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NCT00718640 · BASELINE

Baseline characteristics

An Efficacy and Safety Study of Bortezomib in Participants Previously Treated for Multiple Myeloma With Limited Kidney Function · Source last updated 2013-10-29

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
      10
    units
    Participants
groups
  1. description
    Bortezomib 1.3 milligram (mg) per meter\^2 (m\^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
    id
    BG000
    title
    Bortezomib and Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      < 65
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Between 65-69
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Between 70-74
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      >=75
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      10
    units
    Participants
groups
  1. description
    Bortezomib 1.3 milligram (mg) per meter\^2 (m\^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
    id
    BG000
    title
    Bortezomib and Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      < 65
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Between 65-69
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Between 70-74
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      >=75
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice