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NCT03439293 · BASELINE

Baseline characteristics

A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM) · Source last updated 2024-07-03

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
      61
    units
    Participants
groups
  1. description
    Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
    id
    BG000
    title
    Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.80
          value
          67.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    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
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          55
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          53
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.71
          value
          166.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          60
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for height at Baseline.
    title
    Height
    unit Of Measure
    centimeters (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.625
          value
          80.08
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilograms (kg)
population Description
Safety population included participants who received at least 1 dose of any study treatment regimen.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      61
    units
    Participants
groups
  1. description
    Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
    id
    BG000
    title
    Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.80
          value
          67.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    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
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          55
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          53
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.71
          value
          166.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          60
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for height at Baseline.
    title
    Height
    unit Of Measure
    centimeters (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.625
          value
          80.08
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilograms (kg)
population Description
Safety population included participants who received at least 1 dose of any study treatment regimen.

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Preserved source evidence · Not medical advice