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NCT01445080 · BASELINE

Baseline characteristics

Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia · Source last updated 2021-02-02

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
      7
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      8
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      2
    8. group Id
      BG007
      value
      5
    9. group Id
      BG008
      value
      18
    10. group Id
      BG009
      value
      70
    units
    Participants
groups
  1. description
    Patients receive oral sorafenib 105 mg/m\^2 every 12 hours
    id
    BG000
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
  2. description
    Patients receive oral sorafenib 130 mg/m\^2 every 12 hours
    id
    BG001
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
  3. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours
    id
    BG002
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
  4. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours
    id
    BG003
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
  5. description
    Patients receive oral sorafenib 250 mg/m\^2 every 12 hours
    id
    BG004
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
  6. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours
    id
    BG005
    title
    Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
  7. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours
    id
    BG006
    title
    Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
  8. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours
    id
    BG007
    title
    Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2
  9. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours
    id
    BG008
    title
    PK Cohort Expanded: BAY 43-9006 200 mg/m^2
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          15
        10. group Id
          BG009
          value
          60
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          10
        title
        Between 18 and 65 years
      3. 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
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        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
          lower Limit
          9
          upper Limit
          21
          value
          17
        2. group Id
          BG001
          lower Limit
          14
          upper Limit
          18
          value
          16
        3. group Id
          BG002
          lower Limit
          5
          upper Limit
          21
          value
          13.5
        4. group Id
          BG003
          lower Limit
          6
          upper Limit
          21
          value
          13.5
        5. group Id
          BG004
          lower Limit
          6
          upper Limit
          14
          value
          11.5
        6. group Id
          BG005
          lower Limit
          6
          upper Limit
          19
          value
          13
        7. group Id
          BG006
          lower Limit
          6
          upper Limit
          15
          value
          10.5
        8. group Id
          BG007
          lower Limit
          4
          upper Limit
          18
          value
          12
        9. group Id
          BG008
          lower Limit
          5
          upper Limit
          21
          value
          14.5
        10. group Id
          BG009
          lower Limit
          4
          upper Limit
          24
          value
          14
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          47
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          56
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        title
        Asian
      3. 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
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          15
        10. group Id
          BG009
          value
          52
        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
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        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
      7
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      8
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      2
    8. group Id
      BG007
      value
      5
    9. group Id
      BG008
      value
      18
    10. group Id
      BG009
      value
      70
    units
    Participants
groups
  1. description
    Patients receive oral sorafenib 105 mg/m\^2 every 12 hours
    id
    BG000
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
  2. description
    Patients receive oral sorafenib 130 mg/m\^2 every 12 hours
    id
    BG001
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
  3. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours
    id
    BG002
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
  4. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours
    id
    BG003
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
  5. description
    Patients receive oral sorafenib 250 mg/m\^2 every 12 hours
    id
    BG004
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
  6. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours
    id
    BG005
    title
    Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
  7. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours
    id
    BG006
    title
    Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
  8. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours
    id
    BG007
    title
    Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2
  9. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours
    id
    BG008
    title
    PK Cohort Expanded: BAY 43-9006 200 mg/m^2
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          15
        10. group Id
          BG009
          value
          60
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          10
        title
        Between 18 and 65 years
      3. 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
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        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
          lower Limit
          9
          upper Limit
          21
          value
          17
        2. group Id
          BG001
          lower Limit
          14
          upper Limit
          18
          value
          16
        3. group Id
          BG002
          lower Limit
          5
          upper Limit
          21
          value
          13.5
        4. group Id
          BG003
          lower Limit
          6
          upper Limit
          21
          value
          13.5
        5. group Id
          BG004
          lower Limit
          6
          upper Limit
          14
          value
          11.5
        6. group Id
          BG005
          lower Limit
          6
          upper Limit
          19
          value
          13
        7. group Id
          BG006
          lower Limit
          6
          upper Limit
          15
          value
          10.5
        8. group Id
          BG007
          lower Limit
          4
          upper Limit
          18
          value
          12
        9. group Id
          BG008
          lower Limit
          5
          upper Limit
          21
          value
          14.5
        10. group Id
          BG009
          lower Limit
          4
          upper Limit
          24
          value
          14
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          47
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          56
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        title
        Asian
      3. 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
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          15
        10. group Id
          BG009
          value
          52
        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
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        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