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NCT03353753 · BASELINE

Baseline characteristics

Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies · Source last updated 2022-11-21

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
      85
    2. group Id
      BG001
      value
      44
    3. group Id
      BG002
      value
      129
    units
    Participants
groups
  1. description
    Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
    id
    BG000
    title
    Ripretinib
  2. description
    Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
    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
          57
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          79
        title
        18 - 64 Years
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          32
        title
        65 - 74 Years
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          18
        title
        75 Years or Older
      title
      Age Category (years)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          73
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          114
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          97
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        Not Reported
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          60
        title
        US
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          69
        title
        Non-US
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          81
        title
        3
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          48
        title
        ≥ 4
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Systemic Anticancer Treatments
    unit Of Measure
    Participants
population Description
The baseline analysis population was the intent-to-treat (ITT) population, defined as those who signed the ICF and were randomized
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      85
    2. group Id
      BG001
      value
      44
    3. group Id
      BG002
      value
      129
    units
    Participants
groups
  1. description
    Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
    id
    BG000
    title
    Ripretinib
  2. description
    Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
    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
          57
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          79
        title
        18 - 64 Years
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          32
        title
        65 - 74 Years
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          18
        title
        75 Years or Older
      title
      Age Category (years)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          73
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          114
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          97
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        Not Reported
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          60
        title
        US
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          69
        title
        Non-US
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          81
        title
        3
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          48
        title
        ≥ 4
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Systemic Anticancer Treatments
    unit Of Measure
    Participants
population Description
The baseline analysis population was the intent-to-treat (ITT) population, defined as those who signed the ICF and were randomized

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Preserved source evidence · Not medical advice