0 Evaluaciones
ID

22765

Descripción

Study part: Run-In Screen Failure.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Palabras clave

Versiones (1)
  1. 11/6/17 11/6/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de junio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Run-In Screen Failure Mepolizumab HES NCT00086658

    Inglés

    Run-In Screen Failure

    1 formularios  
    1. StudyEvent: ODM
      1. Run-In Screen Failure
    SCREEN FAILURE / RUN-IN FAILURE
    Descripción

    SCREEN FAILURE / RUN-IN FAILURE

    Alias
    UMLS CUI-1
    C1710476 (Trial Screen Failure)
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Was this subject a screen failure / run-in failure?
    Descripción

    Screen Failure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1710476 (Trial Screen Failure)
    If Yes, screen failure / run-in failure date
    Descripción

    date Screen Failure

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C1710476 (Trial Screen Failure)
    Primary reason Adverse event
    Descripción

    Record details on Non-Serious Adverse Events or Serious Adverse Event page(s) as appropriate.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1549995 (Primary Reason)
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Primary reason Lost to follow-up
    Descripción

    primary reason Lost to follow-up

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1549995 (Primary Reason)
    UMLS CUI [1,2]
    C1302313 (Lost to Follow-Up)
    SNOMED
    399307001
    Primary reason Protocol violation
    Descripción

    primary reason Protocol violation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1549995 (Primary Reason)
    UMLS CUI [1,2]
    C1709750 (Protocol Violation)
    Primary reason Did not fulfil eligibility criteria
    Descripción

    primary reason eligibility criteria

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1549995 (Primary Reason)
    UMLS CUI [1,2]
    C1516637 (Clinical Trial Eligibility Criteria)
    Other, specify
    Descripción

    Other

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Volver a la parte superior de la página

    Similar models

    Run-In Screen Failure

    1 formularios
    1. StudyEvent: ODM
      1. Run-In Screen Failure
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    SCREEN FAILURE / RUN-IN FAILURE
    C1710476 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Screen Failure
    Item
    Was this subject a screen failure / run-in failure?
    boolean
    C1710476 (UMLS CUI [1])
    date Screen Failure
    Item
    If Yes, screen failure / run-in failure date
    date
    C0011008 (UMLS CUI [1,1])
    C1710476 (UMLS CUI [1,2])
    primary reason Adverse event
    Item
    Primary reason Adverse event
    boolean
    C1549995 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    primary reason Lost to follow-up
    Item
    Primary reason Lost to follow-up
    boolean
    C1549995 (UMLS CUI [1,1])
    C1302313 (UMLS CUI [1,2])
    primary reason Protocol violation
    Item
    Primary reason Protocol violation
    boolean
    C1549995 (UMLS CUI [1,1])
    C1709750 (UMLS CUI [1,2])
    primary reason eligibility criteria
    Item
    Primary reason Did not fulfil eligibility criteria
    boolean
    C1549995 (UMLS CUI [1,1])
    C1516637 (UMLS CUI [1,2])
    Other
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1])
    Volver a la parte superior de la página 

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