ID

34380

Beschreibung

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive.

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  1. 17.01.19 17.01.19 -
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GlaxoSmithKline

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17. Januar 2019

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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

Englisch

End of Study Record

1 Formulare  
  1. StudyEvent: ODM
    1. End of Study Record
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Status of treatment blind
Beschreibung

Status of treatment blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind for this subject broken during the study?
Beschreibung

If YES, complete the following.

Datentyp

boolean

Alias
UMLS CUI [1]
C3897431
Date of subject unblinding event
Beschreibung

Date of subject unblinding event

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Time of subject unblinding event
Beschreibung

Time of subject unblinding event

Datentyp

time

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason of subject unblinding event
Beschreibung

Reason of subject unblinding event

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
If answer 'Other' was choosen as reason for subject unblinding event, specify:
Beschreibung

Specify 'Other' reason for subject unblinding event

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205394
End of Study Record
Beschreibung

End of Study Record

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0444930
Date of subject completion or discontinuation from the study
Beschreibung

Date of subject completion or discontinuation from the study

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0011008
dd.mm.yyyy
Time of subject completion or discontinuation from the study
Beschreibung

Time of subject completion or discontinuation from the study

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0040223
hh:mm
Did the subject discontinue the study prematurely?
Beschreibung

premature discontinuation of study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C1279919
If 'Yes', the primary reason for discontinuation:
Beschreibung

Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2348577
UMLS CUI [1,3]
C1279919
If 'Other', please specify:
Beschreibung

Specification reason for discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C2348577
UMLS CUI [1,4]
C1279919
Investigator Comment Log
Beschreibung

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Date of comment
Beschreibung

Date of comment

Datentyp

date

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0011008
CRF page number if applicable
Beschreibung

CRF page number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0947611
Investigator's statement: I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
Beschreibung

Investigator's statement: I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.

Alias
UMLS CUI-1
C1516308
UMLS CUI-2
C1955348
UMLS CUI-3
C4288115
UMLS CUI-4
C2349182
Date of Investigator's signature
Beschreibung

Date of Investigator's signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's signature
Beschreibung

Investigator's signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's name - print
Beschreibung

Investigator's name - print

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

End of Study Record

1 Formulare
  1. StudyEvent: ODM
    1. End of Study Record
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Status of treatment blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Was the treatment blind for this subject broken during the study?
Item
Was the treatment blind for this subject broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date of subject unblinding event
Item
Date of subject unblinding event
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of subject unblinding event
Item
Time of subject unblinding event
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason of subject unblinding event
integer
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason of subject unblinding event
Code List
Reason of subject unblinding event
CL Item
Medical emergency requiring identity of investigational product for further treatment  (1)
CL Item
Other (2)
Specify 'Other' reason for subject unblinding event
Item
If answer 'Other' was choosen as reason for subject unblinding event, specify:
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
End of Study Record
C0008976 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Date of subject completion or discontinuation from the study
Item
Date of subject completion or discontinuation from the study
date
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of subject completion or discontinuation from the study
Item
Time of subject completion or discontinuation from the study
time
C2348577 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
premature discontinuation of study
Item
Did the subject discontinue the study prematurely?
boolean
C2348577 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
Item
If 'Yes', the primary reason for discontinuation:
integer
C0566251 (UMLS CUI [1,1])
C2348577 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
Reason for premature discontinuation
Code List
If 'Yes', the primary reason for discontinuation:
CL Item
Adverse event (1)
CL Item
Consent withdrawn (2)
CL Item
Lost to follow up (3)
CL Item
Protocol violation (4)
CL Item
Other (please specify below) (5)
Specification reason for discontinuation
Item
If 'Other', please specify:
text
C2348235 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2348577 (UMLS CUI [1,3])
C1279919 (UMLS CUI [1,4])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CRF page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0008961 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator's statement: I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
C1516308 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
C4288115 (UMLS CUI-3)
C2349182 (UMLS CUI-4)
Date of Investigator's signature
Item
Date of Investigator's signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name - print
Item
Investigator's name - print
text
C2826892 (UMLS CUI [1])
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