ID
34117
Description
Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive. This form contains information about lung function tests during screening procedure. It has to be filled in in Session 1.
Mots-clés
Versions (1)
- 14/01/2019 14/01/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
14 janvier 2019
DOI
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Licence
Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)
Lung function tests: Screening
- StudyEvent: ODM
Description
Screening
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0220908
Description
Row number
Type de données
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024119
Description
Lung function test. Each test should be performed during screening procedure.
Type de données
text
Alias
- UMLS CUI [1]
- C0748133
- UMLS CUI [2,1]
- C0024119
- UMLS CUI [2,2]
- C1287681
- UMLS CUI [3,1]
- C0024119
- UMLS CUI [3,2]
- C0429745
Description
Actual time of first reading
Type de données
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0024119
Description
Reading 1
Type de données
float
Alias
- UMLS CUI [1]
- C0242485
Description
Reading 2
Type de données
float
Alias
- UMLS CUI [1]
- C0242485
Description
Reading 3
Type de données
float
Alias
- UMLS CUI [1]
- C0242485
Description
According to form, highest reading should only be filled in for FEV1 and FVC. In this study, highest reading should not be entered anywhere.
Type de données
float
Alias
- UMLS CUI [1,1]
- C1522410
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0748133
- UMLS CUI [2,1]
- C1522410
- UMLS CUI [2,2]
- C0456984
- UMLS CUI [2,3]
- C1287681
Description
Predicted normal should only be filled in for FEV1.
Type de données
float
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
Description
According to form, Percent predicted normal should only be filled in for FEV1. To obtain this value, divide 'Highest reading' by 'Predicted normal' and multiply with 100. In this study, Percent predicted normal should not be entered anywhere.
Type de données
float
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0439165
Description
In this study, FEV1/FVC ratio should not be entered.
Type de données
float
Alias
- UMLS CUI [1,1]
- C0429745
- UMLS CUI [1,2]
- C0456603
Description
According to form: If NO, EXCLUDE subject from the study. In this study, this question should not bei answered.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0439165
- UMLS CUI [2]
- C0429745
Similar models
Lung function tests: Screening
- StudyEvent: ODM
C0024119 (UMLS CUI [1,2])
C0024119 (UMLS CUI [2,1])
C1287681 (UMLS CUI [2,2])
C0024119 (UMLS CUI [3,1])
C0429745 (UMLS CUI [3,2])
C0242485 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
C0456984 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
C1522410 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C1287681 (UMLS CUI [2,3])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0456603 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0429745 (UMLS CUI [2])