ID
34380
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.
Trefwoorden
Versies (1)
- 17-01-19 17-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 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)
End of Study Record
- StudyEvent: ODM
Beschrijving
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschrijving
If YES, complete the following.
Datatype
boolean
Alias
- UMLS CUI [1]
- C3897431
Beschrijving
Date of subject unblinding event
Datatype
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschrijving
Time of subject unblinding event
Datatype
time
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0040223
Beschrijving
Reason of subject unblinding event
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Beschrijving
Specify 'Other' reason for subject unblinding event
Datatype
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
Beschrijving
End of Study Record
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0444930
Beschrijving
Date of subject completion or discontinuation from the study
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0011008
Beschrijving
Time of subject completion or discontinuation from the study
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0040223
Beschrijving
premature discontinuation of study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C1279919
Beschrijving
Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2348577
- UMLS CUI [1,3]
- C1279919
Beschrijving
Specification reason for discontinuation
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C2348577
- UMLS CUI [1,4]
- C1279919
Beschrijving
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Beschrijving
Date of comment
Datatype
date
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0011008
Beschrijving
CRF page number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C1516308
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0947611
Beschrijving
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
Beschrijving
Date of Investigator's signature
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator's signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator's name - print
Datatype
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])