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NCT02917941 · BASELINE

Baseline characteristics

A Study of Ixazomib Plus Lenalidomide and Dexamethasone in Adult Japanese Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2021-01-12

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
      34
    units
    Participants
groups
  1. description
    Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
    id
    BG000
    title
    Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.57
          value
          65.2
    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
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        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
          34
        title
        Not Hispanic or Latino
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        Asian (Japanese)
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.738
          value
          159.88
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    centimeter (cm)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.444
          value
          60.36
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilogram (kg)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2076
          value
          1.632
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area
    unit Of Measure
    square meter (m^2)
population Description
Full Analysis Set (FAS) is defined as all participants who received at least one dose of the study drug during the treatment period.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      34
    units
    Participants
groups
  1. description
    Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
    id
    BG000
    title
    Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.57
          value
          65.2
    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
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        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
          34
        title
        Not Hispanic or Latino
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        Asian (Japanese)
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.738
          value
          159.88
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    centimeter (cm)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.444
          value
          60.36
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilogram (kg)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2076
          value
          1.632
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area
    unit Of Measure
    square meter (m^2)
population Description
Full Analysis Set (FAS) is defined as all participants who received at least one dose of the study drug during the treatment period.

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Preserved source evidence · Not medical advice