Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02312258 · BASELINE

Baseline characteristics

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2023-09-21

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
      281
    2. group Id
      BG001
      value
      425
    3. group Id
      BG002
      value
      706
    units
    Participants
groups
  1. description
    Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
    id
    BG000
    title
    Placebo
  2. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    BG001
    title
    Ixazomib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.77
          value
          72.8
        2. group Id
          BG001
          spread
          6.87
          value
          72.3
        3. group Id
          BG002
          spread
          6.83
          value
          72.5
    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
          126
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          329
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          222
        3. group Id
          BG002
          value
          377
        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
          36
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          82
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          237
        2. group Id
          BG001
          value
          366
        3. group Id
          BG002
          value
          603
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          102
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          20
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          227
        2. group Id
          BG001
          value
          330
        3. group Id
          BG002
          value
          557
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          20
      title
      Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      China
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          32
      title
      Japan
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
      title
      Singapore
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          27
      title
      Korea, Republic Of
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      Taiwan, Province Of China
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
      title
      Thailand
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Austria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Belgium
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          69
      title
      Czech Republic
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      title
      Denmark
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
      title
      France
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) Population included all participants who were randomized and had post-randomization data.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      281
    2. group Id
      BG001
      value
      425
    3. group Id
      BG002
      value
      706
    units
    Participants
groups
  1. description
    Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
    id
    BG000
    title
    Placebo
  2. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    BG001
    title
    Ixazomib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.77
          value
          72.8
        2. group Id
          BG001
          spread
          6.87
          value
          72.3
        3. group Id
          BG002
          spread
          6.83
          value
          72.5
    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
          126
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          329
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          222
        3. group Id
          BG002
          value
          377
        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
          36
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          82
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          237
        2. group Id
          BG001
          value
          366
        3. group Id
          BG002
          value
          603
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          102
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          20
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          227
        2. group Id
          BG001
          value
          330
        3. group Id
          BG002
          value
          557
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          20
      title
      Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      China
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          32
      title
      Japan
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
      title
      Singapore
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          27
      title
      Korea, Republic Of
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      Taiwan, Province Of China
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
      title
      Thailand
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Austria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Belgium
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          69
      title
      Czech Republic
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      title
      Denmark
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
      title
      France
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) Population included all participants who were randomized and had post-randomization data.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice