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NCT03465722 · BASELINE

Baseline characteristics

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST · Source last updated 2022-10-06

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
      240
    2. group Id
      BG001
      value
      236
    3. group Id
      BG002
      value
      476
    units
    Participants
groups
  1. description
    300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
    id
    BG000
    title
    Avapritinib
  2. description
    160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
    id
    BG001
    title
    Regorafinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.96
          value
          61.1
        2. group Id
          BG001
          spread
          10.74
          value
          61.0
        3. group Id
          BG002
          spread
          10.84
          value
          61.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
    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
          78
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          158
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          318
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          282
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          50
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Singapore
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          133
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Czechia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Spain
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Canada
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Austria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Netherlands
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          43
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      South Korea
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Sweden
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Belgium
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.563
          value
          25.50
        2. group Id
          BG001
          spread
          5.163
          value
          24.69
        3. group Id
          BG002
          spread
          5.378
          value
          25.10
      denoms
      1. counts
        1. group Id
          BG000
          value
          230
        2. group Id
          BG001
          value
          225
        3. group Id
          BG002
          value
          455
        units
        Participants
    description
    Both height and weight measurements are needed for body mass index calculation. Some patients had missing height and/or weight measurements. Only patients with both a height and a weight measurement are included in the body mass index calculation
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Both height and weight measurements are needed for body mass index calculation. Some patients had missing height and/or weight measurements. Only patients with both a height and a weight measurement are included in the body mass index calculation
    title
    Body Mass Index (BMI)
    unit Of Measure
    kilogram per meter square
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      240
    2. group Id
      BG001
      value
      236
    3. group Id
      BG002
      value
      476
    units
    Participants
groups
  1. description
    300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
    id
    BG000
    title
    Avapritinib
  2. description
    160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
    id
    BG001
    title
    Regorafinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.96
          value
          61.1
        2. group Id
          BG001
          spread
          10.74
          value
          61.0
        3. group Id
          BG002
          spread
          10.84
          value
          61.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
    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
          78
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          158
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          318
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          282
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          50
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Singapore
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          133
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Czechia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Spain
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Canada
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Austria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Netherlands
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          43
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      South Korea
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Sweden
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          240
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          476
        units
        Participants
      title
      Belgium
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.563
          value
          25.50
        2. group Id
          BG001
          spread
          5.163
          value
          24.69
        3. group Id
          BG002
          spread
          5.378
          value
          25.10
      denoms
      1. counts
        1. group Id
          BG000
          value
          230
        2. group Id
          BG001
          value
          225
        3. group Id
          BG002
          value
          455
        units
        Participants
    description
    Both height and weight measurements are needed for body mass index calculation. Some patients had missing height and/or weight measurements. Only patients with both a height and a weight measurement are included in the body mass index calculation
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Both height and weight measurements are needed for body mass index calculation. Some patients had missing height and/or weight measurements. Only patients with both a height and a weight measurement are included in the body mass index calculation
    title
    Body Mass Index (BMI)
    unit Of Measure
    kilogram per meter square

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Preserved source evidence · Not medical advice