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NCT00104299 · BASELINE

Baseline characteristics

Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis · Source last updated 2017-04-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      99
    2. group Id
      BG001
      value
      98
    3. group Id
      BG002
      value
      197
    units
    Participants
groups
  1. description
    Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
    id
    BG000
    title
    Rituximab
  2. description
    Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
    id
    BG001
    title
    Control Group
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          136
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          55
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.8
          value
          54.0
        2. group Id
          BG001
          spread
          14.1
          value
          51.5
        3. group Id
          BG002
          spread
          15.5
          value
          52.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          97
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          100
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          181
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      Netherlands
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.8
          value
          8.1
        2. group Id
          BG001
          spread
          3.4
          value
          8.0
        3. group Id
          BG002
          spread
          3.1
          value
          8.0
    description
    The Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (WG) is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease. In this study, the primary end point was a BVAS/WG score of 0 and successful completion of the prednisone taper at 6 months.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BVAS/WG
    unit Of Measure
    score units
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.8
          value
          1.4
        2. group Id
          BG001
          spread
          1.4
          value
          1.0
        3. group Id
          BG002
          spread
          1.7
          value
          1.2
    description
    Vasculitis Damage Index. The VDI is a validated measure for damage assessment in vasculitis. The index comprises 64 items of damage (divided into 11 organ based systems) representative of damage incurred to patients with systemic vasculitis. Scores for this index range from 0 to 64, with higher scores indicating more severe damage.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    VDI
    unit Of Measure
    score units
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      99
    2. group Id
      BG001
      value
      98
    3. group Id
      BG002
      value
      197
    units
    Participants
groups
  1. description
    Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
    id
    BG000
    title
    Rituximab
  2. description
    Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
    id
    BG001
    title
    Control Group
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          136
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          55
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.8
          value
          54.0
        2. group Id
          BG001
          spread
          14.1
          value
          51.5
        3. group Id
          BG002
          spread
          15.5
          value
          52.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          97
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          100
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          181
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      Netherlands
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.8
          value
          8.1
        2. group Id
          BG001
          spread
          3.4
          value
          8.0
        3. group Id
          BG002
          spread
          3.1
          value
          8.0
    description
    The Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (WG) is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease. In this study, the primary end point was a BVAS/WG score of 0 and successful completion of the prednisone taper at 6 months.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BVAS/WG
    unit Of Measure
    score units
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.8
          value
          1.4
        2. group Id
          BG001
          spread
          1.4
          value
          1.0
        3. group Id
          BG002
          spread
          1.7
          value
          1.2
    description
    Vasculitis Damage Index. The VDI is a validated measure for damage assessment in vasculitis. The index comprises 64 items of damage (divided into 11 organ based systems) representative of damage incurred to patients with systemic vasculitis. Scores for this index range from 0 to 64, with higher scores indicating more severe damage.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    VDI
    unit Of Measure
    score units

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Preserved source evidence · Not medical advice