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NCT00069121 · BASELINE

Baseline characteristics

A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer · Source last updated 2020-03-06

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
      942
    2. group Id
      BG001
      value
      944
    3. group Id
      BG002
      value
      1886
    units
    Participants
groups
  1. description
    Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
    id
    BG000
    title
    5-FU/LV
  2. description
    Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
    id
    BG001
    title
    XELOX
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.76
          value
          60.5
        2. group Id
          BG001
          spread
          10.95
          value
          59.8
        3. group Id
          BG002
          spread
          10.86
          value
          60.2
    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
          442
        2. group Id
          BG001
          value
          431
        3. group Id
          BG002
          value
          873
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          500
        2. group Id
          BG001
          value
          513
        3. group Id
          BG002
          value
          1013
        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
          442
        2. group Id
          BG001
          value
          431
        3. group Id
          BG002
          value
          873
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          500
        2. group Id
          BG001
          value
          513
        3. group Id
          BG002
          value
          1013
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      942
    2. group Id
      BG001
      value
      944
    3. group Id
      BG002
      value
      1886
    units
    Participants
groups
  1. description
    Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
    id
    BG000
    title
    5-FU/LV
  2. description
    Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
    id
    BG001
    title
    XELOX
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.76
          value
          60.5
        2. group Id
          BG001
          spread
          10.95
          value
          59.8
        3. group Id
          BG002
          spread
          10.86
          value
          60.2
    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
          442
        2. group Id
          BG001
          value
          431
        3. group Id
          BG002
          value
          873
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          500
        2. group Id
          BG001
          value
          513
        3. group Id
          BG002
          value
          1013
        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
          442
        2. group Id
          BG001
          value
          431
        3. group Id
          BG002
          value
          873
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          500
        2. group Id
          BG001
          value
          513
        3. group Id
          BG002
          value
          1013
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice