ID
39898
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 Cystic fibrosis exacerbations form. It has to be filled in if the subject has a cystic fibrosis exacerbation during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Keywords
Versions (2)
- 2/25/20 2/25/20 -
- 3/2/20 3/2/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 2, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Cystic fibrosis exacerbations
- StudyEvent: ODM
Description
Cystic fibrosis exacerbations
Alias
- UMLS CUI-1
- C0010674
- UMLS CUI-2
- C4086268
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Description
Antibiotics prescription for exacerbation of CF
Data type
text
Alias
- UMLS CUI [1,1]
- C0003232
- UMLS CUI [1,2]
- C0033080
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Description
Hospitalisation of subject due to exacerbation of CF
Data type
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Description
Withdrawal of subject due to exacerbation of CF
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Similar models
Cystic fibrosis exacerbations
- StudyEvent: ODM
C4086268 (UMLS CUI-2)
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
C0033080 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])