ID
34242
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
Stichworte
Versionen (1)
- 15.01.19 15.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
15. Januar 2019
DOI
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Lizenz
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
Beschreibung
Hematology Data
Alias
- UMLS CUI-1
- C0474523
Beschreibung
For GSK use only. This item has to be filled in only once for one session respectively one study day.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Beschreibung
This item has to be filled in only once for one session respectively one study day.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0474523
Beschreibung
This item has to be filled in only once for one session respectively one study day.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0474523
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
Beschreibung
Abnormal hematology parameters
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0549193
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2985739
Beschreibung
This item has to be filled in only, if the previous question was answered YES.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
- UMLS CUI [1,4]
- C1549995
Beschreibung
Primary reason for hematology abnormality
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
- UMLS CUI [1,4]
- C1549995
Beschreibung
Clinical Chemistry Data
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0243095
Beschreibung
For GSK use only. This item has to be filled in only once for one session respectively one study day.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Beschreibung
This item has to be filled in only once for one session respectively one study day.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0008000
Beschreibung
This item has to be filled in only once for one session respectively one study day.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0008000
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
Beschreibung
Abnormal clinical chemistry parameters
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0549193
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2985739
Beschreibung
This item has to be filled in only, if the previous question was answered YES.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
- UMLS CUI [1,4]
- C1549995
Beschreibung
Primary reason for clinical chemistry abnormality
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
- UMLS CUI [1,4]
- C1549995
Beschreibung
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschreibung
This item has to be filled in only once for one session respectively one study day.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0042014
Beschreibung
This item has to be filled in only once for one session respectively one study day.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0042014
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
Beschreibung
Abnormal dip-sticks parameters
Datentyp
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
Beschreibung
This item has to be filled in only, if the previous question was answered YES.
Datentyp
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
Beschreibung
Primary reason for urinalysis abnormality in dip-sticks
Datentyp
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
Beschreibung
Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2700128
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2985739
Beschreibung
Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.
Datentyp
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
Beschreibung
Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.
Datentyp
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
Ähnliche Modelle
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])