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NCT00433550 · BASELINE

Baseline characteristics

Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer · Source last updated 2017-08-24

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
      17
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      33
    units
    Participants
groups
  1. description
    Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    BG000
    title
    Group 1 (6/6 UGT1A1 Genotype)
  2. description
    Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    BG001
    title
    Group 2 (6/7 UGT1A1 Genotype)
  3. description
    Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    BG002
    title
    Group 3 (7/7 UGT1A1 Genotype)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41
          upper Limit
          75
          value
          64
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          77
          value
          66.5
        3. group Id
          BG002
          lower Limit
          43
          upper Limit
          74
          value
          62.5
        4. group Id
          BG003
          lower Limit
          41
          upper Limit
          77
          value
          64
    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
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          24
        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
          17
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          33
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All patients registered were analyzed for baseline characteristics.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      17
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      33
    units
    Participants
groups
  1. description
    Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    BG000
    title
    Group 1 (6/6 UGT1A1 Genotype)
  2. description
    Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    BG001
    title
    Group 2 (6/7 UGT1A1 Genotype)
  3. description
    Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    BG002
    title
    Group 3 (7/7 UGT1A1 Genotype)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41
          upper Limit
          75
          value
          64
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          77
          value
          66.5
        3. group Id
          BG002
          lower Limit
          43
          upper Limit
          74
          value
          62.5
        4. group Id
          BG003
          lower Limit
          41
          upper Limit
          77
          value
          64
    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
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          24
        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
          17
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          33
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All patients registered were analyzed for baseline characteristics.

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Preserved source evidence · Not medical advice