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NCT01645930 · BASELINE

Baseline characteristics

Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2018-11-08

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
    units
    Participants
groups
  1. description
    Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
    id
    BG000
    title
    Ixazomib+Lenalidomide+Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.84
          value
          61.5
    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
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        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
          43
      title
      Not Hispanic or Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
      title
      Asian
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      Singapore
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Hong Kong
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Korea, Republic Of
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.80
          value
          160.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height at Baseline
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.47
          value
          60.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight at Baseline
    unit Of Measure
    kg
population Description
Safety Population included all participants who received at least one dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      43
    units
    Participants
groups
  1. description
    Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
    id
    BG000
    title
    Ixazomib+Lenalidomide+Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.84
          value
          61.5
    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
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        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
          43
      title
      Not Hispanic or Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
      title
      Asian
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      Singapore
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Hong Kong
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Korea, Republic Of
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.80
          value
          160.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height at Baseline
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.47
          value
          60.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight at Baseline
    unit Of Measure
    kg
population Description
Safety Population included all participants who received at least one dose of study drug.

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Preserved source evidence · Not medical advice