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NCT00511238 · BASELINE

Baseline characteristics

Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma · Source last updated 2017-08-31

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
      46
    2. group Id
      BG001
      value
      266
    3. group Id
      BG002
      value
      312
    units
    Participants
groups
  1. description
    Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle
    id
    BG000
    title
    Carfilzomib (A0)
  2. description
    In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
    id
    BG001
    title
    Carfilzomib (A1)
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          172
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          140
        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
          value
          21
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          132
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          155
        3. group Id
          BG002
          value
          180
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population: The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      46
    2. group Id
      BG001
      value
      266
    3. group Id
      BG002
      value
      312
    units
    Participants
groups
  1. description
    Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle
    id
    BG000
    title
    Carfilzomib (A0)
  2. description
    In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
    id
    BG001
    title
    Carfilzomib (A1)
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          172
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          140
        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
          value
          21
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          132
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          155
        3. group Id
          BG002
          value
          180
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population: The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib.

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Preserved source evidence · Not medical advice