ID

15858

Descrição

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

Palavras-chave

  1. 16/06/2016 16/06/2016 -
Transferido a

16 de junho de 2016

DOI

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Licença

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
    Descrição

    Subject Identification

    Number of Facility
    Descrição

    Site number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0018704
    UMLS CUI [1,2]
    C0600091
    Subject number
    Descrição

    Subject number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials
    Descrição

    Subject Initials

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2986440
    Telepone Visit Details
    Descrição

    Telepone Visit Details

    Date of telephone call
    Descrição

    Date of telephone call

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0302186
    UMLS CUI [1,2]
    C0011008
    Person contacted
    Descrição

    if other please specify

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0337611
    Other person
    Descrição

    Other person

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0337611
    Since the subject was last contacted, has the subject experienced any new or continuing adverse events?
    Descrição

    if yes please specify in the CRF

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Since the subject was last contacted, has the subject received any concomitant medications?*
    Descrição

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2347852

    Similar models

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

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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