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ID

39898

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

Versies (2)
  1. 25-02-20 25-02-20 -
  2. 02-03-20 02-03-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

2 maart 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

    Engels

    Cystic fibrosis exacerbations

    1 Formulieren  
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject number
    Beschrijving

    Subject number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Cystic fibrosis exacerbations
    Beschrijving

    Cystic fibrosis exacerbations

    Alias
    UMLS CUI-1
    C0010674 (Cystic Fibrosis)
    SNOMED
    190905008
    UMLS CUI-2
    C4086268 (Exacerbation)
    Date of Exacerbation Onset
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0574845 (Date of onset)
    SNOMED
    298059007
    LOINC
    MTHU048807
    UMLS CUI [1,2]
    C0010674 (Cystic Fibrosis)
    SNOMED
    190905008
    UMLS CUI [1,3]
    C4086268 (Exacerbation)
    Time of Exacerbation Onset
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0449244 (Time of onset)
    SNOMED
    263501003
    UMLS CUI [1,2]
    C0010674 (Cystic Fibrosis)
    SNOMED
    190905008
    UMLS CUI [1,3]
    C4086268 (Exacerbation)
    Date of Exacerbation Resolution
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C2699488 (Resolution)
    UMLS CUI [1,3]
    C0010674 (Cystic Fibrosis)
    SNOMED
    190905008
    UMLS CUI [1,4]
    C4086268 (Exacerbation)
    Time of Exacerbation Resolution
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C2699488 (Resolution)
    UMLS CUI [1,3]
    C0010674 (Cystic Fibrosis)
    SNOMED
    190905008
    UMLS CUI [1,4]
    C4086268 (Exacerbation)
    Were antibiotics prescribed for the exacerbation?
    Beschrijving

    Antibiotics prescription for exacerbation of CF

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0003232 (Antibiotics)
    SNOMED
    255631004
    LOINC
    LP31426-7
    UMLS CUI [1,2]
    C0033080 (Prescription procedure)
    SNOMED
    260885003
    UMLS CUI [1,3]
    C0010674 (Cystic Fibrosis)
    SNOMED
    190905008
    UMLS CUI [1,4]
    C4086268 (Exacerbation)
    Was the subject hospitalised due to exacerbation?
    Beschrijving

    Hospitalisation of subject due to exacerbation of CF

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [1,2]
    C0010674 (Cystic Fibrosis)
    SNOMED
    190905008
    UMLS CUI [1,3]
    C4086268 (Exacerbation)
    Was the subject withdrawn due to exacerbation?
    Beschrijving

    Withdrawal of subject due to exacerbation of CF

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0010674 (Cystic Fibrosis)
    SNOMED
    190905008
    UMLS CUI [1,3]
    C4086268 (Exacerbation)
    Terug naar het begin van de pagina

    Similar models

    Cystic fibrosis exacerbations

    1 Formulieren
    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 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])
    Antibiotics prescription for exacerbation
    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])
    Antibiotics prescription for exacerbation
    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])
    Antibiotics prescription for exacerbation
    Code List
    Was the subject withdrawn due to exacerbation?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Terug naar het begin van de pagina 

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