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NCT02034110 · BASELINE

Baseline characteristics

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers · Source last updated 2023-08-21

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
      36
    2. group Id
      BG001
      value
      43
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      13
    5. group Id
      BG004
      value
      45
    6. group Id
      BG005
      value
      3
    7. group Id
      BG006
      value
      55
    8. group Id
      BG007
      value
      10
    9. group Id
      BG008
      value
      206
    units
    Participants
groups
  1. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG000
    title
    Anaplastic Thyroid Cancer (ATC)
  2. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG001
    title
    Biliary Tract Cancer (BTC)
  3. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG002
    title
    Gastrointestinal Stromal Tumor (GIST)
  4. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG003
    title
    Low Grade (WHO G1/G2) Glioma (LGG)
  5. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG004
    title
    High Grade (WHO G3/G4) Glioma (HGG)
  6. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG005
    title
    Adenocarcinoma of the Small Intestine (ASI)
  7. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG006
    title
    Hairy Cell Leukemia (HCL)
  8. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG007
    title
    Multiple Myeloma (MM)
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.53
          value
          69.6
        2. group Id
          BG001
          spread
          11.88
          value
          57.0
        3. comment
          Only one participant analyzed
          group Id
          BG002
          spread
          NA
          value
          77.0
        4. group Id
          BG003
          spread
          11.51
          value
          33.1
        5. group Id
          BG004
          spread
          14.70
          value
          41.9
        6. group Id
          BG005
          spread
          3.21
          value
          58.3
        7. group Id
          BG006
          spread
          10.77
          value
          64.8
        8. group Id
          BG007
          spread
          6.89
          value
          66.9
        9. group Id
          BG008
          spread
          16.40
          value
          57.1
    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
          20
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          22
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          90
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          23
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          47
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          116
        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
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          4
      title
      African American/African Heritage
    2. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      American Indian or Alaska Native
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        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
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      Asian - Central/South Asian Heritage
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          17
      title
      Asian - East Asian Heritage
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          7
      title
      Asian - Japanese Heritage
    6. 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
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
      title
      Asian - South East Asian Heritage
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          5
      title
      White - Arabic/North African Heritage
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          32
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          48
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          157
      title
      White - White/Caucasian/European heritage
    9. 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
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          10
      title
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          25
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          72
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          27
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          118
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          16
        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
      36
    2. group Id
      BG001
      value
      43
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      13
    5. group Id
      BG004
      value
      45
    6. group Id
      BG005
      value
      3
    7. group Id
      BG006
      value
      55
    8. group Id
      BG007
      value
      10
    9. group Id
      BG008
      value
      206
    units
    Participants
groups
  1. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG000
    title
    Anaplastic Thyroid Cancer (ATC)
  2. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG001
    title
    Biliary Tract Cancer (BTC)
  3. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG002
    title
    Gastrointestinal Stromal Tumor (GIST)
  4. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG003
    title
    Low Grade (WHO G1/G2) Glioma (LGG)
  5. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG004
    title
    High Grade (WHO G3/G4) Glioma (HGG)
  6. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG005
    title
    Adenocarcinoma of the Small Intestine (ASI)
  7. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG006
    title
    Hairy Cell Leukemia (HCL)
  8. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    BG007
    title
    Multiple Myeloma (MM)
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.53
          value
          69.6
        2. group Id
          BG001
          spread
          11.88
          value
          57.0
        3. comment
          Only one participant analyzed
          group Id
          BG002
          spread
          NA
          value
          77.0
        4. group Id
          BG003
          spread
          11.51
          value
          33.1
        5. group Id
          BG004
          spread
          14.70
          value
          41.9
        6. group Id
          BG005
          spread
          3.21
          value
          58.3
        7. group Id
          BG006
          spread
          10.77
          value
          64.8
        8. group Id
          BG007
          spread
          6.89
          value
          66.9
        9. group Id
          BG008
          spread
          16.40
          value
          57.1
    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
          20
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          22
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          90
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          23
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          47
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          116
        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
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          4
      title
      African American/African Heritage
    2. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      American Indian or Alaska Native
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        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
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      Asian - Central/South Asian Heritage
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          17
      title
      Asian - East Asian Heritage
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          7
      title
      Asian - Japanese Heritage
    6. 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
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
      title
      Asian - South East Asian Heritage
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          5
      title
      White - Arabic/North African Heritage
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          32
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          48
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          157
      title
      White - White/Caucasian/European heritage
    9. 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
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          10
      title
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          25
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          72
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          27
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          118
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          16
        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

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