0 Evaluaciones

ID

44854

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 22 (Week 216)

Palabras clave

  1. 18/6/16 18/6/16 -
  2. 17/2/22 17/2/22 - Martin Dugas
Titular de derechos de autor

Biogen

Subido en

17 de febrero de 2022

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0

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    Visit 22 (Week 216): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

    Visit 22 (Week 216): Vital Signs/Physical Examination 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
    Subject number
    Descripción

    Subject number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials
    Descripción

    Subject Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    Vital Signs
    Descripción

    Vital Signs

    Date of examination
    Descripción

    Date of examination

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826643
    Blood Pressure
    Descripción

    Blood Pressure

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0005823
    Pulse
    Descripción

    Pulse

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Temperature
    Descripción

    Temperature

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Physical examination
    Descripción

    Physical examination

    Body System
    Descripción

    Body System

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0460002
    Examination Status
    Descripción

    Examination Status

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0449438
    Abnormal examination findings
    Descripción

    physical examination findings

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0243095
    EDSS Evaluation
    Descripción

    EDSS Evaluation

    Date of Evaluation
    Descripción

    EDSS Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C0011008
    Functional System Scores
    Descripción

    Functional System Scores

    Visual
    Descripción

    Visual System EDSS

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0042789
    UMLS CUI [1,2]
    C0451246
    Brinstem
    Descripción

    Brainstem System EDSS

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C0006121
    Pyramidal
    Descripción

    Pyramidal System EDSS

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0228060
    UMLS CUI [1,2]
    C0451246
    Cerebellar
    Descripción

    Cerebellar System EDSS

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0007765
    UMLS CUI [1,2]
    C0451246
    Sensory
    Descripción

    Sensory System EDSS

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0682648
    UMLS CUI [1,2]
    C0451246
    Bowel or Bladder
    Descripción

    Bowel or Bladder System EDSS

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C2707247
    Cerebral
    Descripción

    Cerebral System EDSS

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0006104
    UMLS CUI [1,2]
    C0451246
    Additional and Results
    Descripción

    Additional and Results

    Actual Distance Walked
    Descripción

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

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0429886
    Actual Distance Walked
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0429886
    EDSS Score
    Descripción

    EDSS score

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0451246
    Name of Neurologist
    Descripción

    Name of Neurologist

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0237426
    UMLS CUI [1,2]
    C0027365
    Visual Function Test
    Descripción

    Visual Function Test

    Date of Evaluation
    Descripción

    Visual Function test, date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0234621
    UMLS CUI [1,2]
    C0392366
    UMLS CUI [1,3]
    C0011008
    Contrast Sensitivity Evaluation Binocular
    Descripción

    Contrast Sensitivity Evaluation Binocular

    100% Chart, Total # Correct
    Descripción

    Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0009928
    UMLS CUI [1,2]
    C0042794
    2,5% Chart, Total # Correct
    Descripción

    Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0009928
    UMLS CUI [1,2]
    C0042794
    1,25% Chart, Total # Correct
    Descripción

    Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0009928
    UMLS CUI [1,2]
    C0042794
    Snellen visual acuity equivalent
    Descripción

    Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0009928
    UMLS CUI [1,2]
    C0042794
    Study Drug Accountability
    Descripción

    Study Drug Accountability

    date of first dose
    Descripción

    first dose date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C3173309
    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
    UMLS CUI [1,2]
    C0178602
    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

    Similar models

    Visit 22 (Week 216): Vital Signs/Physical Examination 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])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Physical examination
    Item
    Body System
    integer
    C0460002 (UMLS CUI [1])
    Code List
    Body System
    CL Item
    Skin (1)
    C1123023 (UMLS CUI-1)
    (Comment:en)
    CL Item
    HEENT  (2)
    C1512338 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Lymph nodes (3)
    C0024204 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Neck and Thyroid  (4)
    C0460004 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Breasts (5)
    C0006141 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Chest/Lungs (6)
    C0817096 (UMLS CUI-1)
    C0024109 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Heart  (7)
    C0018787 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Vascular (8)
    C1801960 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Abdomen (9)
    C0000726 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Rectal  (10)
    C0205052 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Neurological  (11)
    CL Item
    Extremities/Joints (12)
    Item
    Examination Status
    integer
    C0031809 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Code List
    Examination Status
    CL Item
    Not done (1)
    CL Item
    Normal (2)
    CL Item
    Abnormal (please specify) (3)
    physical examination findings
    Item
    Abnormal examination findings
    text
    C0031809 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    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])
    Item Group
    Visual Function Test
    Visual Function test, date
    Item
    Date of Evaluation
    date
    C0234621 (UMLS CUI [1,1])
    C0392366 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Contrast Sensitivity Evaluation Binocular
    Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
    Item
    100% Chart, Total # Correct
    float
    C0009928 (UMLS CUI [1,1])
    C0042794 (UMLS CUI [1,2])
    Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
    Item
    2,5% Chart, Total # Correct
    float
    C0009928 (UMLS CUI [1,1])
    C0042794 (UMLS CUI [1,2])
    Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
    Item
    1,25% Chart, Total # Correct
    float
    C0009928 (UMLS CUI [1,1])
    C0042794 (UMLS CUI [1,2])
    Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
    Item
    Snellen visual acuity equivalent
    text
    C0009928 (UMLS CUI [1,1])
    C0042794 (UMLS CUI [1,2])
    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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