Information:
Fel:
ID
23011
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-06-19 2017-06-19 -
Uppladdad den
19 juni 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Subject Diary Card (Washout period) - GSK Milveterol COPD 100527
Subject Diary Card (Washout period) - GSK Milveterol COPD 100527
- StudyEvent: ODM
Similar models
Subject Diary Card (Washout period) - GSK Milveterol COPD 100527
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Subject Diary Card - Washout period
C3890583 (UMLS CUI-1)
C1710661 (UMLS CUI-2)
C1710661 (UMLS CUI-2)
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)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
CL Item
26 (26)
CL Item
27 (27)
CL Item
28 (28)
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 10.00 am. Record the highest PEFR value.)
integer
C0030735 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,2])
12 h Post-Dose PEFR
Item
12 h Post-Dose PEFR (Peak flow measurement is to be performed 3 times in the evening after 6.00pm. Record the highest PEFR value.)
integer
C0030735 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,2])
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])