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NCT00009737 · BASELINE

Baseline characteristics

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer · Source last updated 2016-06-22

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
      1004
    2. group Id
      BG001
      value
      983
    3. group Id
      BG002
      value
      1987
    units
    Participants
groups
  1. description
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    id
    BG000
    title
    Capecitabine
  2. description
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    id
    BG001
    title
    5-Fluorouracil + Leucovorin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          25
          upper Limit
          80
          value
          62.0
        2. group Id
          BG001
          lower Limit
          22
          upper Limit
          82
          value
          63.0
        3. group Id
          BG002
          lower Limit
          22
          upper Limit
          82
          value
          62.0
    description
    For median age, summary is based on n=1985
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          461
        2. group Id
          BG001
          value
          451
        3. group Id
          BG002
          value
          912
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          542
        2. group Id
          BG001
          value
          532
        3. group Id
          BG002
          value
          1074
      title
      Male
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    Participants
population Description
All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1004
    2. group Id
      BG001
      value
      983
    3. group Id
      BG002
      value
      1987
    units
    Participants
groups
  1. description
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    id
    BG000
    title
    Capecitabine
  2. description
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    id
    BG001
    title
    5-Fluorouracil + Leucovorin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          25
          upper Limit
          80
          value
          62.0
        2. group Id
          BG001
          lower Limit
          22
          upper Limit
          82
          value
          63.0
        3. group Id
          BG002
          lower Limit
          22
          upper Limit
          82
          value
          62.0
    description
    For median age, summary is based on n=1985
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          461
        2. group Id
          BG001
          value
          451
        3. group Id
          BG002
          value
          912
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          542
        2. group Id
          BG001
          value
          532
        3. group Id
          BG002
          value
          1074
      title
      Male
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    Participants
population Description
All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.

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Preserved source evidence · Not medical advice