ID [BN8KFB]
5.cSample ID [BNLWJ3]
5.dSample ID [BNLWJ4]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949299
Page 109 of 652
***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: 11951132 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:
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949300
Page 110 of 652
***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: 11951132 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 [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949301
Page 111 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Identi
fierAdverse E
ventStart DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Lymphoma
Dec/30/2020 UNK
:UNK NO
End Date Time:
Mar/2/2021 UNK:UNK
Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949302
Page 112 of 652
***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: 11951132 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)[Lymphoma]
4.Start Date Time: Dec/30/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/2/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949303
Page 113 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021193949]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949304
Page 114 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryMedication E
rrorStart D
ateIs the medication error Stil
l OngoingStudy Medication Error
s ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949305
Page 115 of 652
***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: 11951132 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[ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949306
Page 116 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949307
Page 117 of 652
***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: 11951132 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: //
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949308
Page 118 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949309
Page 119 of 652
***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: 11951132 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?
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949310
Page 120 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949311
Page 121 of 652
***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: 11951132 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?
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949312
Page 122 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949313
Page 123 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949314
Page 124 of 652
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949315
Page 125 of 652
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949316
Page 126 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949317
Page 127 of 652
***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: 11951132 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:
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949318
Page 128 of 652
***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: 11951132 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:
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949319
Page 129 of 652
***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: 11951132 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?
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949320
Page 130 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949321
Page 131 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949322
Page 132 of 652
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949323
Page 133 of 652
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949324
Page 134 of 652
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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 [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949325
Page 135 of 652
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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 [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949326
Page 136 of 652
***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: 11951132 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/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949327
Page 137 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949328
Page 138 of 652
***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: 11951132 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949329
Page 139 of 652
***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: 11951132 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: [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949330
Page 140 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949331
Page 141 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949332
Page 142 of 652
***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: 11951132 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: [ ]
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949333
Page 143 of 652
***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: 11951132 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/5/2020
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949334
Page 144 of 652
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949335
Page 145 of 652
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949336
Page 146 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-19-2020 13:23:58 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949337
Page 147 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-07-2020 14:41:36 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949338
Page 148 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-07-2020 14:41:36 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949339
Page 149 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-07-2020 14:41:36 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949340
Page 150 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-07-2020 14:41:36 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949341
Page 151 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-07-2020 14:41:36 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949342
Page 152 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-07-2020 14:41:36 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949343
Page 153 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:41:36 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949344
Page 154 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:41:36 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949345
Page 155 of 652
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:41:36 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949346
Page 156 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-07-2020 14:04:50 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949347
Page 157 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-07-2020 14:04:50 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949348
Page 158 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-07-2020 14:04:50 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949349
Page 159 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-07-2020 14:04:50 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949350
Page 160 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-07-2020 14:04:50 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949351
Page 161 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-07-2020 14:04:50 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949352
Page 162 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:04:50 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949353
Page 163 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:04:50 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949354
Page 164 of 652
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:04:50 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949355
Page 165 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4.cNov-06-2020 12:46:33 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebDose increase of Foster
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949356
Page 166 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949357
Page 167 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949358
Page 168 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949359
Page 169 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949360
Page 170 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949361
Page 171 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949362
Page 172 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Nov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949363
Page 173 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Nov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949364
Page 174 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Nov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949365
Page 175 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Nov-02-2020 11:12:53 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949366
Page 176 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:26:00 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949367
Page 177 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:26:00 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949368
Page 178 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-02-2020 11:26:00 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949369
Page 179 of 652
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-02-2020 11:26:00 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949370
Page 180 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-02-2020 11:26:00 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949371
Page 181 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-02-2020 11:26:00 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949372
Page 182 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Nov-02-2020 11:26:00 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949373
Page 183 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:16:05 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949374
Page 184 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:16:05 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949375
Page 185 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-02-2020 11:16:05 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949376
Page 186 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-02-2020 11:16:05 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949377
Page 187 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-02-2020 11:16:05 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949378
Page 188 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949379
Page 189 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949380
Page 190 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949381
Page 191 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949382
Page 192 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949383
Page 193 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949384
Page 194 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949385
Page 195 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949386
Page 196 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949387
Page 197 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949388
Page 198 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949389
Page 199 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949390
Page 200 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949391
Page 201 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949392
Page 202 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949393
Page 203 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949394
Page 204 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949395
Page 205 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949396
Page 206 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949397
Page 207 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949398
Page 208 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949399
Page 209 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949400
Page 210 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949401
Page 211 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949402
Page 212 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949403
Page 213 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949404
Page 214 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949405
Page 215 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949406
Page 216 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949407
Page 217 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949408
Page 218 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949409
Page 219 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949410
Page 220 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-02-2020 11:16:25 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949411
Page 221 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949412
Page 222 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949413
Page 223 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949414
Page 224 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949415
Page 225 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949416
Page 226 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949417
Page 227 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949418
Page 228 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949419
Page 229 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949420
Page 230 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949421
Page 231 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949422
Page 232 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949423
Page 233 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949424
Page 234 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949425
Page 235 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949426
Page 236 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949427
Page 237 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949428
Page 238 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949429
Page 239 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949430
Page 240 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949431
Page 241 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949432
Page 242 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949433
Page 243 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949434
Page 244 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949435
Page 245 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949436
Page 246 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949437
Page 247 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949438
Page 248 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949439
Page 249 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949440
Page 250 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949441
Page 251 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949442
Page 252 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949443
Page 253 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949444
Page 254 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.hNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949445
Page 255 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.hNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949446
Page 256 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.hNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949447
Page 257 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.hNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949448
Page 258 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949449
Page 259 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949450
Page 260 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949451
Page 261 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949452
Page 262 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949453
Page 263 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949454
Page 264 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949455
Page 265 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jNov-02-2020 11:16:48 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949456
Page 266 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:17:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949457
Page 267 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:17:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949458
Page 268 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-02-2020 11:17:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949459
Page 269 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-02-2020 11:17:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949460
Page 270 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-02-2020 11:17:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949461
Page 271 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-02-2020 11:17:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949462
Page 272 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:17:42 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949463
Page 273 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:17:42 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949464
Page 274 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aNov-02-2020 11:17:42 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949465
Page 275 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:17:58 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949466
Page 276 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:17:58 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949467
Page 277 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-02-2020 11:17:58 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949468
Page 278 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-02-2020 11:17:58 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949469
Page 279 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:18:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949470
Page 280 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:18:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949471
Page 281 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-02-2020 11:18:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949472
Page 282 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-02-2020 11:18:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949473
Page 283 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-02-2020 11:18:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949474
Page 284 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-02-2020 11:18:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949475
Page 285 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Nov-02-2020 11:18:14 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949476
Page 286 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-02-2020 11:18:37 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949477
Page 287 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-02-2020 11:18:37 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949478
Page 288 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-02-2020 11:18:37 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949479
Page 289 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-02-2020 11:18:37 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949480
Page 290 of 652
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/02/2020Form: 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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-02-2020 11:18:37 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949481
Page 291 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormMar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949482
Page 292 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Mar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949483
Page 293 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Mar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949484
Page 294 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Mar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949485
Page 295 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Mar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949486
Page 296 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Mar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949487
Page 297 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Mar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949488
Page 298 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Mar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949489
Page 299 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Mar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949490
Page 300 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Mar-09-2021 14:06:20 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949491
Page 301 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormMar-09-2021 14:15:19 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949492
Page 302 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Mar-09-2021 14:15:19 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949493
Page 303 of 652
***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: 11951132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Mar-09-2021 14:15:19 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Done
090177e196ae2f95\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949494
Page 304 of 652
***Confidential***
Header
…[truncated]