ID
34380
Description
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.
Keywords
Versions (1)
- 1/17/19 1/17/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 17, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)
End of Study Record
- StudyEvent: ODM
Description
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Description
If YES, complete the following.
Data type
boolean
Alias
- UMLS CUI [1]
- C3897431
Description
Date of subject unblinding event
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
Time of subject unblinding event
Data type
time
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0040223
Description
Reason of subject unblinding event
Data type
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Description
Specify 'Other' reason for subject unblinding event
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
Description
End of Study Record
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0444930
Description
Date of subject completion or discontinuation from the study
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0011008
Description
Time of subject completion or discontinuation from the study
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0040223
Description
premature discontinuation of study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C1279919
Description
Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2348577
- UMLS CUI [1,3]
- C1279919
Description
Specification reason for discontinuation
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C2348577
- UMLS CUI [1,4]
- C1279919
Description
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Description
Date of comment
Data type
date
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0011008
Description
CRF page number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C1516308
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0947611
Description
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
Description
Date of Investigator's signature
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator's signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name - print
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
End of Study Record
- StudyEvent: ODM
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,2])
C2348577 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C2348577 (UMLS CUI [1,3])
C1279919 (UMLS CUI [1,4])
C0947611 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1516308 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C1955348 (UMLS CUI-2)
C4288115 (UMLS CUI-3)
C2349182 (UMLS CUI-4)
C0011008 (UMLS CUI [1,2])