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ID

44851

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: End of Study

Keywords

Versions (2)
  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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    End of Study: Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    English

    End of Study: Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    1 forms  
    Subject Identification
    Description

    Subject Identification

    Number of Facility
    Description

    Site number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018704
    UMLS CUI [1,2]
    C0600091
    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
    End of Study Survey
    Description

    End of Study Survey

    Date of last dose
    Description

    Last Dose Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1762893
    End of Study Date
    Description

    End of Study Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670
    Did the subject complete the study?
    Description

    If no, please specify below

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348577
    Primary reason for not completing treatment (mark one)
    Description

    if other than MS, please describe below if Adverse Event, complete Adverse Events Form If Death, please complete Record of death form

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1709849
    Primary reason for not completing treatment, description
    Description

    Reason for non-completion, Description

    Data type

    text

    Alias
    UMLS CUI [1]
    C1709849
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    Similar models

    End of Study: Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    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
    End of Study Survey
    Last Dose Date
    Item
    Date of last dose
    date
    C1762893 (UMLS CUI [1])
    End of Study Date
    Item
    End of Study Date
    date
    C2983670 (UMLS CUI [1])
    Study completed
    Item
    Did the subject complete the study?
    boolean
    C2348577 (UMLS CUI [1])
    Item
    Primary reason for not completing treatment (mark one)
    integer
    C1709849 (UMLS CUI [1])
    Reason for non-completion
    Code List
    Primary reason for not completing treatment (mark one)
    CL Item
    MS Relapse (1)
    C0856120 (UMLS CUI-1)
    (Comment:en)
    CL Item
    MS Progression (2)
    C1536149 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Adverse Event (3)
    C0877248 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Lost to follow up (4)
    C1302313 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Consent withdrawn (5)
    C1707492 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Investigator decision (6)
    C1709536 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Subject non-compliance (7)
    C0376405 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Death (8)
    C0011065 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other (9)
    C3840932 (UMLS CUI-1)
    (Comment:en)
    Reason for non-completion, Description
    Item
    Primary reason for not completing treatment, description
    text
    C1709849 (UMLS CUI [1])
    Back to the top of the page 

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