ID

44863

Description

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: Visit 11 (Week 84)

Keywords

  1. 6/14/16 6/14/16 -
  2. 2/17/22 2/17/22 - Martin Dugas
Copyright Holder

Biogen

Uploaded on

February 17, 2022

DOI

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License

Creative Commons BY-NC 4.0

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    Visit 11 (Week 84): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    Visit 11 (Week 84): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    Subject Identification
    Description

    Subject Identification

    Number of Facility
    Description

    Site number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826711
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials
    Description

    Subject Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Vital Signs
    Description

    Vital Signs

    Date of examination
    Description

    Date of examination

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643
    Blood Pressure
    Description

    Blood Pressure

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005823
    Pulse
    Description

    Pulse

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Study Drug Accountability
    Description

    Study Drug Accountability

    date of first dose
    Description

    first dose date

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    Number of capsules not taken since previous visit to this visit
    Description

    number of capsules not taken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1705492
    UMLS CUI [1,2]
    C0178602
    Was there a protocol-defined dose reduction/interruption since the previous visit?
    Description

    If no, please specify on the appropriate adverse events form

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1707814

    Similar models

    Visit 11 (Week 84): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Subject Identification
    Site number
    Item
    Number of Facility
    integer
    C2826711 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Subject Initials
    Item
    Subject Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Vital Signs
    Date of examination
    Item
    Date of examination
    date
    C2826643 (UMLS CUI [1])
    Blood Pressure
    Item
    Blood Pressure
    text
    C0005823 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Study Drug Accountability
    first dose date
    Item
    date of first dose
    date
    C3173309 (UMLS CUI [1])
    number of capsules not taken
    Item
    Number of capsules not taken since previous visit to this visit
    integer
    C1705492 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    protocol-defined dose reduction/interruption
    Item
    Was there a protocol-defined dose reduction/interruption since the previous visit?
    boolean
    C1707814 (UMLS CUI [1])

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