ID
34242
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
Mots-clés
Versions (1)
- 15/01/2019 15/01/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
15 janvier 2019
DOI
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Licence
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)
Laboratory Data
- StudyEvent: ODM
Description
Hematology Data
Alias
- UMLS CUI-1
- C0474523
Description
For GSK use only. This item has to be filled in only once for one session respectively one study day.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Description
This item has to be filled in only once for one session respectively one study day.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0474523
Description
This item has to be filled in only once for one session respectively one study day.
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0474523
Description
if NO, the following questions should not be answered. This item has to be filled in only once for one session respectively one study day.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
Description
Abnormal hematology parameters
Type de données
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0549193
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2985739
Description
This item has to be filled in only, if the previous question was answered YES.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
- UMLS CUI [1,4]
- C1549995
Description
Primary reason for hematology abnormality
Type de données
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
- UMLS CUI [1,4]
- C1549995
Description
Clinical Chemistry Data
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0243095
Description
For GSK use only. This item has to be filled in only once for one session respectively one study day.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Description
This item has to be filled in only once for one session respectively one study day.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0008000
Description
This item has to be filled in only once for one session respectively one study day.
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0008000
Description
if NO, the following questions should not be answered. This item has to be filled in only once for one session respectively one study day.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
Description
Abnormal clinical chemistry parameters
Type de données
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0549193
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2985739
Description
This item has to be filled in only, if the previous question was answered YES.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
- UMLS CUI [1,4]
- C1549995
Description
Primary reason for clinical chemistry abnormality
Type de données
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
- UMLS CUI [1,4]
- C1549995
Description
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
This item has to be filled in only once for one session respectively one study day.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0042014
Description
This item has to be filled in only once for one session respectively one study day.
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0042014
Description
if NO, the following questions should not be answered. This item has to be filled in only once for one session respectively one study day.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
Description
Abnormal dip-sticks parameters
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1160927
- UMLS CUI [1,3]
- C0549193
- UMLS CUI [1,4]
- C1704258
- UMLS CUI [1,5]
- C2985739
Description
This item has to be filled in only, if the previous question was answered YES.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1160927
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2985739
- UMLS CUI [1,5]
- C1549995
Description
Primary reason for urinalysis abnormality in dip-sticks
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1160927
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2985739
- UMLS CUI [1,5]
- C1549995
Description
Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2700128
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
Description
Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2700128
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2985739
- UMLS CUI [1,5]
- C1549995
Description
Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2700128
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2985739
- UMLS CUI [1,5]
- C1549995
Similar models
Laboratory Data
- StudyEvent: ODM
C0805701 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C0549193 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
C0243095 (UMLS CUI-2)
C0805701 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C0549193 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1160927 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
C2985739 (UMLS CUI [1,5])
C1160927 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
C1160927 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C2700128 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
C2700128 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])