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NCT01478581 · BASELINE

Baseline characteristics

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2020-03-10

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
      13
    2. group Id
      BG001
      value
      18
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      43
    5. group Id
      BG004
      value
      92
    units
    Participants
groups
  1. description
    PCI-32765 420 mg per day PCI-32765
    id
    BG000
    title
    Cohort 1
  2. description
    PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    BG001
    title
    Cohort 2
  3. description
    PCI-32765 840 mg per day PCI-32765
    id
    BG002
    title
    Cohort 3
  4. description
    PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    BG003
    title
    Cohort 4
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.57
          value
          62.0
        2. group Id
          BG001
          spread
          8.44
          value
          65.5
        3. group Id
          BG002
          spread
          7.52
          value
          65.5
        4. group Id
          BG003
          spread
          7.40
          value
          65.0
        5. group Id
          BG004
          spread
          7.63
          value
          65.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          56
        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
          1
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          34
        5. group Id
          BG004
          value
          82
        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
          3
        5. group Id
          BG004
          value
          3
        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
          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
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Asian
      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
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          67
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          5
        title
        Unknown or Not Reported
      title
      Other Race
    description
    We have 5 patients with Race reported as "Other". For these 5 patients we reported the race data under "Unknown or Not Reported" as no "Other" category available in this database.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          92
      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
      13
    2. group Id
      BG001
      value
      18
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      43
    5. group Id
      BG004
      value
      92
    units
    Participants
groups
  1. description
    PCI-32765 420 mg per day PCI-32765
    id
    BG000
    title
    Cohort 1
  2. description
    PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    BG001
    title
    Cohort 2
  3. description
    PCI-32765 840 mg per day PCI-32765
    id
    BG002
    title
    Cohort 3
  4. description
    PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    BG003
    title
    Cohort 4
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.57
          value
          62.0
        2. group Id
          BG001
          spread
          8.44
          value
          65.5
        3. group Id
          BG002
          spread
          7.52
          value
          65.5
        4. group Id
          BG003
          spread
          7.40
          value
          65.0
        5. group Id
          BG004
          spread
          7.63
          value
          65.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          56
        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
          1
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          34
        5. group Id
          BG004
          value
          82
        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
          3
        5. group Id
          BG004
          value
          3
        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
          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
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Asian
      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
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          67
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          5
        title
        Unknown or Not Reported
      title
      Other Race
    description
    We have 5 patients with Race reported as "Other". For these 5 patients we reported the race data under "Unknown or Not Reported" as no "Other" category available in this database.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          92
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice