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NCT01830816 · BASELINE

Baseline characteristics

Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment · Source last updated 2019-06-10

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
      20
    2. group Id
      BG001
      value
      14
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      41
    units
    Participants
groups
  1. description
    Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Normal Renal Function: Ixazomib
  2. description
    Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
    id
    BG001
    title
    Severe Renal Impairment: Ixazomib
  3. description
    Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
    id
    BG002
    title
    End-stage Renal Disease: Ixazomib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.01
          value
          54.5
        2. group Id
          BG001
          spread
          7.35
          value
          72.1
        3. group Id
          BG002
          spread
          12.65
          value
          61.3
        4. group Id
          BG003
          spread
          12.01
          value
          61.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        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
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          25
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          16
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        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
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          35
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          27
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          12
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.28
          value
          173.2
        2. group Id
          BG001
          spread
          8.49
          value
          160.8
        3. group Id
          BG002
          spread
          9.61
          value
          160.3
        4. group Id
          BG003
          spread
          11.76
          value
          167.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          39
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for height.
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          27.66
          value
          98.1
        2. group Id
          BG001
          spread
          14.70
          value
          60.7
        3. group Id
          BG002
          spread
          27.11
          value
          86.0
        4. group Id
          BG003
          spread
          28.85
          value
          83.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
population Description
Safety population is defined as participants who received at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      20
    2. group Id
      BG001
      value
      14
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      41
    units
    Participants
groups
  1. description
    Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Normal Renal Function: Ixazomib
  2. description
    Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
    id
    BG001
    title
    Severe Renal Impairment: Ixazomib
  3. description
    Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
    id
    BG002
    title
    End-stage Renal Disease: Ixazomib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.01
          value
          54.5
        2. group Id
          BG001
          spread
          7.35
          value
          72.1
        3. group Id
          BG002
          spread
          12.65
          value
          61.3
        4. group Id
          BG003
          spread
          12.01
          value
          61.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        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
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          25
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          16
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        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
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          35
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          27
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          12
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.28
          value
          173.2
        2. group Id
          BG001
          spread
          8.49
          value
          160.8
        3. group Id
          BG002
          spread
          9.61
          value
          160.3
        4. group Id
          BG003
          spread
          11.76
          value
          167.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          39
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for height.
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          27.66
          value
          98.1
        2. group Id
          BG001
          spread
          14.70
          value
          60.7
        3. group Id
          BG002
          spread
          27.11
          value
          86.0
        4. group Id
          BG003
          spread
          28.85
          value
          83.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          41
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
population Description
Safety population is defined as participants who received at least 1 dose of study drug.

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

Preserved source evidence · Not medical advice