Document text
Page 1 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819829
Page 2 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/16/2020
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819830
Page 3 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11941033]
2.Birth Date: UNK/UNK/1974
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
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(b) (4)
FDA-CBER-2021-5683-0819831
Page 4 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819832
Page 5 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819833
Page 6 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819834
Page 7 of 650
***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: 11941033 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/2018
Ongoing: YES
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819835
Page 8 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819836
Page 9 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
2.Weight: [95.9]
3.Unit: kg
4.Height: [164.0]
5.Unit: cm
6.Body Mass Index: [35.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: EAR
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819837
Page 10 of 650
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/16/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819838
Page 11 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/16/2020
2.Randomization Number: [109061]
3.Randomization Group: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819839
Page 12 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8J2J]
5.bSample ID [BN8J2K]
5.cSample ID [BNMD3Y]
5.dSample ID [BNMD3Z]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819840
Page 13 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8J28]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819841
Page 14 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/16/2020 19:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819842
Page 15 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819843
Page 16 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819844
Page 17 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819845
Page 18 of 650
***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: 11941033 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: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819846
Page 19 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: EAR
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819847
Page 20 of 650
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/6/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819848
Page 21 of 650
***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: 11941033 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/6/2020
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 [BN8HM0]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819849
Page 22 of 650
***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: 11941033 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/6/2020 09:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819850
Page 23 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819851
Page 24 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819852
Page 25 of 650
***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: 11941033 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: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819853
Page 26 of 650
***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: 11941033 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/4/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8HSK]
5.bSample ID [BN8HSL]
5.cSample ID [BNMDB2]
5.dSample ID [BNMDB3]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819854
Page 27 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819855
Page 28 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/21/2020
2.Date of First Symptom Started: Dec/20/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/22/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819856
Page 29 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819857
Page 30 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/21/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819858
Page 31 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/21/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ROCHE MOLECULAR SYSTEMS COBAS SARS-COV-2
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819859
Page 32 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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 [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819860
Page 33 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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:
Dec/21/2020
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 [BN15B7]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819861
Page 34 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819862
Page 35 of 650
***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: 11941033 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 Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819863
Page 36 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819864
Page 37 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819865
Page 38 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819866
Page 39 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819867
Page 40 of 650
***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: 11941033 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 Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819868
Page 41 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819869
Page 42 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819870
Page 43 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819871
Page 44 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819872
Page 45 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819873
Page 46 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819874
Page 47 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819875
Page 48 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819876
Page 49 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819877
Page 50 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819878
Page 51 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819879
Page 52 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Dec/21/2020 Record Identifier: Systolic: Diastolic:
1 128 79 Repeating Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819880
Page 53 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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: Dec/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [128]
Diastolic: [79]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [71]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819881
Page 54 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Dec/21/2020 Record Identifier: Oxygen Saturation
1 99.0 Repeating Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819882
Page 55 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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: Dec/21/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819883
Page 56 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819884
Page 57 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819885
Page 58 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819886
Page 59 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819887
Page 60 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819888
Page 61 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819889
Page 62 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819890
Page 63 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/3/2021
2.Date of First Symptom Started: Feb/2/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/6/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819891
Page 64 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819892
Page 65 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 11941033 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 Type Form Instance
1.Not Applicable Not Applicab
le Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819893
Page 66 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819894
Page 67 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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? YES
Date of Collection:
Feb/5/2021
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 [RR07298]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819895
Page 68 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[telephon contact]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819896
Page 69 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819897
Page 70 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 11941033 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 Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819898
Page 71 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819899
Page 72 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819900
Page 73 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819901
Page 74 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819902
Page 75 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 11941033 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 Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819903
Page 76 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819904
Page 77 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819905
Page 78 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819906
Page 79 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819907
Page 80 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819908
Page 81 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819909
Page 82 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819910
Page 83 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819911
Page 84 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819912
Page 85 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819913
Page 86 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819914
Page 87 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819915
Page 88 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819916
Page 89 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819917
Page 90 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819918
Page 91 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819919
Page 92 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819920
Page 93 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819921
Page 94 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819922
Page 95 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819923
Page 96 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819924
Page 97 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/12/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819925
Page 98 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/12/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Sample collected on 12.Jan2021 as part of V101.] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN15CW]
5.bSample ID [BN15CX]
5.cSample ID [BNMPKH]
5.dSample ID [BNMPKJ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819926
Page 99 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Mar/05/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819927
Page 100 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Mar/05/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 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/5/2021
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 [BN15LH]
5.bSample ID [BN15LJ]
5.cSample ID [BNMPNF]
5.dSample ID [BNMPNG]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819928
Page 101 of 650
***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: 11941033 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:
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819929
Page 102 of 650
***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: 11941033 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 [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819930
Page 103 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Pain at injection site Jan/12/2021 19:0
0 NO
End Date Time:
Jan/14/2021 23:00
Repeating
Pages
2.ADVERSE EV
ENT 2 Lymphadenopathia (axi
llar left) Feb/4/2021 UNK
:UNK NO
End Date Time:
Feb/6/2021 20:00
Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819931
Page 104 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pain at injection site]
4.Start Date Time: Jan/12/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 23:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819932
Page 105 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819933
Page 106 of 650
***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: 11941033 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)[Lymphadenopathia (axillar left)]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/6/2021 20:00
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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819934
Page 107 of 650
***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: 11941033 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[ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819935
Page 108 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819936
Page 109 of 650
***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: 11941033 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[ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819937
Page 110 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819938
Page 111 of 650
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819939
Page 112 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819940
Page 113 of 650
***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: 11941033 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?
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819941
Page 114 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819942
Page 115 of 650
***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: 11941033 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?
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819943
Page 116 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819944
Page 117 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819945
Page 118 of 650
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/03/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819946
Page 119 of 650
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/03/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819947
Page 120 of 650
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/03/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/3/2021
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Vaccination Reaction:
enlarged lymph nodes (moderate), Fever (38.2), Chills (moderate)]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819948
Page 121 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819949
Page 122 of 650
***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: 11941033 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:
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819950
Page 123 of 650
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819951
Page 124 of 650
***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: 11941033 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?
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819952
Page 125 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819953
Page 126 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819954
Page 127 of 650
***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: 11941033 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/4/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819955
Page 128 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819956
Page 129 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819957
Page 130 of 650
***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: 11941033 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: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819958
Page 131 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819959
Page 132 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/12/2021
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819960
Page 133 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819961
Page 134 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/12/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819962
Page 135 of 650
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/12/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819963
Page 136 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Compined with cov conv]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
5.dSample ID [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819964
Page 137 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN15CV]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819965
Page 138 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/12/2021 14:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819966
Page 139 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819967
Page 140 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819968
Page 141 of 650
***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: 11941033 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: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819969
Page 142 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819970
Page 143 of 650
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1194 Site Name: (1194) IKF Pneumologie GmbH Co KG, Institut fuer
klinische Forschung
Subject No: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/2/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819971
Page 144 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN15J0]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819972
Page 145 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/2/2021 09:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819973
Page 146 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819974
Page 147 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/2/2021
3.Comments: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819975
Page 148 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819976
Page 149 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819977
Page 150 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819978
Page 151 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819979
Page 152 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/2/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819980
Page 153 of 650
***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: 11941033 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/4/2020
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819981
Page 154 of 650
***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: 11941033 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
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819982
Page 155 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Andreas Eich Approved Mar-10-2021 11:19:20 (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.
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819983
Page 156 of 650
***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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-19-2020 11:38:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819984
Page 157 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-21-2020 10:52:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819985
Page 158 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-21-2020 10:52:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819986
Page 159 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Dec-21-2020 10:52:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819987
Page 160 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Dec-21-2020 10:52:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819988
Page 161 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Dec-21-2020 10:52:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819989
Page 162 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Dec-21-2020 10:52:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819990
Page 163 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Dec-21-2020 10:52:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819991
Page 164 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-21-2020 10:54:53 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819992
Page 165 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-21-2020 10:54:53 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819993
Page 166 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Dec-21-2020 10:54:53 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819994
Page 167 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Dec-21-2020 10:54:53 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819995
Page 168 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Dec-21-2020 10:54:53 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819996
Page 169 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819997
Page 170 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819998
Page 171 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Dec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819999
Page 172 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Dec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820000
Page 173 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Dec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820001
Page 174 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820002
Page 175 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820003
Page 176 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820004
Page 177 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820005
Page 178 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820006
Page 179 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820007
Page 180 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820008
Page 181 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820009
Page 182 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820010
Page 183 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820011
Page 184 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820012
Page 185 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820013
Page 186 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820014
Page 187 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820015
Page 188 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820016
Page 189 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820017
Page 190 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820018
Page 191 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820019
Page 192 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820020
Page 193 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820021
Page 194 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820022
Page 195 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820023
Page 196 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820024
Page 197 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820025
Page 198 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820026
Page 199 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820027
Page 200 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820028
Page 201 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gDec-21-2020 10:55:19 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820029
Page 202 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820030
Page 203 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820031
Page 204 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Dec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820032
Page 205 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Dec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820033
Page 206 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Dec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820034
Page 207 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820035
Page 208 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820036
Page 209 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820037
Page 210 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820038
Page 211 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820039
Page 212 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820040
Page 213 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820041
Page 214 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820042
Page 215 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820043
Page 216 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820044
Page 217 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820045
Page 218 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820046
Page 219 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820047
Page 220 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820048
Page 221 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820049
Page 222 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820050
Page 223 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820051
Page 224 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820052
Page 225 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820053
Page 226 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820054
Page 227 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820055
Page 228 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820056
Page 229 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820057
Page 230 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820058
Page 231 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820059
Page 232 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820060
Page 233 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820061
Page 234 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820062
Page 235 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820063
Page 236 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820064
Page 237 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820065
Page 238 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820066
Page 239 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820067
Page 240 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820068
Page 241 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820069
Page 242 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820070
Page 243 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820071
Page 244 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820072
Page 245 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820073
Page 246 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jDec-21-2020 10:55:47 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820074
Page 247 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-22-2020 10:24:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820075
Page 248 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-22-2020 10:24:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820076
Page 249 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Dec-22-2020 10:24:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820077
Page 250 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Dec-22-2020 10:24:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Done
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820078
Page 251 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-22-2020 10:24:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820079
Page 252 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-22-2020 10:24:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820080
Page 253 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Dec-22-2020 10:24:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820081
Page 254 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Dec-22-2020 10:24:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820082
Page 255 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Dec-22-2020 10:24:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820083
Page 256 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Dec-22-2020 10:24:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820084
Page 257 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Dec-22-2020 10:24:29 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820085
Page 258 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-22-2020 10:24:48 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820086
Page 259 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-22-2020 10:24:48 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820087
Page 260 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Dec-22-2020 10:24:48 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820088
Page 261 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Dec-22-2020 10:24:48 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820089
Page 262 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Dec-22-2020 10:24:48 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820090
Page 263 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820091
Page 264 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820092
Page 265 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820093
Page 266 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820094
Page 267 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820095
Page 268 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820096
Page 269 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820097
Page 270 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Feb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820098
Page 271 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Feb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820099
Page 272 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Feb-10-2021 14:24:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820100
Page 273 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-11-2021 11:23:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820101
Page 274 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-11-2021 11:23:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820102
Page 275 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-11-2021 11:23:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820103
Page 276 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-11-2021 11:23:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820104
Page 277 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-11-2021 11:23:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820105
Page 278 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-11-2021 11:23:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820106
Page 279 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-11-2021 11:23:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820107
Page 280 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-10-2021 14:30:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f1a\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0820108
Page 281 of 650
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/03/2021Form: 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: 11941033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-10-2021 14:30:44 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
09
…[truncated]