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ID

22457

Description

Study part: Study conclusion.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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Versions (1)
  1. 05/06/17 05/06/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

5 giugno 2017

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Creative Commons BY-NC 3.0
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    Study conclusion Mepolizumab HES NCT00086658

    English

    Study conclusion

    1 forms  
    1. StudyEvent: ODM
      1. Study conclusion
    STUDY CONCLUSION
    Description

    STUDY CONCLUSION

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008972 (Clinical Research)
    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of subject completion or withdrawal
    Description

    Date of subject completion or withdrawal

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    Was the subject withdrawn from the study?
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    The primary reason for withdrawal:
    Description

    reason study conclusion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C1707478 (Conclusion)
    UMLS CUI [1,3]
    C0008972 (Clinical Research)
    If other, please specify
    Description

    Other

    Data type

    text

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

    Study conclusion

    1 forms
    1. StudyEvent: ODM
      1. Study conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    STUDY CONCLUSION
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    Was the subject withdrawn from the study?
    boolean
    C2348568 (UMLS CUI [1])
    Item
    The primary reason for withdrawal:
    text
    C0392360 (UMLS CUI [1,1])
    C1707478 (UMLS CUI [1,2])
    C0008972 (UMLS CUI [1,3])
    reason study conclusion
    Code List
    The primary reason for withdrawal:
    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)
    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)
    Other
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1])
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