ID
34364
Beschrijving
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. This form contains information about non-serious adverse events and should only be completed in case of occurence of non-serious adverse events.
Trefwoorden
Versies (2)
- 16-01-19 16-01-19 -
- 16-01-19 16-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 januari 2019
DOI
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Licentie
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)
Non-Serious Adverse Events
- StudyEvent: ODM
Beschrijving
Non-Serious adverse events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
If YES, indicate below
Datatype
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Diagnosis or signs/symptoms of NSAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0037088
- UMLS CUI [1,3]
- C1518404
Beschrijving
Date of onset NSAE
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1518404
Beschrijving
Time of onset NSAE
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1518404
Beschrijving
Maximum Intensity NSAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1518404
Beschrijving
Outcome SAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1518404
Beschrijving
Date of resolution
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C2985918
- UMLS CUI [1,2]
- C1518404
Beschrijving
Time of resolution
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C1518404
Beschrijving
Investigational drug, change of dose as a result of NSAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1608430
- UMLS CUI [1,3]
- C1518404
Beschrijving
Withdrawal from study as result of NSAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschrijving
Relationship to investigational product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0013230
Beschrijving
In this study, the answer 'No' was preselected.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704788
- UMLS CUI [1,2]
- C1710056
Similar models
Non-Serious Adverse Events
- StudyEvent: ODM
C0037088 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C2699488 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1608430 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1710056 (UMLS CUI [1,2])