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NCT01336634 · BASELINE

Baseline characteristics

Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer. · Source last updated 2022-04-04

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
      84
    2. group Id
      BG001
      value
      57
    3. group Id
      BG002
      value
      36
    4. group Id
      BG003
      value
      177
    units
    Participants
groups
  1. description
    Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
    id
    BG000
    title
    Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID
  2. description
    Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
    id
    BG001
    title
    Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD
  3. description
    Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
    id
    BG002
    title
    Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.51
          value
          64.8
        2. group Id
          BG001
          spread
          10.14
          value
          65.1
        3. group Id
          BG002
          spread
          11.00
          value
          67.8
        4. group Id
          BG003
          spread
          10.50
          value
          65.5
    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
          44
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          94
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          83
        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
          64
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          143
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          25
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      African American Heritage
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Native Hawaiian or other Pacific islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Black or African American
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          50
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          109
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          18
        title
        Grade 2
    description
    The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classifies participants according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). ECOG PS: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      84
    2. group Id
      BG001
      value
      57
    3. group Id
      BG002
      value
      36
    4. group Id
      BG003
      value
      177
    units
    Participants
groups
  1. description
    Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
    id
    BG000
    title
    Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID
  2. description
    Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
    id
    BG001
    title
    Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD
  3. description
    Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
    id
    BG002
    title
    Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.51
          value
          64.8
        2. group Id
          BG001
          spread
          10.14
          value
          65.1
        3. group Id
          BG002
          spread
          11.00
          value
          67.8
        4. group Id
          BG003
          spread
          10.50
          value
          65.5
    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
          44
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          94
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          83
        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
          64
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          143
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          25
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      African American Heritage
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Native Hawaiian or other Pacific islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Black or African American
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          50
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          109
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          18
        title
        Grade 2
    description
    The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classifies participants according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). ECOG PS: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants

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

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