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NCT02924272 · BASELINE

Baseline characteristics

Ixazomib Rollover Study · Source last updated 2025-03-12

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
      23
    2. group Id
      BG001
      value
      9
    3. group Id
      BG002
      value
      32
    units
    Participants
groups
  1. description
    Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
    id
    BG000
    title
    Ixazomib Monotherapy
  2. description
    Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
    id
    BG001
    title
    Ixazomib Combination Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.45
          value
          75.1
        2. group Id
          BG001
          spread
          9.53
          value
          64.6
        3. group Id
          BG002
          spread
          8.73
          value
          72.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          32
        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
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          32
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
population Description
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      23
    2. group Id
      BG001
      value
      9
    3. group Id
      BG002
      value
      32
    units
    Participants
groups
  1. description
    Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
    id
    BG000
    title
    Ixazomib Monotherapy
  2. description
    Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
    id
    BG001
    title
    Ixazomib Combination Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.45
          value
          75.1
        2. group Id
          BG001
          spread
          9.53
          value
          64.6
        3. group Id
          BG002
          spread
          8.73
          value
          72.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          32
        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
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          32
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
population Description
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.

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Preserved source evidence · Not medical advice