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NCT00724568 · BASELINE

Baseline characteristics

Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma · Source last updated 2017-06-02

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
      72
    units
    Participants
groups
  1. description
    Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
    id
    BG000
    title
    Combination Drug Therapy
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          29
          upper Limit
          77
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
A total of 74 patients were enrolled in this phase 1/2 study. 2 patients were not evaluable for the Dose Limiting Toxicity (DLT) and therefore only 72 are included in the baseline analysis population.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      72
    units
    Participants
groups
  1. description
    Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
    id
    BG000
    title
    Combination Drug Therapy
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          29
          upper Limit
          77
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
A total of 74 patients were enrolled in this phase 1/2 study. 2 patients were not evaluable for the Dose Limiting Toxicity (DLT) and therefore only 72 are included in the baseline analysis population.

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Preserved source evidence · Not medical advice