ID

23011

Description

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

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  1. 19/06/2017 19/06/2017 -
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19 juin 2017

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Subject Diary Card (Washout period) - GSK Milveterol COPD 100527

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Subject Diary Card (Washout period) - GSK Milveterol COPD 100527

1 Formulaires  
Subject Diary Card - Washout period
Description

Subject Diary Card - Washout period

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1710661
Washout period
Description

Washout period

Type de données

integer

Alias
UMLS CUI [1]
C1710661
Washout day
Description

Washout day

Type de données

integer

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0439228
Date
Description

Date

Type de données

date

Unités de mesure
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0011008
dd.mm.yyyy
Pre-Dose PEFR (Peak flow measurement is to be performed 3 times in the morning before 10.00 am. Record the highest PEFR value.)
Description

Pre-Dose PEFR

Type de données

integer

Unités de mesure
  • L/min
Alias
UMLS CUI [1,1]
C0030735
UMLS CUI [1,2]
C0332170
L/min
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.)
Description

12 h Post-Dose PEFR

Type de données

integer

Unités de mesure
  • L/min
Alias
UMLS CUI [1,1]
C0030735
UMLS CUI [1,2]
C0587117
L/min
Rescue Medication (lpratropium bromide): Record the time taken during the day
Description

Rescue Medication: Time

Type de données

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0884980
UMLS CUI [1,3]
C0700580
Rescue Medication (lpratropium bromide): Record number of capsules taken at timepoint
Description

Rescue Medication: Number of Capsules at timepoint

Type de données

integer

Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C1706433
UMLS CUI [1,3]
C0884980
UMLS CUI [1,4]
C0700580
UMLS CUI [1,5]
C2348792
Rescue Medication (lpratropium bromide): Record total number of capsules taken during the day
Description

Rescue Medication: Total number of capsules taken

Type de données

integer

Alias
UMLS CUI [1,1]
C4288115
UMLS CUI [1,2]
C1706433
UMLS CUI [1,3]
C0439505
UMLS CUI [1,4]
C0884980
UMLS CUI [1,5]
C0700580
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Similar models

Subject Diary Card (Washout period) - GSK Milveterol COPD 100527

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Subject Diary Card - Washout period
C3890583 (UMLS CUI-1)
C1710661 (UMLS CUI-2)
Item
Washout period
integer
C1710661 (UMLS CUI [1])
Washout period
Code List
Washout period
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
Washout day
integer
C1710661 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Treatment period
Code List
Washout day
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])
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])
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])
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])
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])
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