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NCT01200758 · BASELINE

Baseline characteristics

A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma · Source last updated 2018-11-27

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
      205
    2. group Id
      BG001
      value
      205
    3. group Id
      BG002
      value
      410
    units
    Participants
groups
  1. description
    Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
    id
    BG000
    title
    Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
  2. description
    First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
    id
    BG001
    title
    Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          28
          spread
          12.69
          upper Limit
          86
          value
          56.9
        2. group Id
          BG001
          lower Limit
          28
          spread
          12.66
          upper Limit
          85
          value
          56.1
        3. group Id
          BG002
          lower Limit
          28
          spread
          12.67
          upper Limit
          86
          value
          56.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          219
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          191
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Population included all participants who were randomized into study irrespective whether they received study drug or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      205
    2. group Id
      BG001
      value
      205
    3. group Id
      BG002
      value
      410
    units
    Participants
groups
  1. description
    Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
    id
    BG000
    title
    Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
  2. description
    First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
    id
    BG001
    title
    Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          28
          spread
          12.69
          upper Limit
          86
          value
          56.9
        2. group Id
          BG001
          lower Limit
          28
          spread
          12.66
          upper Limit
          85
          value
          56.1
        3. group Id
          BG002
          lower Limit
          28
          spread
          12.67
          upper Limit
          86
          value
          56.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          219
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          191
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Population included all participants who were randomized into study irrespective whether they received study drug or not.

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Preserved source evidence · Not medical advice