Informatie:
Fout:
ID
23010
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 (2)
- 19-06-17 19-06-17 -
- 19-06-17 19-06-17 -
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19 juni 2017
DOI
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Creative Commons BY-NC 3.0
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Subject Diary Card (Treatment period) - GSK Milveterol COPD 100527
Subject Diary Card (Treatment period) - GSK Milveterol COPD 100527
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Subject Diary Card (Treatment period) - GSK Milveterol COPD 100527
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Subject Diary Card - Treatment period
C3890583 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1948053 (UMLS CUI-3)
C0087111 (UMLS CUI-2)
C1948053 (UMLS CUI-3)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Pre-Dose PEFR
Item
Pre-Dose PEFR (Peak flow measurement is to be performed 3 times in the morning before taking study drug. Record the highest PEFR value.)
integer
C0030735 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
12 h Post-Dose PEFR
Item
12 h Post-Dose PEFR (Peak flow measurement is to be performed 3 times in the evening 12hrs after taking study drug. Record the highest PEFR value.)
integer
C0030735 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Rescue Medication: Time
Item
Rescue Medication (lpratropium bromide): Record the time taken during the day
time
C0040223 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
C0700580 (UMLS CUI [1,3])
C0884980 (UMLS CUI [1,2])
C0700580 (UMLS CUI [1,3])
Rescue Medication: Number of Capsules at timepoint
Item
Rescue Medication (lpratropium bromide): Record number of capsules taken at timepoint
integer
C1265611 (UMLS CUI [1,1])
C1706433 (UMLS CUI [1,2])
C0884980 (UMLS CUI [1,3])
C0700580 (UMLS CUI [1,4])
C2348792 (UMLS CUI [1,5])
C1706433 (UMLS CUI [1,2])
C0884980 (UMLS CUI [1,3])
C0700580 (UMLS CUI [1,4])
C2348792 (UMLS CUI [1,5])
Rescue Medication: Total number of capsules taken
Item
Rescue Medication (lpratropium bromide): Record total number of capsules taken during the day
integer
C4288115 (UMLS CUI [1,1])
C1706433 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0884980 (UMLS CUI [1,4])
C0700580 (UMLS CUI [1,5])
C1706433 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0884980 (UMLS CUI [1,4])
C0700580 (UMLS CUI [1,5])