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ID

22459

Descrição

Study part: Investigational Product Discontinuation.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.

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Versões (1)
  1. 05/06/2017 05/06/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

5 de junho de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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    Investigational Product Discontinuation Mepolizumab HES NCT00086658

    Inglês

    Investigational Product Discontinuation

    1 Formulários  
    INVESTIGATIONAL PRODUCT DISCONTINUATION
    Descrição

    INVESTIGATIONAL PRODUCT DISCONTINUATION

    Alias
    UMLS CUI-1
    C0013230
    UMLS CUI-2
    C0457454
    Subject ID
    Descrição

    Subject ID

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Was the investigational product stopped permanently before the end of the scheduled treatment period?
    Descrição

    Investigational Product Discontinuation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0457454
    The primary reason the investigational product was stopped:
    Descrição

    Reason Investigational Product Discontinuation

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0457454
    If other, please specify
    Descrição

    Other

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0205394
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    Similar models

    Investigational Product Discontinuation

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    INVESTIGATIONAL PRODUCT DISCONTINUATION
    C0013230 (UMLS CUI-1)
    C0457454 (UMLS CUI-2)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Investigational Product Discontinuation
    Item
    Was the investigational product stopped permanently before the end of the scheduled treatment period?
    boolean
    C0013230 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    Item
    The primary reason the investigational product was stopped:
    text
    C0392360 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0457454 (UMLS CUI [1,3])
    Reason Investigational Product Discontinuation
    Code List
    The primary reason the investigational product was stopped:
    CL Item
    Lost to follow-up (Lost to follow-up)
    C1302313 (UMLS CUI-1)
    CL Item
    Protocol violation (Protocol violation)
    C1709750 (UMLS CUI-1)
    CL Item
    Subject decided to withdraw from the study (Subject decided to withdraw from the study)
    C2348571 (UMLS CUI-1)
    CL Item
    Lack of efficacy (Lack of efficacy)
    C0235828 (UMLS CUI-1)
    CL Item
    Sponsor terminated study (Sponsor terminated study)
    C1710224 (UMLS CUI-1)
    CL Item
    Disease progression (Disease progression)
    C0242656 (UMLS CUI-1)
    CL Item
    Other, specify (Other, specify)
    C0205394 (UMLS CUI-1)
    CL Item
    Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate))
    C0877248 (UMLS CUI-1)
    Other
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1])
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