125742 S1 M5 CRF c4591001 1194 11941002

Document text

Page 1 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819424
Page 2 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/15/2020
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819425
Page 3 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11941002]
2.Birth Date: UNK/UNK/1963
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819426
Page 4 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819427
Page 5 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819428
Page 6 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819429
Page 7 of 405
***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: 11941002 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/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819430
Page 8 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819431
Page 9 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
2.Weight: [96.1]
3.Unit: kg
4.Height: [190.0]
5.Unit: cm
6.Body Mass Index: [26.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: EAR
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819432
Page 10 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/15/2020
2.Randomization Number: [269471]
3.Randomization Group: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819433
Page 11 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8HZH]
5.bSample ID [BN8HZJ]
5.cSample ID [BNMD1W]
5.dSample ID [BNMD1X]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819434
Page 12 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8HZB]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819435
Page 13 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/15/2020 13:40
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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819436
Page 14 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819437
Page 15 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819438
Page 16 of 405
***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: 11941002 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?YES
Ongoing?
NO
Stop Date:
Oct/21/2020
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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819439
Page 17 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819440
Page 18 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: EAR
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819441
Page 19 of 405
***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: 11941002 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/5/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8HLT]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819442
Page 20 of 405
***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: 11941002 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/5/2020 14:51
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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819443
Page 21 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819444
Page 22 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819445
Page 23 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819446
Page 24 of 405
***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: 11941002 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/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8HSC]
5.bSample ID [BN8HSD]
5.cSample ID [BNMD9W]
5.dSample ID [BNMD9X]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819447
Page 25 of 405
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819448
Page 26 of 405
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/4/2021
2.Date of First Symptom Started: Feb/2/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/13/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819449
Page 27 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819450
Page 28 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819451
Page 29 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819452
Page 30 of 405
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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:[collected on site]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819453
Page 31 of 405
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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/4/2021
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 [BN15JH]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819454
Page 32 of 405
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819455
Page 33 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819456
Page 34 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819457
Page 35 of 405
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819458
Page 36 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819459
Page 37 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819460
Page 38 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable 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 Repeating
Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819461
Page 39 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819462
Page 40 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819463
Page 41 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819464
Page 42 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819465
Page 43 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819466
Page 44 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819467
Page 45 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819468
Page 46 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819469
Page 47 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819470
Page 48 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819471
Page 49 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819472
Page 50 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
 1.Feb/4/2021 Record Identifier: Systolic: Diastolic:
1  128  67 Repeating Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819473
Page 51 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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/4/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [128]
Diastolic: [67]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [83]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819474
Page 52 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
1  Not Applicable Repeating Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819475
Page 53 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819476
Page 54 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819477
Page 55 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819478
Page 56 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819479
Page 57 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819480
Page 58 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819481
Page 59 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819482
Page 60 of 405
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/11/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819483
Page 61 of 405
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/11/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 11941002 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/11/2021
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 [BN15LW]
5.bSample ID [BN15LX]
5.cSample ID [BNMPNS]
5.dSample ID [BNMPNT]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819484
Page 62 of 405
***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: 11941002 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:
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819485
Page 63 of 405
***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: 11941002 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 [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819486
Page 64 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Pain at injection site  Jan/11/2021 20:0
0 NO
End Date Time:
Jan/13/2021 08:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  enlarged lymph nodes (ri
ght axillar) Feb/2/2021 UN
K:UNK NO
End Date Time:
Feb/13/2021 08:00
 Repeating
Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819487
Page 65 of 405
***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: 11941002 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/11/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/13/2021 08:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819488
Page 66 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819489
Page 67 of 405
***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: 11941002 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)[enlarged lymph nodes (right axillar)]
4.Start Date Time: Feb/2/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/13/2021 08:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819490
Page 68 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819491
Page 69 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819492
Page 70 of 405
***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: 11941002 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[ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819493
Page 71 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart Da
teForm Instanc
e
 1.1  VACCINATIONS  NO  Vaxigrip  Sep/25/2
020 Repeating
Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819494
Page 72 of 405
***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: 11941002 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).[Vaxigrip]
5.Date: Sep/25/2020
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819495
Page 73 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819496
Page 74 of 405
***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: 11941002 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?
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819497
Page 75 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819498
Page 76 of 405
***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: 11941002 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?
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819499
Page 77 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819500
Page 78 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819501
Page 79 of 405
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819502
Page 80 of 405
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819503
Page 81 of 405
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11941002 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/2/2021
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Patient reported moderate Fatigue/tiredness since this morning. Vacc reaction.]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819504
Page 82 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819505
Page 83 of 405
***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: 11941002 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:
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819506
Page 84 of 405
***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: 11941002 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?
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819507
Page 85 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819508
Page 86 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819509
Page 87 of 405
***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: 11941002 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/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819510
Page 88 of 405
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819511
Page 89 of 405
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819512
Page 90 of 405
***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: 11941002 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: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819513
Page 91 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819514
Page 92 of 405
***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: 11941002 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/11/2021
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819515
Page 93 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819516
Page 94 of 405
***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: 11941002 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/11/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819517
Page 95 of 405
***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: 11941002 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/11/2021
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 [BN15CB]
5.bSample ID [BN15CC]
5.cSample ID [BNMPK5]
5.dSample ID [BNMPK6]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819518
Page 96 of 405
***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: 11941002 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/11/2021
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 [BN15C4]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819519
Page 97 of 405
***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: 11941002 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/11/2021 14:09
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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819520
Page 98 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819521
Page 99 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819522
Page 100 of 405
***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: 11941002 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: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819523
Page 101 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819524
Page 102 of 405
***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: 11941002 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/1/2021
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 [BN15HZ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819525
Page 103 of 405
***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: 11941002 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/1/2021 14:20
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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819526
Page 104 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819527
Page 105 of 405
***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: 11941002 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/1/2021
3.Comments: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819528
Page 106 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819529
Page 107 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819530
Page 108 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819531
Page 109 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819532
Page 110 of 405
***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: 11941002 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/1/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819533
Page 111 of 405
***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: 11941002 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/3/2020
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819534
Page 112 of 405
***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: 11941002 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
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819535
Page 113 of 405
***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: 11941002 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-12-2021 13:47:27 (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.
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819536
Page 114 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-19-2020 11:21:09 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819537
Page 115 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819538
Page 116 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819539
Page 117 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819540
Page 118 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819541
Page 119 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819542
Page 120 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819543
Page 121 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819544
Page 122 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Feb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819545
Page 123 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Feb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819546
Page 124 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Feb-08-2021 12:06:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819547
Page 125 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:39:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819548
Page 126 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-05-2021 10:39:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819549
Page 127 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-05-2021 10:39:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819550
Page 128 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-05-2021 10:39:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819551
Page 129 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-05-2021 10:39:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819552
Page 130 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-05-2021 10:39:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819553
Page 131 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-05-2021 10:39:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819554
Page 132 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:46:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819555
Page 133 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-05-2021 10:46:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819556
Page 134 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-05-2021 10:46:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819557
Page 135 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-05-2021 10:46:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819558
Page 136 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-05-2021 10:46:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819559
Page 137 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819560
Page 138 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819561
Page 139 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819562
Page 140 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819563
Page 141 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819564
Page 142 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819565
Page 143 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819566
Page 144 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819567
Page 145 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819568
Page 146 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819569
Page 147 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819570
Page 148 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819571
Page 149 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819572
Page 150 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819573
Page 151 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819574
Page 152 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819575
Page 153 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819576
Page 154 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819577
Page 155 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819578
Page 156 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819579
Page 157 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819580
Page 158 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819581
Page 159 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819582
Page 160 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819583
Page 161 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819584
Page 162 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819585
Page 163 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819586
Page 164 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819587
Page 165 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819588
Page 166 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819589
Page 167 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819590
Page 168 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819591
Page 169 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:47:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819592
Page 170 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819593
Page 171 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819594
Page 172 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819595
Page 173 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819596
Page 174 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819597
Page 175 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819598
Page 176 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819599
Page 177 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819600
Page 178 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819601
Page 179 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819602
Page 180 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819603
Page 181 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819604
Page 182 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819605
Page 183 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819606
Page 184 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819607
Page 185 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819608
Page 186 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819609
Page 187 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819610
Page 188 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819611
Page 189 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819612
Page 190 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819613
Page 191 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819614
Page 192 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819615
Page 193 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819616
Page 194 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819617
Page 195 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819618
Page 196 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819619
Page 197 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819620
Page 198 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819621
Page 199 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819622
Page 200 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819623
Page 201 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819624
Page 202 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819625
Page 203 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819626
Page 204 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819627
Page 205 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819628
Page 206 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819629
Page 207 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819630
Page 208 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819631
Page 209 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819632
Page 210 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819633
Page 211 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819634
Page 212 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819635
Page 213 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819636
Page 214 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jFeb-05-2021 10:47:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819637
Page 215 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:55:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819638
Page 216 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-05-2021 10:55:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
1Feb-05-2021 10:55:01 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819639
Page 217 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aFeb-05-2021 10:55:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819640
Page 218 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:55:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819641
Page 219 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-05-2021 10:55:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819642
Page 220 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-05-2021 10:55:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819643
Page 221 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-05-2021 10:55:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819644
Page 222 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:56:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819645
Page 223 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-05-2021 10:56:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819646
Page 224 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-05-2021 10:56:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819647
Page 225 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-05-2021 10:56:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819648
Page 226 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-05-2021 10:56:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819649
Page 227 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-05-2021 10:56:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819650
Page 228 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-05-2021 10:56:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819651
Page 229 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:56:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819652
Page 230 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-05-2021 10:56:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819653
Page 231 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-05-2021 10:56:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819654
Page 232 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-05-2021 10:56:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819655
Page 233 of 405
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: 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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-05-2021 10:56:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819656
Page 234 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormJan-11-2021 15:09:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819657
Page 235 of 405
***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: 11941002 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-12-2021 13:47:27 (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-11-2021 15:12:06 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich  Approved Mar-08-2021 08:47:17 (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 10:24:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819658
Page 236 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Andreas Eich  Approved Mar-02-2021 09:03:19 (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-26-2021 10:56:15 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich  Approved Feb-17-2021 08:44:23 (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 11:58:23 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich  Approved Feb-15-2021 08:42:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819659
Page 237 of 405
***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: 11941002 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-07-2021 09:49:39 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-06-2021 09:48:20 (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-01-2021 14:49:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich  Approved Jan-18-2021 10:36:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) 
(6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819660
Page 238 of 405
***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: 11941002 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-16-2021 13:30:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich  Approved Jan-12-2021 17:48:21 (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-08-2021 17:54:01 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich  Approved Dec-04-2020 11:00:53 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819661
Page 239 of 405
***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: 11941002 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 Dec-03-2020 15:49:20 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich  Approved Nov-09-2020 15:04:00 (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-05-2020 15:43:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Andreas Eich  Approved Oct-29-2020 16:33:24 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819662
Page 240 of 405
***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: 11941002 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.
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819663
Page 241 of 405
***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: 11941002 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-15-2020 16:51:01
(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-15-2020 16:51:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819664
Page 242 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-15-2020 16:51:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/15/2020Initial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819665
Page 243 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-15-2020 16:50:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11941002Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-16-2020
23:37:55
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clos
edAuto closed by
Validation Check:
VC_DM001_03
Oct-16-2020
13:09:37
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredChanged
Information
Oct-16-2020
13:09:37
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Data E
ntry:
UNK/U
NK/19
63Changed
Information
Oct-16-2020
11:54:57
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Open
edDMW4989006;Site
is in Germany or
South Africa,
however Date of
Birth is complete.
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0819666
Page 244 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-15-2020
17:42:05
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Data E
ntry:
/1
963Transcription Error
Oct-15-2020
16:50:40
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  auto calc (autocalc) Data E
ntry:
/1
973Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-15-2020 16:53:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-15-2020 16:53:59
(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-15-2020 16:53:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819667
Page 245 of 405
***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: 11941002 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-15-2020 16:55:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819668
Page 246 of 405
***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: 11941002 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-16-2020 09:39:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 09:39:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 09:39:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819669
Page 247 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Oct-16-2020 09:46:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Arterial Hypert
ension
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-16-2020 09:46:29
(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-16-2020 09:46:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Arterial HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-16-2020 09:46:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-16-2020 09:46:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819670
Page 248 of 405
***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: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.b
Date Location User Value Reason
Oct-16-2020 09:47:37
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Hyperlipidem
ia
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-16-2020 09:47:37
(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-16-2020 09:47:37
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
HyperlipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-16-2020 09:47:37
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-16-2020 09:47:37
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819671
Page 249 of 405
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-16-2020 09:47:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819672
Page 250 of 405
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
96.1Initial Entry
3. Unit:
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
190.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819673
Page 251 of 405
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.6Initial Entry
7.a
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Location:: EARInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-16-2020 09:48:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0819674
Page 252 of 405
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-16-2020 09:49:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-16-2020 09:49:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
269471Initial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819675
Page 253 of 405
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 09:49:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 09:49:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 19:20:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 12:59:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 09:49:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 09:49:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819676
Page 254 of 405
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a
Date Location User Value Reason
Oct-16-2020 19:20:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8HZHInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 19:20:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8HZHInitial Entry
5.b
Date Location User Value Reason
Oct-16-2020 19:21:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8HZJInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020 19:21:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8HZJInitial Entry
5.c
Date Location User Value Reason
Oct-16-2020 19:40:02
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNMD1WInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-16-2020 19:40:02
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNMD1WInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819677
Page 255 of 405
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.d
Date Location User Value Reason
Oct-16-2020 19:40:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNMD1XInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-16-2020 19:40:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNMD1XInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819678
Page 256 of 405
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 09:49:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 09:49:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 19:27:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 12:59:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 09:49:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 09:49:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819679
Page 257 of 405
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a
Date Location User Value Reason
Oct-16-2020 19:27:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8HZBInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 19:27:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8HZBInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819680
Page 258 of 405
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-16-2020 09:51:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 09:51:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020 09:51:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-16-2020 09:51:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020 13:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 09:51:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819681
Page 259 of 405
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-16-2020 09:51:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-16-2020 09:51:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020 09:51:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-16-2020 09:51:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819682
Page 260 of 405
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-16-2020 09:51:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3f18\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0819683
Page 261 of 405
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020 15:43:
…[truncated]