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ID

15725

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: Visit 3 (Week 12)

Palavras-chave

  1. 09/06/2016 09/06/2016 -
Transferido a

9 de junho de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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    Visit 3 (Week 12): EDSS evaluation BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    Visit 3 (Week 12): EDSS evaluation 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 (Health care facility)
    SNOMED
    257622000
    LOINC
    LA30302-6
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject number
    Descrição

    Subject number

    Tipo de dados

    integer

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

    Subject Initials

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    EDSS Evaluation
    Descrição

    EDSS Evaluation

    Date of Evaluation
    Descrição

    EDSS Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Functional System Scores
    Descrição

    Functional System Scores

    Visual
    Descrição

    Visual System EDSS

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0042789 (Vision)
    SNOMED
    281004000
    LOINC
    LP30560-4
    UMLS CUI [1,2]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    Brinstem
    Descrição

    Brainstem System EDSS

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C0006121 (Brain Stem)
    SNOMED
    15926001
    Pyramidal
    Descrição

    Pyramidal System EDSS

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0228060 (Pyramidal system)
    SNOMED
    24314005
    UMLS CUI [1,2]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    Cerebellar
    Descrição

    Cerebellar System EDSS

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0007765 (Cerebellum)
    SNOMED
    113305005
    LOINC
    LP7125-0
    UMLS CUI [1,2]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    Sensory
    Descrição

    Sensory System EDSS

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0682648 (sensory nervous system)
    UMLS CUI [1,2]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    Bowel or Bladder
    Descrição

    Bowel or Bladder System EDSS

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C2707247 (Bladder and bowel)
    LOINC
    LP89773-3
    Cerebral
    Descrição

    Cerebral System EDSS

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0006104 (Brain)
    SNOMED
    12738006
    LOINC
    LP7084-9
    UMLS CUI [1,2]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    Additional and Results
    Descrição

    Additional and Results

    Actual Distance Walked
    Descrição

    type the number that indicates the furthest distance the subject is able to walk without aid or rest

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0429886 (Walking distance)
    SNOMED
    165263003
    LOINC
    LP35942-9
    Actual Distance Walked
    Descrição

    type the number that indicates the furthest distance the subject is able to walk without aid or rest

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0429886 (Walking distance)
    SNOMED
    165263003
    LOINC
    LP35942-9
    EDSS Score
    Descrição

    EDSS score

    Tipo de dados

    float

    Alias
    UMLS CUI [1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    Name of Neurologist
    Descrição

    Name of Neurologist

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0237426 (Neurologists)
    SNOMED
    56397003
    UMLS CUI [1,2]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6

    Similar models

    Visit 3 (Week 12): EDSS evaluation 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])
    Item Group
    EDSS Evaluation
    EDSS Date
    Item
    Date of Evaluation
    date
    C0451246 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Functional System Scores
    Visual System EDSS
    Item
    Visual
    text
    C0042789 (UMLS CUI [1,1])
    C0451246 (UMLS CUI [1,2])
    Brainstem System EDSS
    Item
    Brinstem
    text
    C0451246 (UMLS CUI [1,1])
    C0006121 (UMLS CUI [1,2])
    Pyramidal System EDSS
    Item
    Pyramidal
    text
    C0228060 (UMLS CUI [1,1])
    C0451246 (UMLS CUI [1,2])
    Cerebellar System EDSS
    Item
    Cerebellar
    text
    C0007765 (UMLS CUI [1,1])
    C0451246 (UMLS CUI [1,2])
    Sensory System EDSS
    Item
    Sensory
    text
    C0682648 (UMLS CUI [1,1])
    C0451246 (UMLS CUI [1,2])
    Bowel or Bladder System EDSS
    Item
    Bowel or Bladder
    text
    C0451246 (UMLS CUI [1,1])
    C2707247 (UMLS CUI [1,2])
    Cerebral System EDSS
    Item
    Cerebral
    text
    C0006104 (UMLS CUI [1,1])
    C0451246 (UMLS CUI [1,2])
    Item Group
    Additional and Results
    Item
    Actual Distance Walked
    text
    C0429886 (UMLS CUI [1])
    Code List
    Actual Distance Walked
    CL Item
    <100 metres (<100 metres)
    CL Item
    >100 metres and <200 metres (>100 metres and <200 metres)
    CL Item
    >200 metres and <300 metres (>200 metres and <300 metres)
    CL Item
    >300 metres and <500 metres (>300 metres and <500 metres)
    CL Item
    >500 metres (>500 metres)
    Item
    Actual Distance Walked
    integer
    C0429886 (UMLS CUI [1])
    Code List
    Actual Distance Walked
    CL Item
    <100 metres (1)
    CL Item
    >100 metres and <200 metres (2)
    CL Item
    >200 metres and <300 metres (3)
    CL Item
    >300 metres and <500 metres (4)
    CL Item
    >500 metres (5)
    EDSS score
    Item
    EDSS Score
    float
    C0451246 (UMLS CUI [1])
    Name of Neurologist
    Item
    Name of Neurologist
    text
    C0237426 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])

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