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ID

39781

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 Asthma history form. It has to be filled in for screening.

collegamento

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

Keywords

  1. 19/02/20 19/02/20 -
Titolare del copyright

GlaxoSmithKline

Caricato su

19 febbraio 2020

DOI

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Licenza

Creative Commons BY-NC 3.0

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

    Asthma history

    1. StudyEvent: ODM
      1. Asthma history
    Administrative Data
    Descrizione

    Administrative Data

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

    Subject number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of visit
    Descrizione

    day month year

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Asthma history
    Descrizione

    Asthma history

    Alias
    UMLS CUI-1
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI-2
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    Has the subject been diagnosed with Asthma
    Descrizione

    Diagnosis of asthma

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815

    Similar models

    Asthma history

    1. StudyEvent: ODM
      1. Asthma history
    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])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Asthma history
    C0262926 (UMLS CUI-1)
    C0004096 (UMLS CUI-2)
    Item
    Has the subject been diagnosed with Asthma
    text
    C0004096 (UMLS CUI [1])
    Code List
    Has the subject been diagnosed with Asthma
    CL Item
    Yes (Y)
    CL Item
    No (N)

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