Document text
Page 1 of 416
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820479
Page 2 of 416
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820480
Page 3 of 416
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11941058]
2.Birth Date: UNK/UNK/1970
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820481
Page 4 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820482
Page 5 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820483
Page 6 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820484
Page 7 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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:[Arterial Hypertension]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Uterus myoma]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
Aug/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Alopecia arreata]
Start Date: Mar/UNK/2017
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hashimoto Thyreoiditis]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[av reentry tachykardie]
Start Date: Jun/UNK/2011
Ongoing: NO
End Date:
Jul/UNK/2011
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820485
Page 8 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Postmenopausal]
Start Date: Mar/UNK/2018
Ongoing: YES
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820486
Page 9 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820487
Page 10 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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: [69.2]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [23.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: EAR
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820488
Page 11 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820489
Page 12 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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: [109925]
3.Randomization Group: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820490
Page 13 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 [BN8J51]
5.bSample ID [BN8J52]
5.cSample ID [BNMD5L]
5.dSample ID [BNMD5M]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820491
Page 14 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 [BN8J4Y]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820492
Page 15 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 15:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820493
Page 16 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820494
Page 17 of 416
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820495
Page 18 of 416
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Oct/25/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Oct/25/2020
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820496
Page 19 of 416
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820497
Page 20 of 416
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Nov/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: EAR
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820498
Page 21 of 416
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/10/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820499
Page 22 of 416
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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/10/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8HN8]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820500
Page 23 of 416
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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/10/2020 13:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820501
Page 24 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820502
Page 25 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820503
Page 26 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820504
Page 27 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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/8/2020
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 [BN8HVJ]
5.bSample ID [BN8HVK]
5.cSample ID [BNMDD0]
5.dSample ID [BNMDD1]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820505
Page 28 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820506
Page 29 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/8/2021
2.Date of First Symptom Started: Feb/3/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/11/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820507
Page 30 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.aSymptoms - Other Text: [ ]
5.bSymptoms - Other Text: [ ]
5.cSymptoms - Other Text: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820508
Page 31 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820509
Page 32 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
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
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820510
Page 33 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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:[performed on site]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820511
Page 34 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
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 [BN15JM]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820512
Page 35 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820513
Page 36 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820514
Page 37 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820515
Page 38 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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?NO
3.Toxicity Grade: 2
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820516
Page 39 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820517
Page 40 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820518
Page 41 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined Id
entifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820519
Page 42 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820520
Page 43 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820521
Page 44 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820522
Page 45 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820523
Page 46 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applicable Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820524
Page 47 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820525
Page 48 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820526
Page 49 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820527
Page 50 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820528
Page 51 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820529
Page 52 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820530
Page 53 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Feb/8/2021 Record Identifier: Systolic: Diastolic:
1 147 103 Repeating Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820531
Page 54 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/8/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [147]
Diastolic: [103]
Respiratory Rate in
respirations/minute:[14]
Heart Rate in beats/minute: [75]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820532
Page 55 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Feb/8/2021 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820533
Page 56 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/8/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820534
Page 57 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820535
Page 58 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820536
Page 59 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820537
Page 60 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable 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 Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820538
Page 61 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820539
Page 62 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820540
Page 63 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Mar/08/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820541
Page 64 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Mar/08/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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:
Mar/8/2021
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 [BN15LM]
5.bSample ID [BN15LN]
5.cSample ID [BNMPNK]
5.dSample ID [BNMPNL]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820542
Page 65 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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:
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820543
Page 66 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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 [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820544
Page 67 of 416
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EV
ENT 1 Pain at injection site Jan/12/2021 20:00
NO
End Date Time:
Feb/15/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Pain at injection site Feb/4/2021 UNK:
UNK NO
End Date Time:
Feb/11/2021 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 Headache Feb/3/2021 20:00 NO
End Date Time:
Feb/11/2021 UNK:UNK
Repeating
Pages
4.ADVERSE EV
ENT 4 Swelling lymph node (axill
ar right) Feb/4/2021 UNK:
UNK NO
End Date Time:
Feb/11/2021 UNK:UNK
Repeating
Pages
5.ADVERSE EV
ENT 5 Pain at thumb base joint Feb/4/2021 UNK:
UNK NO
End Date Time:
Feb/11/2021 UNK:UNK
Repeating
Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820545
Page 68 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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)[Pain at injection site]
4.Start Date Time: Jan/12/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/15/2021 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820546
Page 69 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820547
Page 70 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pain at injection site]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820548
Page 71 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820549
Page 72 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache]
4.Start Date Time: Feb/3/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820550
Page 73 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820551
Page 74 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Swelling lymph node (axillar right)]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820552
Page 75 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820553
Page 76 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pain at thumb base joint]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820554
Page 77 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820555
Page 78 of 416
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ongo
ingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820556
Page 79 of 416
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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[ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820557
Page 80 of 416
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart Date Form Instance
1.1 VACCINATIONS NO Influvac tetra Nov/25/20
20 Repeating
Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820558
Page 81 of 416
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Influvac tetra]
5.Date: Nov/25/2020
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820559
Page 82 of 416
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820560
Page 83 of 416
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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?
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820561
Page 84 of 416
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820562
Page 85 of 416
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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?
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820563
Page 86 of 416
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820564
Page 87 of 416
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820565
Page 88 of 416
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/03/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820566
Page 89 of 416
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/03/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820567
Page 90 of 416
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/03/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/3/2021
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Vaccination reaction:
Headache (moderate), Fever (37.7 degrees), Chills (moderate), pain at injection site
(moderate)]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820568
Page 91 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820569
Page 92 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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:
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820570
Page 93 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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:
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820571
Page 94 of 416
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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?
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820572
Page 95 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820573
Page 96 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820574
Page 97 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820575
Page 98 of 416
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820576
Page 99 of 416
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820577
Page 100 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820578
Page 101 of 416
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820579
Page 102 of 416
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/12/2021
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820580
Page 103 of 416
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820581
Page 104 of 416
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/12/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820582
Page 105 of 416
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/12/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820583
Page 106 of 416
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN15CY]
5.bSample ID [BN15CZ]
5.cSample ID [BNMPKK]
5.dSample ID [BNMPKL]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820584
Page 107 of 416
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN15CT]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820585
Page 108 of 416
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/12/2021 14:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820586
Page 109 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820587
Page 110 of 416
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820588
Page 111 of 416
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820589
Page 112 of 416
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820590
Page 113 of 416
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/2/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820591
Page 114 of 416
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN15J3]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820592
Page 115 of 416
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/2/2021 14:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820593
Page 116 of 416
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820594
Page 117 of 416
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/2/2021
3.Comments: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820595
Page 118 of 416
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820596
Page 119 of 416
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820597
Page 120 of 416
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820598
Page 121 of 416
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820599
Page 122 of 416
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Mar/2/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820600
Page 123 of 416
***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: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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/8/2020
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820601
Page 124 of 416
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 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
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820602
Page 125 of 416
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Andreas Eich Approved Mar-10-2021 11:22:59 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820603
Page 126 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-19-2020 17:28:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820604
Page 127 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820605
Page 128 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820606
Page 129 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820607
Page 130 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820608
Page 131 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820609
Page 132 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820610
Page 133 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820611
Page 134 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Feb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820612
Page 135 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Feb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820613
Page 136 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Feb-10-2021 11:57:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820614
Page 137 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 11:15:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820615
Page 138 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 11:15:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820616
Page 139 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 11:15:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820617
Page 140 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 11:15:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820618
Page 141 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-08-2021 11:15:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820619
Page 142 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-08-2021 11:15:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820620
Page 143 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-08-2021 11:15:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820621
Page 144 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 11:16:15 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820622
Page 145 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 11:16:15 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820623
Page 146 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 11:16:15 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820624
Page 147 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 11:16:15 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820625
Page 148 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-08-2021 11:16:15 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820626
Page 149 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820627
Page 150 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820628
Page 151 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820629
Page 152 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820630
Page 153 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820631
Page 154 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820632
Page 155 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820633
Page 156 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820634
Page 157 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820635
Page 158 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820636
Page 159 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820637
Page 160 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820638
Page 161 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820639
Page 162 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820640
Page 163 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820641
Page 164 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820642
Page 165 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820643
Page 166 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820644
Page 167 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820645
Page 168 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820646
Page 169 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820647
Page 170 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820648
Page 171 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820649
Page 172 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820650
Page 173 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820651
Page 174 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820652
Page 175 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820653
Page 176 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820654
Page 177 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820655
Page 178 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820656
Page 179 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820657
Page 180 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820658
Page 181 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-08-2021 11:16:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820659
Page 182 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820660
Page 183 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820661
Page 184 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820662
Page 185 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820663
Page 186 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820664
Page 187 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820665
Page 188 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820666
Page 189 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820667
Page 190 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820668
Page 191 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820669
Page 192 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820670
Page 193 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820671
Page 194 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820672
Page 195 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820673
Page 196 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820674
Page 197 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820675
Page 198 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820676
Page 199 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820677
Page 200 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820678
Page 201 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820679
Page 202 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820680
Page 203 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820681
Page 204 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820682
Page 205 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820683
Page 206 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820684
Page 207 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820685
Page 208 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820686
Page 209 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820687
Page 210 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820688
Page 211 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820689
Page 212 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820690
Page 213 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820691
Page 214 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820692
Page 215 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820693
Page 216 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820694
Page 217 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820695
Page 218 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820696
Page 219 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820697
Page 220 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820698
Page 221 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820699
Page 222 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820700
Page 223 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820701
Page 224 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820702
Page 225 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820703
Page 226 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jFeb-08-2021 11:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820704
Page 227 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 11:25:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820705
Page 228 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 11:25:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820706
Page 229 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 11:25:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820707
Page 230 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 11:25:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820708
Page 231 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 11:25:31 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820709
Page 232 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 11:25:31 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820710
Page 233 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 11:25:31 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820711
Page 234 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 11:25:31 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820712
Page 235 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-08-2021 11:25:31 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820713
Page 236 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-08-2021 11:25:31 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820714
Page 237 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-08-2021 11:25:31 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820715
Page 238 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 11:26:00 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820716
Page 239 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 11:26:00 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820717
Page 240 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 11:26:00 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820718
Page 241 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 11:26:00 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820719
Page 242 of 416
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-08-2021 11:26:00 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820720
Page 243 of 416
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormJan-12-2021 14:52:14 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820721
Page 244 of 416
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Andreas Eich Approved Mar-10-2021 11:22:59 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-08-2021 13:41:16 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich Approved Mar-08-2021 08:56:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-02-2021 10:25:39 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich Approved Mar-02-2021 09:16:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820722
Page 245 of 416
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-26-2021 13:41:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich Approved Feb-17-2021 08:51:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-16-2021 12:39:41 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich Approved Feb-15-2021 08:49:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820723
Page 246 of 416
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
N/A Feb-08-2021 11:05:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-06-2021 11:49:57 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-02-2021 13:56:54 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich Approved Jan-20-2021 13:18:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-18-2021 11:03:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich Approved Jan-12-2021 17:55:58 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820724
Page 247 of 416
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-11-2021 16:33:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Dec-16-2020 11:31:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-08-2020 16:06:07 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich Approved Nov-16-2020 08:03:57 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820725
Page 248 of 416
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
N/A Nov-12-2020 08:38:35 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich Approved Nov-11-2020 09:58:59 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-10-2020 12:35:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich Approved Oct-29-2020 17:03:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AndreasEich, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820726
Page 249 of 416
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-19-2020 17:27:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-19-2020 17:27:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820727
Page 250 of 416
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-19-2020 17:27:28
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/19/2020Initial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820728
Page 251 of 416
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-19-2020 17:27:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11941058Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-19-2020 17:22:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
UNK/UNK/1970Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-19-2020 17:27:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-19-2020 17:27:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-19-2020 17:27:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820729
Page 252 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 17:27:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820730
Page 253 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-19-2020 17:28:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 17:28:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 17:28:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820731
Page 254 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Oct-20-2020 10:56:54
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Arterial Hyperten
sion
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-20-2020 10:56:54
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-20-2020 10:56:54
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Arterial HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-20-2020 10:56:54
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-20-2020 10:56:54
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-20-2020 10:58:21
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820732
Page 255 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb Line/MH Number: 2
Medical History Te
rm:Uterus myoma
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
Aug/UNK/20
19
1.b Line/MH Number:
Date Location User Value Reason
Oct-20-2020 10:58:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-20-2020 10:58:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Uterus myomaInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-20-2020 10:58:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-20-2020 10:58:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/UNK/2019Initial Entry
1.c
Date Location User Value Reason
Oct-20-2020 10:58:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820733
Page 256 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Medical History Ter
m:Alopecia arreat
a
Start Date: Mar/UNK/201
7
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Oct-20-2020 10:58:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-20-2020 10:58:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Alopecia arreataInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-20-2020 10:58:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Mar/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-20-2020 10:58:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-20-2020 13:53:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Hashimoto Thyre
oiditis
Start Date: UNK/UNK/2015
Ongoing: YESTranscription Error
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820734
Page 257 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-20-2020 10:59:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Hashimoto Thyre
oditis
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0820735
Page 258 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.d Line/MH Number:
Date Location User Value Reason
Oct-20-2020 10:59:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-20-2020
14:55:00
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Oct-20-2020
13:53:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dTranscription Error
Oct-20-2020
13:53:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Hashimoto Thyreo
iditisTranscription Error
Oct-20-2020
12:40:05
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Opened Clarify
HASHIMOTO
THYREODITIS as
follows...Should
spelling be
HASHIMOTO
THYREOIDITIS?
If so, edit as such or
clarify. Thank you.
Oct-20-2020
10:59:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Hashimoto Thyreo
ditisInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-20-2020 10:59:33
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0820736
Page 259 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
1.d Ongoing:
Date Location User Value Reason
Oct-22-2020 16:19:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-21-2020 16:49:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered The patient is not under
systemic treatment with
immunosuppressive
drugs.
Oct-21-2020 16:01:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened is the patient under
systemic treatment with
immunosuppressive
drugs (including
steroids) for the
ongoing Hashimoto's
thyroiditis?
Oct-20-2020 10:59:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-20-2020 11:00:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:av reentry tachyka
rdie
Start Date: Jun/UNK/2011
Ongoing: NO
End Date:
Jul/UNK/2011Initial Entry
090177e196ae3f19\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0820737
Page 260 of 416
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer klinische
Forschung
Subject No: 11941058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.e Line/MH Number:
Date Location User Value Reason
Oct-20-2020 11:00:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-20-2020 11:00:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
av reentry tachykardieInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-20-2020 11:00:44
(UTC+01:00) Sarajevo,
S
…[truncated]