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ID

19909

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. Documentation process: This form is to be obtained in week 0.

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  1. 1/30/17 1/30/17 -
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January 30, 2017

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Creative Commons BY-NC 3.0
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    Baseline Signs and Symptoms CRFs Multiple Sclerosis Tysabri NCT00027300

    English

    Baseline Signs and Symptoms CRFs Multiple Sclerosis Tysabri NCT00027300

    1 forms  
    Baseline Signs and Symptoms
    Description

    Baseline Signs and Symptoms

    Alias
    UMLS CUI-1
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    Line No.
    Description

    Line Number

    Data type

    integer

    Sign or Symptom
    Description

    Sign or Symptom

    Data type

    text

    Alias
    UMLS CUI [1]
    C3540840 (Sign or Symptom)
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Not Resolved
    Description

    Not Resolved

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C1709863 (Recovered or Resolved)
    Severity
    Description

    Severity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0439793 (Severities)
    SNOMED
    272141005
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    Similar models

    Baseline Signs and Symptoms CRFs Multiple Sclerosis Tysabri NCT00027300

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Baseline Signs and Symptoms
    C0037088 (UMLS CUI-1)
    Item
    Line No.
    integer
    Line Number
    Code List
    Line No.
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Sign or Symptom
    Item
    Sign or Symptom
    text
    C3540840 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Item
    Not Resolved
    integer
    C0877248 (UMLS CUI [1,1])
    C1709863 (UMLS CUI [1,2])
    Not Resolved
    Code List
    Not Resolved
    CL Item
    Not Resolved (1)
    Item
    Severity
    integer
    C0439793 (UMLS CUI [1])
    Severity
    Code List
    Severity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
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