ID
34117
Beschrijving
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.
Trefwoorden
Versies (1)
- 14-01-19 14-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
14 januari 2019
DOI
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Licentie
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
Beschrijving
Screening
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0220908
Beschrijving
Row number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024119
Beschrijving
Lung function test. Each test should be performed during screening procedure.
Datatype
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
Beschrijving
Actual time of first reading
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0024119
Beschrijving
Reading 1
Datatype
float
Alias
- UMLS CUI [1]
- C0242485
Beschrijving
Reading 2
Datatype
float
Alias
- UMLS CUI [1]
- C0242485
Beschrijving
Reading 3
Datatype
float
Alias
- UMLS CUI [1]
- C0242485
Beschrijving
According to form, highest reading should only be filled in for FEV1 and FVC. In this study, highest reading should not be entered anywhere.
Datatype
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
Beschrijving
Predicted normal should only be filled in for FEV1.
Datatype
float
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
Beschrijving
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.
Datatype
float
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0439165
Beschrijving
In this study, FEV1/FVC ratio should not be entered.
Datatype
float
Alias
- UMLS CUI [1,1]
- C0429745
- UMLS CUI [1,2]
- C0456603
Beschrijving
According to form: If NO, EXCLUDE subject from the study. In this study, this question should not bei answered.
Datatype
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])