0 Evaluaciones

ID

44863

Descripción

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)

Palabras clave

  1. 14/6/16 14/6/16 -
  2. 17/2/22 17/2/22 - Martin Dugas
Titular de derechos de autor

Biogen

Subido en

17 de febrero de 2022

DOI

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Licencia

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
    Descripción

    Subject Identification

    Number of Facility
    Descripción

    Site number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2826711 (Study Site Number)
    Subject number
    Descripción

    Subject number

    Tipo de datos

    integer

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

    Subject Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Vital Signs
    Descripción

    Vital Signs

    Date of examination
    Descripción

    Date of examination

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826643 (Physical Examination Date)
    Blood Pressure
    Descripción

    Blood Pressure

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    Pulse
    Descripción

    Pulse

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    bpm
    Temperature
    Descripción

    Temperature

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
    Study Drug Accountability
    Descripción

    Study Drug Accountability

    date of first dose
    Descripción

    first dose date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    Number of capsules not taken since previous visit to this visit
    Descripción

    number of capsules not taken

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1705492 (Missing)
    LOINC
    LA14698-7
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Was there a protocol-defined dose reduction/interruption since the previous visit?
    Descripción

    If no, please specify on the appropriate adverse events form

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1707814 (Dose Reduced)

    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
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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