ID
44681
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Nyckelord
Versioner (3)
- 2020-02-19 2020-02-19 -
- 2020-03-04 2020-03-04 -
- 2021-09-27 2021-09-27 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 september 2021
DOI
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Licens
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
Beskrivning
Dosing date and time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Beskrivning
Sputum induction
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0857127
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C0040223
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0040223
Beskrivning
Sputum sample quality
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0332306
Beskrivning
Sputum sample quality
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0332306
Beskrivning
Sputum colour
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0009393
Beskrivning
Sputum sample preparation and hemacytometry
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C1521827
- UMLS CUI-3
- C4054792
Beskrivning
Resuspension volume
Datatyp
float
Måttenheter
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C1382107
Beskrivning
Weight of selected sputum
Datatyp
float
Måttenheter
- g
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Beskrivning
Total cell count
Datatyp
float
Måttenheter
- 10*4 Cells/mL
Alias
- UMLS CUI [1]
- C4272036
Beskrivning
If no, do not send sample.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0443348
Beskrivning
Sample collection summary
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0242482
Beskrivning
Sputum slide results entry
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C1705201
- UMLS CUI-3
- C1254595
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1516048
- UMLS CUI [1,2]
- C0040223
Beskrivning
Reader Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1707957
- UMLS CUI [1,2]
- C0237753
Beskrivning
Sputum Result Slide Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1705201
- UMLS CUI [1,4]
- C0237753
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0449475
- UMLS CUI [1,2]
- C1274040
Beskrivning
Result, absolute count
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0750480
Beskrivning
Result, percent of Total non squamous cells
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0439165
- UMLS CUI [1,3]
- C0439810
- UMLS CUI [1,4]
- C1545484
Beskrivning
Rejected slide
Datatyp
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])