ID

39869

Beschrijving

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

Trefwoorden

  1. 25-02-20 25-02-20 -
  2. 02-03-20 02-03-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 februari 2020

DOI

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Licentie

Creative Commons BY-NC 4.0

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

Cystic fibrosis exacerbations

Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Cystic fibrosis exacerbations
Beschrijving

Cystic fibrosis exacerbations

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

day month year

Datatype

date

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

00:00-23:59

Datatype

time

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

day month year

Datatype

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
Beschrijving

00:00-23:59

Datatype

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?
Beschrijving

Antibiotics prescription for exacerbation

Datatype

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?
Beschrijving

Hospitalisation of subject due to exacerbation

Datatype

text

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Was the subject withdrawn due to exacerbation?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

Withdrawal of subject due to exacerbation

Datatype

text

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

Similar models

Cystic fibrosis exacerbations

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)

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