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NCT01597908 · BASELINE

Baseline characteristics

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma · Source last updated 2021-02-24

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
      352
    2. group Id
      BG001
      value
      352
    3. group Id
      BG002
      value
      704
    units
    Participants
groups
  1. description
    Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    BG000
    title
    Dabrafenib Plus Trametinib
  2. description
    Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    BG001
    title
    Vemurafenib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.83
          value
          54.1
        2. group Id
          BG001
          spread
          14.06
          value
          54.3
        3. group Id
          BG002
          spread
          13.94
          value
          54.2
    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
          144
        2. group Id
          BG001
          value
          172
        3. group Id
          BG002
          value
          316
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          388
        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
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      Asian - East Asian Heritage
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      White - Arabic/North African Heritage
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          339
        2. group Id
          BG001
          value
          339
        3. group Id
          BG002
          value
          678
      title
      White - White/Caucasian/European Heritage
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      White - Mixed Race
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Mixed Race
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      African American/African Heritage
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaskan Native
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      352
    2. group Id
      BG001
      value
      352
    3. group Id
      BG002
      value
      704
    units
    Participants
groups
  1. description
    Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    BG000
    title
    Dabrafenib Plus Trametinib
  2. description
    Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    BG001
    title
    Vemurafenib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.83
          value
          54.1
        2. group Id
          BG001
          spread
          14.06
          value
          54.3
        3. group Id
          BG002
          spread
          13.94
          value
          54.2
    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
          144
        2. group Id
          BG001
          value
          172
        3. group Id
          BG002
          value
          316
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          388
        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
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      Asian - East Asian Heritage
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      White - Arabic/North African Heritage
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          339
        2. group Id
          BG001
          value
          339
        3. group Id
          BG002
          value
          678
      title
      White - White/Caucasian/European Heritage
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      White - Mixed Race
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Mixed Race
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      African American/African Heritage
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaskan Native
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice