ID
39898
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 Cystic fibrosis exacerbations form. It has to be filled in if the subject has a cystic fibrosis exacerbation during the study.
Länk
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Nyckelord
Versioner (2)
- 2020-02-25 2020-02-25 -
- 2020-03-02 2020-03-02 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
2 mars 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Cystic fibrosis exacerbations
- StudyEvent: ODM
Beskrivning
Cystic fibrosis exacerbations
Alias
- UMLS CUI-1
- C0010674
- UMLS CUI-2
- C4086268
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Beskrivning
Antibiotics prescription for exacerbation of CF
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003232
- UMLS CUI [1,2]
- C0033080
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Beskrivning
Hospitalisation of subject due to exacerbation of CF
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Beskrivning
Withdrawal of subject due to exacerbation of CF
Datatyp
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])
Inga kommentarer