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NCT02130557 · BASELINE

Baseline characteristics

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia · Source last updated 2021-05-18

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
      268
    2. group Id
      BG001
      value
      268
    3. group Id
      BG002
      value
      536
    units
    Participants
groups
  1. description
    Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
    id
    BG000
    title
    Bosutinib
  2. description
    Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
    id
    BG001
    title
    Imatinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.40
          value
          50.8
        2. group Id
          BG001
          spread
          14.43
          value
          50.9
        3. group Id
          BG002
          spread
          14.91
          value
          50.9
    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
          112
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          225
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          155
        3. group Id
          BG002
          value
          311
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-to-treat population: All randomized participants with study drug assignments designated according to initial randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      268
    2. group Id
      BG001
      value
      268
    3. group Id
      BG002
      value
      536
    units
    Participants
groups
  1. description
    Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
    id
    BG000
    title
    Bosutinib
  2. description
    Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
    id
    BG001
    title
    Imatinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.40
          value
          50.8
        2. group Id
          BG001
          spread
          14.43
          value
          50.9
        3. group Id
          BG002
          spread
          14.91
          value
          50.9
    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
          112
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          225
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          155
        3. group Id
          BG002
          value
          311
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-to-treat population: All randomized participants with study drug assignments designated according to initial randomization.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice