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ID

15858

Beskrivning

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Telephone Visit

Nyckelord

  1. 2016-06-16 2016-06-16 -
Uppladdad den

16 juni 2016

DOI

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Creative Commons BY-NC 3.0

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    Telephone Visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    Telephone Visit Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    Subject Identification
    Beskrivning

    Subject Identification

    Number of Facility
    Beskrivning

    Site number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0018704 (Health care facility)
    SNOMED
    257622000
    LOINC
    LA30302-6
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject number
    Beskrivning

    Subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Subject Initials
    Beskrivning

    Subject Initials

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Telepone Visit Details
    Beskrivning

    Telepone Visit Details

    Date of telephone call
    Beskrivning

    Date of telephone call

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0302186 (Telephone Call)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Person contacted
    Beskrivning

    if other please specify

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0337611 (contact person)
    SNOMED
    70862002
    Other person
    Beskrivning

    Other person

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0337611 (contact person)
    SNOMED
    70862002
    Since the subject was last contacted, has the subject experienced any new or continuing adverse events?
    Beskrivning

    if yes please specify in the CRF

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Since the subject was last contacted, has the subject received any concomitant medications?*
    Beskrivning

    *Includes IV Steroid therapy and alternate MS therapy. If yes please record concomitant medications in the CRF.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)

    Similar models

    Telephone Visit Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Subject Identification
    Site number
    Item
    Number of Facility
    integer
    C0018704 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Subject Initials
    Item
    Subject Initials
    text
    C2986440 (UMLS CUI [1])
    Date of telephone call
    Item
    Date of telephone call
    date
    C0302186 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Person contacted
    integer
    C0337611 (UMLS CUI [1])
    Code List
    Person contacted
    CL Item
    subject (1)
    CL Item
    other  (2)
    CL Item
    unable to make contact (3)
    Other person
    Item
    Other person
    text
    C0337611 (UMLS CUI [1])
    adverse events
    Item
    Since the subject was last contacted, has the subject experienced any new or continuing adverse events?
    boolean
    C0877248 (UMLS CUI [1])
    concomitant medication
    Item
    Since the subject was last contacted, has the subject received any concomitant medications?*
    boolean
    C2347852 (UMLS CUI [1])

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