ID
44681
Descripción
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Sputum collection form. It has to be filled in for V2b, V5 and if requiered for logs/ repeats. This document can be filled in as often as necessary for logs/ repeats.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Palabras clave
Versiones (3)
- 19/2/20 19/2/20 -
- 4/3/20 4/3/20 -
- 27/9/21 27/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
27 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Sputum collection
- StudyEvent: ODM
Descripción
Dosing date and time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Descripción
Sputum induction
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0857127
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C0011008
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C0040223
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0011008
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0040223
Descripción
Sputum sample quality
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0332306
Descripción
Sputum sample quality
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0332306
Descripción
Sputum colour
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0009393
Descripción
Sputum sample preparation and hemacytometry
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C1521827
- UMLS CUI-3
- C4054792
Descripción
Resuspension volume
Tipo de datos
float
Unidades de medida
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C1382107
Descripción
Weight of selected sputum
Tipo de datos
float
Unidades de medida
- g
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Descripción
Total cell count
Tipo de datos
float
Unidades de medida
- 10*4 Cells/mL
Alias
- UMLS CUI [1]
- C4272036
Descripción
If no, do not send sample.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0443348
Descripción
Sample collection summary
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0242482
Descripción
Sputum slide results entry
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C1705201
- UMLS CUI-3
- C1254595
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985720
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1516048
- UMLS CUI [1,2]
- C0040223
Descripción
Reader Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1707957
- UMLS CUI [1,2]
- C0237753
Descripción
Sputum Result Slide Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1705201
- UMLS CUI [1,4]
- C0237753
Descripción
Fill in the result and the percent of total non squamous cells for each cell type (except for Squamous cells, Total non squamous cells, Total Cells counted) in the following items.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0449475
- UMLS CUI [1,2]
- C1274040
Descripción
Result, absolute count
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0750480
Descripción
Result, percent of Total non squamous cells
Tipo de datos
float
Unidades de medida
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0439165
- UMLS CUI [1,3]
- C0439810
- UMLS CUI [1,4]
- C1545484
Descripción
Rejected slide
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1705201
- UMLS CUI [1,2]
- C1548437
Similar models
Sputum collection
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1709694 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1709694 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0332306 (UMLS CUI [1,2])
C1521827 (UMLS CUI-2)
C4054792 (UMLS CUI-3)
C1382107 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,2])
C0443348 (UMLS CUI [1,2])
C0242482 (UMLS CUI-2)
C1705201 (UMLS CUI [1,2])
C1705201 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C1705201 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C1274040 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C1545484 (UMLS CUI [1,4])