0 Evaluaciones

ID

39898

Descripción

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

Palabras clave

  1. 25/2/20 25/2/20 -
  2. 2/3/20 2/3/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

2 de marzo de 2020

DOI

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Licencia

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
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Descripción

    Subject number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Cystic fibrosis exacerbations
    Descripción

    Cystic fibrosis exacerbations

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

    day month year

    Tipo de datos

    date

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

    00:00-23:59

    Tipo de datos

    time

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

    day month year

    Tipo de datos

    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
    Descripción

    00:00-23:59

    Tipo de datos

    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?
    Descripción

    Antibiotics prescription for exacerbation of CF

    Tipo de datos

    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?
    Descripción

    Hospitalisation of subject due to exacerbation of CF

    Tipo de datos

    text

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    Was the subject withdrawn due to exacerbation?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

    Withdrawal of subject due to exacerbation of CF

    Tipo de datos

    text

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

    Similar models

    Cystic fibrosis exacerbations

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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 of CF 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 of CF 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 of CF 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 of CF 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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