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NCT01962792 · BASELINE

Baseline characteristics

Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2021-12-21

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
      3
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      17
    4. group Id
      BG003
      value
      59
    5. group Id
      BG004
      value
      84
    units
    Participants
groups
  1. description
    Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib
    id
    BG000
    title
    Cohort 1 (560 mg)
  2. description
    Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib
    id
    BG001
    title
    Cohort 2a (560 mg)
  3. description
    Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    BG002
    title
    Cohort 2b (560 mg)
  4. description
    Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    BG003
    title
    All RP2D (840 mg)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. 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
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          46
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          38
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.53
          value
          69.0
        2. group Id
          BG001
          spread
          9.21
          value
          72.0
        3. group Id
          BG002
          spread
          10.29
          value
          60.0
        4. group Id
          BG003
          spread
          9.86
          value
          63.0
        5. group Id
          BG004
          spread
          9.88
          value
          63.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          41
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          43
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          51
        5. group Id
          BG004
          value
          73
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          59
        5. group Id
          BG004
          value
          84
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      17
    4. group Id
      BG003
      value
      59
    5. group Id
      BG004
      value
      84
    units
    Participants
groups
  1. description
    Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib
    id
    BG000
    title
    Cohort 1 (560 mg)
  2. description
    Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib
    id
    BG001
    title
    Cohort 2a (560 mg)
  3. description
    Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    BG002
    title
    Cohort 2b (560 mg)
  4. description
    Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    BG003
    title
    All RP2D (840 mg)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. 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
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          46
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          38
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.53
          value
          69.0
        2. group Id
          BG001
          spread
          9.21
          value
          72.0
        3. group Id
          BG002
          spread
          10.29
          value
          60.0
        4. group Id
          BG003
          spread
          9.86
          value
          63.0
        5. group Id
          BG004
          spread
          9.88
          value
          63.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          41
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          43
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          51
        5. group Id
          BG004
          value
          73
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          59
        5. group Id
          BG004
          value
          84
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice