ID
34117
Beschreibung
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.
Stichworte
Versionen (1)
- 14.01.19 14.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
14. Januar 2019
DOI
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Lizenz
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
Beschreibung
Screening
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0220908
Beschreibung
Row number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024119
Beschreibung
Lung function test. Each test should be performed during screening procedure.
Datentyp
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
Beschreibung
Actual time of first reading
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0024119
Beschreibung
Reading 1
Datentyp
float
Alias
- UMLS CUI [1]
- C0242485
Beschreibung
Reading 2
Datentyp
float
Alias
- UMLS CUI [1]
- C0242485
Beschreibung
Reading 3
Datentyp
float
Alias
- UMLS CUI [1]
- C0242485
Beschreibung
According to form, highest reading should only be filled in for FEV1 and FVC. In this study, highest reading should not be entered anywhere.
Datentyp
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
Beschreibung
Predicted normal should only be filled in for FEV1.
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
Beschreibung
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.
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0439165
Beschreibung
In this study, FEV1/FVC ratio should not be entered.
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0429745
- UMLS CUI [1,2]
- C0456603
Beschreibung
According to form: If NO, EXCLUDE subject from the study. In this study, this question should not bei answered.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0439165
- UMLS CUI [2]
- C0429745
Ähnliche Modelle
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])