ID
34117
Descripción
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.
Palabras clave
Versiones (1)
- 14/1/19 14/1/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
14 de enero de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)
Lung function tests: Screening
- StudyEvent: ODM
Descripción
Screening
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0220908
Descripción
Row number
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2348184
Descripción
Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024119
Descripción
Lung function test. Each test should be performed during screening procedure.
Tipo de datos
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
Descripción
Actual time of first reading
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0024119
Descripción
Reading 1
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0242485
Descripción
Reading 2
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0242485
Descripción
Reading 3
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0242485
Descripción
According to form, highest reading should only be filled in for FEV1 and FVC. In this study, highest reading should not be entered anywhere.
Tipo de datos
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
Descripción
Predicted normal should only be filled in for FEV1.
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
Descripción
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.
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0439165
Descripción
In this study, FEV1/FVC ratio should not be entered.
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0429745
- UMLS CUI [1,2]
- C0456603
Descripción
According to form: If NO, EXCLUDE subject from the study. In this study, this question should not bei answered.
Tipo de datos
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])