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NCT02048371 · BASELINE

Baseline characteristics

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes · Source last updated 2023-11-07

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
      24
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      22
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      30
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      1
    8. group Id
      BG007
      value
      131
    units
    Participants
groups
  1. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG000
    title
    Cohort A: Liposarcoma
  2. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    BG001
    title
    Cohort A: Liposarcoma, Placebo
  3. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG002
    title
    Cohort B: Osteosarcoma
  4. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    BG003
    title
    Cohort B: Osteosarcoma, Placebo
  5. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG004
    title
    Cohort C: Ewing Sarcoma
  6. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG005
    title
    Cohort D: Rhabdomyosarcoma
  7. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG006
    title
    Cohort E: Mesenchymal Chondrosarcoma
  8. description
    Total of all reporting groups
    id
    BG007
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          102
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          25
        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
          value
          14
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          57
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          74
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          114
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          27
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          99
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      24
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      22
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      30
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      1
    8. group Id
      BG007
      value
      131
    units
    Participants
groups
  1. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG000
    title
    Cohort A: Liposarcoma
  2. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    BG001
    title
    Cohort A: Liposarcoma, Placebo
  3. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG002
    title
    Cohort B: Osteosarcoma
  4. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    BG003
    title
    Cohort B: Osteosarcoma, Placebo
  5. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG004
    title
    Cohort C: Ewing Sarcoma
  6. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG005
    title
    Cohort D: Rhabdomyosarcoma
  7. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    BG006
    title
    Cohort E: Mesenchymal Chondrosarcoma
  8. description
    Total of all reporting groups
    id
    BG007
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          102
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          25
        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
          value
          14
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          57
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          74
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          114
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          27
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          99
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice