ID

39869

Descrizione

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.

collegamento

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Keywords

  1. 25/02/20 25/02/20 -
  2. 02/03/20 02/03/20 -
Titolare del copyright

GlaxoSmithKline

Caricato su

25 febbraio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 4.0

Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

Cystic fibrosis exacerbations

Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descrizione

Subject number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Cystic fibrosis exacerbations
Descrizione

Cystic fibrosis exacerbations

Alias
UMLS CUI-1
C0010674
UMLS CUI-2
C4086268
Date of Exacerbation Onset
Descrizione

day month year

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268
Time of Exacerbation Onset
Descrizione

00:00-23:59

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268
Date of Exacerbation Resolution
Descrizione

day month year

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C0010674
UMLS CUI [1,4]
C4086268
Time of Exacerbation Resolution
Descrizione

00:00-23:59

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C0010674
UMLS CUI [1,4]
C4086268
Were antibiotics prescribed for the exacerbation?
Descrizione

Antibiotics prescription for exacerbation

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0033080
UMLS CUI [1,3]
C0010674
UMLS CUI [1,4]
C4086268
Was the subject hospitalised due to exacerbation?
Descrizione

Hospitalisation of subject due to exacerbation

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268
Was the subject withdrawn due to exacerbation?
Descrizione

Withdrawal of subject due to exacerbation

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268

Similar models

Cystic fibrosis exacerbations

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Cystic fibrosis exacerbations
C0010674 (UMLS CUI-1)
C4086268 (UMLS CUI-2)
Date of Exacerbation Onset
Item
Date of Exacerbation Onset
date
C0574845 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Time of Exacerbation Onset
Item
Time of Exacerbation Onset
time
C0449244 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Date of Exacerbation Resolution
Item
Date of Exacerbation Resolution
date
C0011008 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
Time of Exacerbation Resolution
Item
Time of Exacerbation Resolution
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
Item
Were antibiotics prescribed for the exacerbation?
text
C0003232 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
Code List
Were antibiotics prescribed for the exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the subject hospitalised due to exacerbation?
text
C0019993 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Code List
Was the subject hospitalised due to exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the subject withdrawn due to exacerbation?
text
C0422727 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Code List
Was the subject withdrawn due to exacerbation?
CL Item
Yes (Y)
CL Item
No (N)

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial