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NCT02525692 · BASELINE

Baseline characteristics

Oral ONC201 in Adult Recurrent Glioblastoma · Source last updated 2024-12-24

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
      17
    2. group Id
      BG001
      value
      19
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      30
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      7
    7. group Id
      BG006
      value
      84
    units
    Participants
groups
  1. description
    Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences. Patients received 625 mg oral ONC201 once every 3 weeks.
    id
    BG000
    title
    Arm A
  2. description
    Patients with first recurrence of histologically confirmed WHO Grade IV glioma. Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
    id
    BG001
    title
    Arm B
  3. description
    Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
    id
    BG002
    title
    Arm C
  4. description
    Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed). Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
    id
    BG003
    title
    Arm D
  5. description
    Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
    id
    BG004
    title
    Arm E
  6. description
    Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status. Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
    id
    BG005
    title
    Arm F
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          74
          value
          58.0
        2. group Id
          BG001
          lower Limit
          21
          upper Limit
          75
          value
          56.0
        3. group Id
          BG002
          lower Limit
          48
          upper Limit
          80
          value
          66.5
        4. group Id
          BG003
          lower Limit
          17
          upper Limit
          53
          value
          35.0
        5. group Id
          BG004
          lower Limit
          26
          upper Limit
          40
          value
          37.0
        6. group Id
          BG005
          lower Limit
          30
          upper Limit
          60
          value
          50.0
        7. group Id
          BG006
          lower Limit
          17
          upper Limit
          80
          value
          48.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          43
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          41
        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
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          72
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        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
          5
        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
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          3
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          72
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          12
      title
      Brainstem
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          32
      title
      Midline ex-brainstem
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          40
      title
      Non-midline
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Location
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      17
    2. group Id
      BG001
      value
      19
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      30
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      7
    7. group Id
      BG006
      value
      84
    units
    Participants
groups
  1. description
    Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences. Patients received 625 mg oral ONC201 once every 3 weeks.
    id
    BG000
    title
    Arm A
  2. description
    Patients with first recurrence of histologically confirmed WHO Grade IV glioma. Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
    id
    BG001
    title
    Arm B
  3. description
    Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
    id
    BG002
    title
    Arm C
  4. description
    Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed). Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
    id
    BG003
    title
    Arm D
  5. description
    Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
    id
    BG004
    title
    Arm E
  6. description
    Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status. Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
    id
    BG005
    title
    Arm F
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          74
          value
          58.0
        2. group Id
          BG001
          lower Limit
          21
          upper Limit
          75
          value
          56.0
        3. group Id
          BG002
          lower Limit
          48
          upper Limit
          80
          value
          66.5
        4. group Id
          BG003
          lower Limit
          17
          upper Limit
          53
          value
          35.0
        5. group Id
          BG004
          lower Limit
          26
          upper Limit
          40
          value
          37.0
        6. group Id
          BG005
          lower Limit
          30
          upper Limit
          60
          value
          50.0
        7. group Id
          BG006
          lower Limit
          17
          upper Limit
          80
          value
          48.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          43
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          41
        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
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          72
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        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
          5
        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
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          3
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          72
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          12
      title
      Brainstem
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          32
      title
      Midline ex-brainstem
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          40
      title
      Non-midline
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Location
    unit Of Measure
    Participants

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