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ID

22459

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2017-06-05 2017-06-05 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 juni 2017

DOI

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

    Engelsk

    Investigational Product Discontinuation

    1 Formulär  
    INVESTIGATIONAL PRODUCT DISCONTINUATION
    Beskrivning

    INVESTIGATIONAL PRODUCT DISCONTINUATION

    Alias
    UMLS CUI-1
    C0013230 (Investigational New Drugs)
    UMLS CUI-2
    C0457454 (Discontinuation (procedure))
    Subject ID
    Beskrivning

    Subject ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Was the investigational product stopped permanently before the end of the scheduled treatment period?
    Beskrivning

    Investigational Product Discontinuation

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230 (Investigational New Drugs)
    UMLS CUI [1,2]
    C0457454 (Discontinuation (procedure))
    The primary reason the investigational product was stopped:
    Beskrivning

    Reason Investigational Product Discontinuation

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0013230 (Investigational New Drugs)
    UMLS CUI [1,3]
    C0457454 (Discontinuation (procedure))
    If other, please specify
    Beskrivning

    Other

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
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    Similar models

    Investigational Product Discontinuation

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

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