ID

23010

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

Mots-clés

Versions (2)
  1. 19/06/2017 19/06/2017 -
  2. 19/06/2017 19/06/2017 -
Téléchargé le

19 juin 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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Subject Diary Card (Treatment period) - GSK Milveterol COPD 100527

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

1 Formulaires  
Subject Diary Card - Treatment period
Description

Subject Diary Card - Treatment period

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0087111
UMLS CUI-3
C1948053
Treatment period
Description

Treatment period

Type de données

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1948053
Study day
Description

Study day

Type de données

integer

Alias
UMLS CUI [1]
C2826182
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 taking study drug. 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]
C0332152
UMLS CUI [1,3]
C0304229
L/min
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.)
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]
C0687676
UMLS CUI [1,3]
C0304229
L/min
Rescue Medication (lpratropium bromide): Record the time taken during the day
Description

Rescue Medication: Time

Type de données

time

Unités de mesure
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0884980
UMLS CUI [1,3]
C0700580
hh:mm
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 (Treatment period) - GSK Milveterol COPD 100527

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Subject Diary Card - Treatment period
C3890583 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1948053 (UMLS CUI-3)
Item
Treatment period
integer
C0087111 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Treatment period
Code List
Treatment period
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study day
Code List
Study 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)
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])
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])
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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