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ID

19898

Description

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.

Keywords

  1. 1/30/17 1/30/17 -
Uploaded on

January 30, 2017

DOI

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License

Creative Commons BY-NC 3.0

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    End of study CRFs Multiple Sklerosis Tysabri NCT00027300

    End of study CRFs Multiple Sklerosis Tysabri NCT00027300

    End of study
    Description

    End of study

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C0444930
    Did the subject complete the study?
    Description

    Completion of study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C1444661
    If "yes", mark the primary reason below
    Description

    Reason

    Data type

    text

    Alias
    UMLS CUI [1]
    C0392360
    Reason, why subject did not complete the study:
    Description

    Reason study not completed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0205257
    Description:
    Description

    Reason description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C0392360

    Similar models

    End of study CRFs Multiple Sklerosis Tysabri NCT00027300

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    End of study
    C0008976 (UMLS CUI-1)
    C0444930 (UMLS CUI-2)
    Completion of study
    Item
    Did the subject complete the study?
    boolean
    C0008976 (UMLS CUI [1,1])
    C1444661 (UMLS CUI [1,2])
    Reason
    Item
    If "yes", mark the primary reason below
    text
    C0392360 (UMLS CUI [1])
    Item
    Reason, why subject did not complete the study:
    integer
    C0392360 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0205257 (UMLS CUI [1,3])
    Code List
    Reason, why subject did not complete the study:
    CL Item
    Lost to follow-up (describe below) (1 )
    CL Item
    Adverse event(s) (complete Adverse Event form) (2 )
    CL Item
    Voluntary withdrawal for reasons other than Adverse Event (describe below) (3 )
    CL Item
    Subject was non-compliant (4 )
    CL Item
    Death (complete Record of Death form) (5 )
    CL Item
    Other (describe below) (6 )
    Reason description
    Item
    Description:
    text
    C0678257 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])

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