ID
39920
Beschrijving
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
Trefwoorden
Versies (3)
- 19-02-20 19-02-20 -
- 04-03-20 04-03-20 -
- 27-09-21 27-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 maart 2020
DOI
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Licentie
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
Beschrijving
Dosing date and time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Beschrijving
Sputum induction
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0857127
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C0040223
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0040223
Beschrijving
Sputum sample quality
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0332306
Beschrijving
Sputum sample quality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0332306
Beschrijving
Sputum colour
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0009393
Beschrijving
Sputum sample preparation and hemacytometry
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C1521827
- UMLS CUI-3
- C4054792
Beschrijving
Resuspension volume
Datatype
float
Maateenheden
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C1382107
Beschrijving
Weight of selected sputum
Datatype
float
Maateenheden
- g
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Beschrijving
Total cell count
Datatype
float
Maateenheden
- 10*4 Cells/mL
Alias
- UMLS CUI [1]
- C4272036
Beschrijving
If no, do not send sample.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0443348
Beschrijving
Sample collection summary
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0242482
Beschrijving
Sputum slide results entry
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0444330
- UMLS CUI-3
- C1254595
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C1516048
- UMLS CUI [1,2]
- C0040223
Beschrijving
Reader Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1707957
- UMLS CUI [1,2]
- C0237753
Beschrijving
Sputum Result Slide Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0444330
- UMLS CUI [1,4]
- C0237753
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0449475
- UMLS CUI [1,2]
- C1274040
Beschrijving
Result, absolute count
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0750480
Beschrijving
Result, percent of Total non squamous cells
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0439165
- UMLS CUI [1,3]
- C0439810
- UMLS CUI [1,4]
- C1545484
Beschrijving
Rejected slide
Datatype
text
Alias
- UMLS CUI [1,1]
- C0444330
- 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)
C0444330 (UMLS CUI [1,2])
C0444330 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0444330 (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])