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NCT01096342 · BASELINE

Baseline characteristics

Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2014-06-18

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
      15
    units
    Participants
groups
  1. description
    Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Phase II
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          55
          upper Limit
          81
          value
          64
    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
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        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
          12
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Singapore
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
A total of sixteen participants were accrued to the 50 mg/m\^2 after the December 30, 2009 amendment (6 at MTD plus 10 phase II) and were grouped together as Phase II. Of these 16 particpants, one participant was excluded due to a major treatment violation.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      15
    units
    Participants
groups
  1. description
    Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Phase II
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          55
          upper Limit
          81
          value
          64
    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
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        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
          12
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Singapore
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
A total of sixteen participants were accrued to the 50 mg/m\^2 after the December 30, 2009 amendment (6 at MTD plus 10 phase II) and were grouped together as Phase II. Of these 16 particpants, one participant was excluded due to a major treatment violation.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice