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NCT01217957 · BASELINE

Baseline characteristics

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-03-14

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      50
    6. group Id
      BG005
      value
      65
    units
    Participants
groups
  1. description
    In phase 1, ixazomib 1.68 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
  2. description
    In phase 1, ixazomib 2.23 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG001
    title
    Phase 1 :Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
  3. description
    In phase 1, ixazomib 2.97 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG002
    title
    Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
  4. description
    In phase 1, ixazomib 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG003
    title
    Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone
  5. description
    In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG004
    title
    Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.21
          value
          62.7
        2. group Id
          BG001
          spread
          4.51
          value
          72.3
        3. group Id
          BG002
          spread
          12.19
          value
          63.2
        4. group Id
          BG003
          spread
          9.29
          value
          64.7
        5. group Id
          BG004
          spread
          11.16
          value
          64.2
        6. group Id
          BG005
          spread
          10.67
          value
          64.4
    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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          36
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          64
      title
      Not Hispanic or Latino
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          42
        6. group Id
          BG005
          value
          52
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          12
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          50
        6. group Id
          BG005
          value
          65
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          50
        6. group Id
          BG005
          value
          65
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.90
          value
          168.9
        2. group Id
          BG001
          spread
          3.20
          value
          155.4
        3. group Id
          BG002
          spread
          10.21
          value
          165.9
        4. group Id
          BG003
          spread
          8.07
          value
          171.1
        5. group Id
          BG004
          spread
          11.57
          value
          169.4
        6. group Id
          BG005
          spread
          11.30
          value
          168.5
    description
    Height data was available for 3, 3, 6, 3, 48 and 51 participants in each treatment arm, respectively.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.683
          value
          87.43
        2. group Id
          BG001
          spread
          16.045
          value
          64.93
        3. group Id
          BG002
          spread
          14.557
          value
          72.82
        4. group Id
          BG003
          spread
          25.480
          value
          116.63
        5. group Id
          BG004
          spread
          17.695
          value
          86.13
        6. group Id
          BG005
          spread
          19.247
          value
          85.39
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2180
          value
          2.024
        2. group Id
          BG001
          spread
          0.1923
          value
          1.665
        3. group Id
          BG002
          spread
          0.2272
          value
          1.826
        4. group Id
          BG003
          spread
          0.3050
          value
          2.348
        5. group Id
          BG004
          spread
          0.2343
          value
          2.011
        6. group Id
          BG005
          spread
          0.2565
          value
          1.994
    description
    Body surface area is defined as \[Height(cm) x Weight (kg)\]/3600)\^1/2. Body surface area data was available for 3, 3, 6, 3, 48 and 51 participants in each treatment arm, respectively.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area
    unit Of Measure
    m^2
population Description
Safety Analysis Population: all participants who received at least one dose of any of the 3 study drugs.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      50
    6. group Id
      BG005
      value
      65
    units
    Participants
groups
  1. description
    In phase 1, ixazomib 1.68 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
  2. description
    In phase 1, ixazomib 2.23 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG001
    title
    Phase 1 :Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
  3. description
    In phase 1, ixazomib 2.97 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG002
    title
    Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
  4. description
    In phase 1, ixazomib 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG003
    title
    Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone
  5. description
    In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG004
    title
    Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.21
          value
          62.7
        2. group Id
          BG001
          spread
          4.51
          value
          72.3
        3. group Id
          BG002
          spread
          12.19
          value
          63.2
        4. group Id
          BG003
          spread
          9.29
          value
          64.7
        5. group Id
          BG004
          spread
          11.16
          value
          64.2
        6. group Id
          BG005
          spread
          10.67
          value
          64.4
    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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          36
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          64
      title
      Not Hispanic or Latino
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          42
        6. group Id
          BG005
          value
          52
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          12
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          50
        6. group Id
          BG005
          value
          65
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          50
        6. group Id
          BG005
          value
          65
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.90
          value
          168.9
        2. group Id
          BG001
          spread
          3.20
          value
          155.4
        3. group Id
          BG002
          spread
          10.21
          value
          165.9
        4. group Id
          BG003
          spread
          8.07
          value
          171.1
        5. group Id
          BG004
          spread
          11.57
          value
          169.4
        6. group Id
          BG005
          spread
          11.30
          value
          168.5
    description
    Height data was available for 3, 3, 6, 3, 48 and 51 participants in each treatment arm, respectively.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.683
          value
          87.43
        2. group Id
          BG001
          spread
          16.045
          value
          64.93
        3. group Id
          BG002
          spread
          14.557
          value
          72.82
        4. group Id
          BG003
          spread
          25.480
          value
          116.63
        5. group Id
          BG004
          spread
          17.695
          value
          86.13
        6. group Id
          BG005
          spread
          19.247
          value
          85.39
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2180
          value
          2.024
        2. group Id
          BG001
          spread
          0.1923
          value
          1.665
        3. group Id
          BG002
          spread
          0.2272
          value
          1.826
        4. group Id
          BG003
          spread
          0.3050
          value
          2.348
        5. group Id
          BG004
          spread
          0.2343
          value
          2.011
        6. group Id
          BG005
          spread
          0.2565
          value
          1.994
    description
    Body surface area is defined as \[Height(cm) x Weight (kg)\]/3600)\^1/2. Body surface area data was available for 3, 3, 6, 3, 48 and 51 participants in each treatment arm, respectively.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area
    unit Of Measure
    m^2
population Description
Safety Analysis Population: all participants who received at least one dose of any of the 3 study drugs.

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