ID
22991
Beschreibung
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
Stichworte
Versionen (2)
- 19.06.17 19.06.17 -
- 20.09.21 20.09.21 -
Hochgeladen am
19. Juni 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Main CRF (Treatment Period 4, Day 3-6) - GSK Milveterol COPD 100527
Main CRF (Treatment Period 4, Day 3-6) - GSK Milveterol COPD 100527
Beschreibung
12-Lead Electrocardiogram (Treatment period 4, Day 3-6)
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Sequence number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0430456
Beschreibung
Date of ECG
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826640
Beschreibung
Study day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
Time relative to dosing
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beschreibung
Time of ECG
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschreibung
Ventricular rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschreibung
QT Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0577807
Beschreibung
QTc Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0855331
Beschreibung
ECG finding
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
ECG abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2985739
Beschreibung
FEV1 (Treatment Period 4, Day 3-6)
Alias
- UMLS CUI-1
- C0429706
Beschreibung
Sequence number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0429706
Beschreibung
Date of FEV1
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
Beschreibung
Study day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
Time relative to dosing
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beschreibung
Time of FEV1 measurement
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beschreibung
Reading 1
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Beschreibung
Reading 2
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Beschreibung
Pharmacokinetic sampling (Treatment Period 4, Day 5-6)
Alias
- UMLS CUI-1
- C0201734
Beschreibung
Sequence number pharmacokinetic study
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0201734
Beschreibung
Date of pharmacokinetic study
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0201734
Beschreibung
Study day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
Time relative to dosing
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beschreibung
Time of pharmacokinetic study
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0201734
Beschreibung
Sample number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0201734
Beschreibung
Blood sample taken
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1277698
Beschreibung
Potassium (Treatment Period 4, Day 5-6)
Alias
- UMLS CUI-1
- C0202194
Beschreibung
Sequence number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0202194
Beschreibung
Date of measurement
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0202194
Beschreibung
Study day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
Time relative to dosing
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beschreibung
Time of measurement
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0202194
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0337438
Beschreibung
Test result
Datentyp
float
Maßeinheiten
- mmol/L
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0202194
Beschreibung
Investigational Product (Treatment period 4, Day 3-6)
Alias
- UMLS CUI-1
- C0304229
Beschreibung
Date of dose
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschreibung
Study day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
Start time of inhalation
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Beschreibung
End time of inhalation
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Beschreibung
investigational product change of administration
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0443172
Beschreibung
Specification investigational product change of administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C3469597
- UMLS CUI [1,4]
- C0443172
Ähnliche Modelle
Main CRF (Treatment Period 4, Day 3-6) - GSK Milveterol COPD 100527
C0518766 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
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])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
C0202194 (UMLS CUI [1,2])
C0202194 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0202194 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
C0202194 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0001559 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])