ID
23001
Beschrijving
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive
Trefwoorden
Versies (3)
- 19-06-17 19-06-17 -
- 19-06-17 19-06-17 -
- 20-09-21 20-09-21 -
Geüploaded op
19 juni 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Follow-up - GSK Milveterol COPD 100527
Follow-up - GSK Milveterol COPD 100527
- StudyEvent: ODM
Beschrijving
12-Lead Electrocardiogram (Follow-up)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1522577
Beschrijving
Sequence number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0430456
Beschrijving
Date of ECG
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826640
Beschrijving
Time relative to dosing
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beschrijving
Time of ECG
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschrijving
Ventricular rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
QT Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0577807
Beschrijving
QTc Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0855331
Beschrijving
ECG finding
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
ECG abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2985739
Beschrijving
Hematology Data (Follow-up)
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C1522577
Beschrijving
Lab code
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Beschrijving
Date hematology sample taken
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0474523
Beschrijving
Time of blood sample
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0474523
- UMLS CUI [1,3]
- C0040223
Beschrijving
Hematology abnormality
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0850715
- UMLS CUI [1,2]
- C2985739
Beschrijving
Hematology test
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0332307
Beschrijving
Hematology test result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0587081
Beschrijving
clinically significant abnormality reason
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
- UMLS CUI [1,3]
- C0566251
Beschrijving
Clinical Chemistry Data (Follow-up)
Alias
- UMLS CUI-1
- C2347783
- UMLS CUI-2
- C1522577
Beschrijving
Lab code
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Beschrijving
Date clinical chemistry sample taken
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0008000
Beschrijving
Time of sample
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0008000
Beschrijving
clinically significant clinical chemistry abnormalities
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2985739
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C1704258
Beschrijving
Clinical chemistry test
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0525044
- UMLS CUI [1,2]
- C0332307
Beschrijving
Clinical chemistry test result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Beschrijving
clinically significant abnormality reason
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
- UMLS CUI [1,3]
- C0566251
Beschrijving
Urinalysis (Follow-up)
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C1522577
Beschrijving
Lab code
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Beschrijving
Date sample taken
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0042036
Beschrijving
Time sample taken
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0042036
Beschrijving
clinically significant urinalysis abnormalities
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2985739
- UMLS CUI [1,3]
- C1704258
Beschrijving
Urinalysis dipstick
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0332307
Beschrijving
Dipstick test result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0587081
Beschrijving
clinically significant abnormality reason
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
- UMLS CUI [1,3]
- C0566251
Beschrijving
Sedimentary microscopy test
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2700128
- UMLS CUI [1,2]
- C0332307
Beschrijving
Sedimentary microscopy test result
Datatype
float
Alias
- UMLS CUI [1,1]
- C2700128
- UMLS CUI [1,2]
- C0587081
Beschrijving
clinically significant abnormality reason
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
- UMLS CUI [1,3]
- C0566251
Similar models
Follow-up - GSK Milveterol COPD 100527
- StudyEvent: ODM
C1522577 (UMLS CUI-2)
C0518766 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0430456 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0013798 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0805701 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
C0474523 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1522577 (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])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0587081 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])