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NCT02500043 · BASELINE

Baseline characteristics

Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer · Source last updated 2024-09-03

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
      337
    2. group Id
      BG001
      value
      170
    3. group Id
      BG002
      value
      507
    units
    Participants
groups
  1. description
    Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    id
    BG000
    title
    TAS-102+BSC
  2. description
    Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    id
    BG001
    title
    Placebo+BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.78
          value
          62.8
        2. group Id
          BG001
          spread
          10.04
          value
          62.0
        3. group Id
          BG002
          spread
          10.53
          value
          62.5
    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
          85
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          138
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          252
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          369
        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
          244
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          357
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Black/African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          80
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          62
      title
      Not collectable
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          191
      title
      ECOG Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          214
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          316
      title
      ECOG Grade 1
    description
    The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. It ranged on the scale from 0-5 (0 equal to \[=\] normal activity; 1= symptoms but ambulatory; 2= in bed for less than (\<) 50 percent (%) of the time; 3= in bed for greater than (\>) 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG performance status score from baseline was defined as change from 0, 1 to greater than or equal to (\>=2), or from 2 to \>=3.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    European Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
Analysis was performed on the Intent-to-Treat (ITT) population that included all randomized participants, regardless of whether or not study treatment was administered.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      337
    2. group Id
      BG001
      value
      170
    3. group Id
      BG002
      value
      507
    units
    Participants
groups
  1. description
    Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    id
    BG000
    title
    TAS-102+BSC
  2. description
    Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    id
    BG001
    title
    Placebo+BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.78
          value
          62.8
        2. group Id
          BG001
          spread
          10.04
          value
          62.0
        3. group Id
          BG002
          spread
          10.53
          value
          62.5
    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
          85
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          138
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          252
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          369
        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
          244
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          357
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Black/African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          80
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          62
      title
      Not collectable
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          191
      title
      ECOG Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          214
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          316
      title
      ECOG Grade 1
    description
    The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. It ranged on the scale from 0-5 (0 equal to \[=\] normal activity; 1= symptoms but ambulatory; 2= in bed for less than (\<) 50 percent (%) of the time; 3= in bed for greater than (\>) 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG performance status score from baseline was defined as change from 0, 1 to greater than or equal to (\>=2), or from 2 to \>=3.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    European Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
Analysis was performed on the Intent-to-Treat (ITT) population that included all randomized participants, regardless of whether or not study treatment was administered.

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Preserved source evidence · Not medical advice