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NCT01245062 · BASELINE

Baseline characteristics

GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma · Source last updated 2018-04-05

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
      214
    2. group Id
      BG001
      value
      108
    3. group Id
      BG002
      value
      322
    units
    Participants
groups
  1. description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
    id
    BG000
    title
    Trametinib
  2. description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.97
          value
          54.3
        2. group Id
          BG001
          spread
          13.56
          value
          52.8
        3. group Id
          BG002
          spread
          13.17
          value
          53.8
    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
          94
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          149
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          173
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        White - Arabic/North African Heritage
      2. measurements
        1. group Id
          BG000
          value
          212
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          319
        title
        White - White/Caucasian/European Heritage
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        White - Mixed Race
      title
      Race/Ethnicity, Customized
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      214
    2. group Id
      BG001
      value
      108
    3. group Id
      BG002
      value
      322
    units
    Participants
groups
  1. description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
    id
    BG000
    title
    Trametinib
  2. description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.97
          value
          54.3
        2. group Id
          BG001
          spread
          13.56
          value
          52.8
        3. group Id
          BG002
          spread
          13.17
          value
          53.8
    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
          94
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          149
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          173
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        White - Arabic/North African Heritage
      2. measurements
        1. group Id
          BG000
          value
          212
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          319
        title
        White - White/Caucasian/European Heritage
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        White - Mixed Race
      title
      Race/Ethnicity, Customized
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice