ID
39783
Description
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Keywords
Versions (3)
- 2/19/20 2/19/20 -
- 3/4/20 3/4/20 -
- 9/27/21 9/27/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 19, 2020
DOI
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License
Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Sputum collection
- StudyEvent: ODM
Description
Dosing date and time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Description
Sputum induction
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0857127
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C0011008
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C0040223
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0011008
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0040223
Description
Sputum sample quality
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0332306
Description
Sputum sample quality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0332306
Description
Sputum colour
Data type
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0009393
Description
Sputum sample preparation and hemacytometry
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C1521827
- UMLS CUI-3
- C4054792
Description
Resuspension volume
Data type
float
Measurement units
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C1382107
Description
Weight of selected sputum
Data type
float
Measurement units
- g
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Description
Total cell count
Data type
float
Measurement units
- 10*4 Cells/mL
Alias
- UMLS CUI [1]
- C4272036
Description
If no, do not send sample.
Data type
text
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0443348
Description
Sample collection summary
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0242482
Description
Sputum slide results entry
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0444330
- UMLS CUI-3
- C1254595
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C1516048
- UMLS CUI [1,2]
- C0040223
Description
Reader Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1707957
- UMLS CUI [1,2]
- C0237753
Description
Sputum Result Slide Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C1254595
- UMLS CUI [1,3]
- C0444330
- UMLS CUI [1,4]
- C0237753
Description
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0449475
- UMLS CUI [1,2]
- C1274040
Description
Result, absolute count
Data type
integer
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0022885
Description
Result, percent of Total non squamous cells
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0439165
- UMLS CUI [1,3]
- C0439810
- UMLS CUI [1,4]
- C1545484
Description
Rejected slide
Data type
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])
C1254595 (UMLS CUI [1,2])
C0444330 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C1274040 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C1545484 (UMLS CUI [1,4])