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NCT01607957 · BASELINE

Baseline characteristics

Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies · Source last updated 2024-09-19

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
      534
    2. group Id
      BG001
      value
      266
    3. group Id
      BG002
      value
      800
    units
    Participants
groups
  1. description
    Participants received TAS-102 orally with a starting dose of 35 mg/m\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
    id
    BG000
    title
    TAS-102
  2. description
    Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
    id
    BG001
    title
    Placebo
  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
          300
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          448
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          352
        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
          spread
          10.21
          value
          61.5
        2. group Id
          BG001
          spread
          10.51
          value
          61.5
        3. group Id
          BG002
          spread
          10.30
          value
          61.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          309
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          326
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          491
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Analysis was performed in Intent-to-Treat (ITT) population which included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      534
    2. group Id
      BG001
      value
      266
    3. group Id
      BG002
      value
      800
    units
    Participants
groups
  1. description
    Participants received TAS-102 orally with a starting dose of 35 mg/m\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
    id
    BG000
    title
    TAS-102
  2. description
    Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
    id
    BG001
    title
    Placebo
  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
          300
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          448
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          352
        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
          spread
          10.21
          value
          61.5
        2. group Id
          BG001
          spread
          10.51
          value
          61.5
        3. group Id
          BG002
          spread
          10.30
          value
          61.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          309
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          326
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          491
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Analysis was performed in Intent-to-Treat (ITT) population which included all randomized participants.

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

Preserved source evidence · Independent clinical review pending · Not medical advice