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NCT01302392 · BASELINE

Baseline characteristics

A Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2017-05-02

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
      158
    2. group Id
      BG001
      value
      157
    3. group Id
      BG002
      value
      315
    units
    Participants
groups
  1. description
    Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid). Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle).
    id
    BG000
    title
    Best Supportive Care
  2. description
    Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \[Days 1, 2, 8, 9, 15, 16\] for individual subjects).
    id
    BG001
    title
    Carfilzomib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.02
          value
          65.5
        2. group Id
          BG001
          spread
          10.71
          value
          63.3
        3. group Id
          BG002
          spread
          9.50
          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
          62
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          137
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          178
        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
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          299
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          278
      title
      Europe
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          37
      title
      Non-Europe
    param Type
    NUMBER
    title
    Region
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
      title
      3
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          69
      title
      4
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          210
      title
      ≥5
    param Type
    NUMBER
    title
    Number of Prior Regimens to Treat Multiple Myeloma
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      158
    2. group Id
      BG001
      value
      157
    3. group Id
      BG002
      value
      315
    units
    Participants
groups
  1. description
    Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid). Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle).
    id
    BG000
    title
    Best Supportive Care
  2. description
    Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \[Days 1, 2, 8, 9, 15, 16\] for individual subjects).
    id
    BG001
    title
    Carfilzomib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.02
          value
          65.5
        2. group Id
          BG001
          spread
          10.71
          value
          63.3
        3. group Id
          BG002
          spread
          9.50
          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
          62
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          137
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          178
        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
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          299
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          278
      title
      Europe
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          37
      title
      Non-Europe
    param Type
    NUMBER
    title
    Region
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
      title
      3
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          69
      title
      4
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          210
      title
      ≥5
    param Type
    NUMBER
    title
    Number of Prior Regimens to Treat Multiple Myeloma
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice