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NCT02039947 · BASELINE

Baseline characteristics

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain · Source last updated 2019-05-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      76
    2. group Id
      BG001
      value
      16
    3. group Id
      BG002
      value
      16
    4. group Id
      BG003
      value
      17
    5. group Id
      BG004
      value
      125
    units
    Participants
groups
  1. description
    Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
    id
    BG000
    title
    Cohort A
  2. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    BG001
    title
    Cohort B
  3. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    BG002
    title
    Cohort C
  4. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    BG003
    title
    Cohort D
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.69
          value
          53.2
        2. group Id
          BG001
          spread
          11.05
          value
          55.1
        3. group Id
          BG002
          spread
          10.40
          value
          65.6
        4. group Id
          BG003
          spread
          13.01
          value
          47.5
        5. group Id
          BG004
          spread
          14.29
          value
          54.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          53
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          72
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          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
          0
        5. group Id
          BG004
          value
          0
        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
        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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          125
        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
        title
        More than one race
      7. 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
        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
      76
    2. group Id
      BG001
      value
      16
    3. group Id
      BG002
      value
      16
    4. group Id
      BG003
      value
      17
    5. group Id
      BG004
      value
      125
    units
    Participants
groups
  1. description
    Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
    id
    BG000
    title
    Cohort A
  2. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    BG001
    title
    Cohort B
  3. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    BG002
    title
    Cohort C
  4. description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    BG003
    title
    Cohort D
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.69
          value
          53.2
        2. group Id
          BG001
          spread
          11.05
          value
          55.1
        3. group Id
          BG002
          spread
          10.40
          value
          65.6
        4. group Id
          BG003
          spread
          13.01
          value
          47.5
        5. group Id
          BG004
          spread
          14.29
          value
          54.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          53
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          72
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          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
          0
        5. group Id
          BG004
          value
          0
        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
        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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          125
        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
        title
        More than one race
      7. 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
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice