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NCT01271712 · BASELINE

Baseline characteristics

Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST) · Source last updated 2021-01-29

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
      133
    2. group Id
      BG001
      value
      66
    3. group Id
      BG002
      value
      199
    units
    Participants
groups
  1. description
    Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    BG000
    title
    Regorafenib (Stivarga, BAY73-4506)
  2. description
    Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    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
          spread
          12.5
          value
          58.2
        2. group Id
          BG001
          spread
          13.9
          value
          58.1
        3. group Id
          BG002
          spread
          12.9
          value
          58.2
    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
          48
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          72
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          127
        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
          73
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          110
        title
        PS 0
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          89
        title
        PS 1
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        PS 2
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
    description
    ECOG = Eastern cooperative oncology group PS levels are 0 (Fully active, able to carry on all pre-disease performance), 1 (ambulatory and able to carry out work of a light or sedentary), 2 (Ambulatory and capable of all selfcare but unable to carry out any work activities), 3 (Capable of only limited selfcare, confined to bed or chair more than 50% of awake time), 4 (Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair) and 5 (death).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status (PS)]
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          113
        title
        3rd line
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          86
        title
        4th line and beyond
    description
    3rd line: 3rd in sequence of multiple therapies: imatinib (1st); sunitinib (2nd). 4th line and beyond: 4th in sequence of multiple therapies: imatinib (1st); sunitinib (2nd); other (3rd).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior anti-cancer drug group
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      133
    2. group Id
      BG001
      value
      66
    3. group Id
      BG002
      value
      199
    units
    Participants
groups
  1. description
    Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    BG000
    title
    Regorafenib (Stivarga, BAY73-4506)
  2. description
    Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    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
          spread
          12.5
          value
          58.2
        2. group Id
          BG001
          spread
          13.9
          value
          58.1
        3. group Id
          BG002
          spread
          12.9
          value
          58.2
    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
          48
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          72
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          127
        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
          73
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          110
        title
        PS 0
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          89
        title
        PS 1
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        PS 2
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
    description
    ECOG = Eastern cooperative oncology group PS levels are 0 (Fully active, able to carry on all pre-disease performance), 1 (ambulatory and able to carry out work of a light or sedentary), 2 (Ambulatory and capable of all selfcare but unable to carry out any work activities), 3 (Capable of only limited selfcare, confined to bed or chair more than 50% of awake time), 4 (Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair) and 5 (death).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status (PS)]
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          113
        title
        3rd line
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          86
        title
        4th line and beyond
    description
    3rd line: 3rd in sequence of multiple therapies: imatinib (1st); sunitinib (2nd). 4th line and beyond: 4th in sequence of multiple therapies: imatinib (1st); sunitinib (2nd); other (3rd).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior anti-cancer drug group
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice