ID
39759
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 electronically transferred lab data form. It has to be filled in for screening,V2a, V3, V5, follow-up and if requiered for logs/ repeats.
Lien
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Mots-clés
Versions (2)
- 17/02/2020 17/02/2020 -
- 04/03/2020 04/03/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
17 février 2020
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Laboratory data
- StudyEvent: ODM
Description
Haematology
Alias
- UMLS CUI-1
- C0018941
Description
day month year. If a blood sample has not taken/ not done, please tick the item "no blood sample taken".
Type de données
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Description
No blood sample taken
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1272696
Description
Clinical chemistry
Alias
- UMLS CUI-1
- C0008000
Description
Same as haematology sample
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0445247
- UMLS CUI [1,4]
- C0018941
Description
day month year. If a blood sample has not taken/ not done, please tick the item "no blood sample taken".
Type de données
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Description
No blood sample taken
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1272696
Description
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
day month year. If a sample has not taken/ not done, please tick the item "no sample taken".
Type de données
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Description
No sample taken
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1272696
Similar models
Laboratory data
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])