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NCT00813150 · BASELINE

Baseline characteristics

Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma · Source last updated 2014-08-15

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
      43
    2. group Id
      BG001
      value
      47
    3. group Id
      BG002
      value
      90
    units
    Participants
groups
  1. description
    Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
    id
    BG000
    title
    Vd (Bortezomib + Dexamethasone)
  2. description
    Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
    id
    BG001
    title
    Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10
          value
          68
        2. group Id
          BG001
          spread
          7
          value
          71
        3. group Id
          BG002
          spread
          9
          value
          69
    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
          18
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          39
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          51
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          89
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      African
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Number of Intent-to-treat (ITT) participants were included in Baseline analysis. Out of 93 randomized participants (Vd=46; Vcd=47), follow-up data on treatment response was not available for 3 participants, so, they were excluded from the Intent-to-treat (ITT) analysis data set and so, ITT included 90 participants (Vd=43; Vcd=47).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      43
    2. group Id
      BG001
      value
      47
    3. group Id
      BG002
      value
      90
    units
    Participants
groups
  1. description
    Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
    id
    BG000
    title
    Vd (Bortezomib + Dexamethasone)
  2. description
    Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
    id
    BG001
    title
    Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10
          value
          68
        2. group Id
          BG001
          spread
          7
          value
          71
        3. group Id
          BG002
          spread
          9
          value
          69
    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
          18
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          39
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          51
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          89
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      African
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Number of Intent-to-treat (ITT) participants were included in Baseline analysis. Out of 93 randomized participants (Vd=46; Vcd=47), follow-up data on treatment response was not available for 3 participants, so, they were excluded from the Intent-to-treat (ITT) analysis data set and so, ITT included 90 participants (Vd=43; Vcd=47).

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Preserved source evidence · Not medical advice