Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03433001 · BASELINE

Baseline characteristics

A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone · Source last updated 2023-12-07

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
      295
    units
    Participants
groups
  1. description
    Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
    id
    BG000
    title
    Ixazomib + Lenalidomide + Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.62
          value
          71.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        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
          127
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          168
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          295
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Japan
    description
    All participants were enrolled in Japan.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.70
          value
          157.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          288
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Hight
    unit Of Measure
    Centimeters (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.122
          value
          56.91
      denoms
      1. counts
        1. group Id
          BG000
          value
          277
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Weight
    unit Of Measure
    Kilograms (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.353
          value
          22.96
      denoms
      1. counts
        1. group Id
          BG000
          value
          276
        units
        Participants
    description
    Body Mass Index = weight (kg)/\[height (m)\^2\]
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    BMI
    unit Of Measure
    Kilogram (kg)/meter (m)^2]
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1830
          value
          1.562
      denoms
      1. counts
        1. group Id
          BG000
          value
          276
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Body Surface Area
    unit Of Measure
    m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          101
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Missing
    description
    International Staging System is a staging system for cancer progression. Stages are classified by Stage I to Stage III. Stage I: Serum beta2-microglobulin \<3.5 mg/L and albumin ≥3.5 g/dL; Stage II: Neither Stage I or III, meaning that either: beta2-microglobulin level ≥3.5 and \<5.5 mg/L (with any albumin level), OR albumin \<3.5 g/dL with beta2-microglobulin \<3.5 mg/L; Stage III: Serum beta2-microglobulin ≥5.5 mg/L. Normal serum beta2-microglobulin: \<3.0 mg/L; normal albumin: 3.5-5.0 g/dL.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (at Initial Diagnosis)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          130
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          78
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          56
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (at First Treatment)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          147
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          90
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      4
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Missing
    description
    ECOG P.S. assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory ( greater than \[\>\] 50 percent \[%\] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group performance status (ECOG P.S.)
    unit Of Measure
    Participants
population Description
Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      295
    units
    Participants
groups
  1. description
    Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
    id
    BG000
    title
    Ixazomib + Lenalidomide + Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.62
          value
          71.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        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
          127
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          168
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          295
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Japan
    description
    All participants were enrolled in Japan.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.70
          value
          157.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          288
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Hight
    unit Of Measure
    Centimeters (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.122
          value
          56.91
      denoms
      1. counts
        1. group Id
          BG000
          value
          277
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Weight
    unit Of Measure
    Kilograms (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.353
          value
          22.96
      denoms
      1. counts
        1. group Id
          BG000
          value
          276
        units
        Participants
    description
    Body Mass Index = weight (kg)/\[height (m)\^2\]
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    BMI
    unit Of Measure
    Kilogram (kg)/meter (m)^2]
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1830
          value
          1.562
      denoms
      1. counts
        1. group Id
          BG000
          value
          276
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Body Surface Area
    unit Of Measure
    m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          101
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Missing
    description
    International Staging System is a staging system for cancer progression. Stages are classified by Stage I to Stage III. Stage I: Serum beta2-microglobulin \<3.5 mg/L and albumin ≥3.5 g/dL; Stage II: Neither Stage I or III, meaning that either: beta2-microglobulin level ≥3.5 and \<5.5 mg/L (with any albumin level), OR albumin \<3.5 g/dL with beta2-microglobulin \<3.5 mg/L; Stage III: Serum beta2-microglobulin ≥5.5 mg/L. Normal serum beta2-microglobulin: \<3.0 mg/L; normal albumin: 3.5-5.0 g/dL.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (at Initial Diagnosis)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          130
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          78
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          56
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (at First Treatment)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          147
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          90
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      4
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          295
        units
        Participants
      title
      Missing
    description
    ECOG P.S. assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory ( greater than \[\>\] 50 percent \[%\] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group performance status (ECOG P.S.)
    unit Of Measure
    Participants
population Description
Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.

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

Preserved source evidence · Not medical advice