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NCT01524978 · BASELINE

Baseline characteristics

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers · Source last updated 2017-11-20

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
      62
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      10
    4. group Id
      BG003
      value
      27
    5. group Id
      BG004
      value
      9
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      26
    8. group Id
      BG007
      value
      12
    9. group Id
      BG008
      value
      12
    10. group Id
      BG009
      value
      9
    11. group Id
      BG010
      value
      28
    12. group Id
      BG011
      value
      208
    units
    Participants
groups
  1. description
    Participants with NSCLC were treated with vemurafenib monotherapy.
    id
    BG000
    title
    Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
  2. description
    Participants with ovarian cancer were treated with vemurafenib monotherapy.
    id
    BG001
    title
    Cohort 2: Ovarian Cancer - Vemurafenib
  3. description
    Participants with colorectal cancer were treated with vemurafenib monotherapy.
    id
    BG002
    title
    Cohort 3a: Colorectal Cancer - Vemurafenib
  4. description
    Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
    id
    BG003
    title
    Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
  5. description
    Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
    id
    BG004
    title
    Cohort 4: Cholangiocarcinoma - Vemurafenib
  6. description
    Participants with multiple myeloma were treated with vemurafenib monotherapy.
    id
    BG005
    title
    Cohort 6: Multiple Myeloma - Vemurafenib
  7. description
    Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
    id
    BG006
    title
    Cohort 7a: ECD/LCH - Vemurafenib
  8. description
    Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
    id
    BG007
    title
    Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
  9. description
    Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
    id
    BG008
    title
    Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
  10. description
    Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
    id
    BG009
    title
    Cohort 7d: Early Stage Astrocytoma - Vemurafenib
  11. description
    Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
    id
    BG010
    title
    Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
  12. description
    Total of all reporting groups
    id
    BG011
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.2
          value
          65.4
        2. group Id
          BG001
          spread
          5.3
          value
          45.8
        3. group Id
          BG002
          spread
          5.4
          value
          57.3
        4. group Id
          BG003
          spread
          8.8
          value
          64.3
        5. group Id
          BG004
          spread
          9.7
          value
          53.2
        6. group Id
          BG005
          spread
          4.3
          value
          62.1
        7. group Id
          BG006
          spread
          13.3
          value
          60.8
        8. group Id
          BG007
          spread
          9.2
          value
          66.8
        9. group Id
          BG008
          spread
          12.2
          value
          41.6
        10. group Id
          BG009
          spread
          20.7
          value
          34.3
        11. group Id
          BG010
          spread
          17.5
          value
          53.7
        12. group Id
          BG011
          spread
          14.5
          value
          59.0
    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
          27
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          15
        12. group Id
          BG011
          value
          111
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          13
        12. group Id
          BG011
          value
          97
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      62
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      10
    4. group Id
      BG003
      value
      27
    5. group Id
      BG004
      value
      9
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      26
    8. group Id
      BG007
      value
      12
    9. group Id
      BG008
      value
      12
    10. group Id
      BG009
      value
      9
    11. group Id
      BG010
      value
      28
    12. group Id
      BG011
      value
      208
    units
    Participants
groups
  1. description
    Participants with NSCLC were treated with vemurafenib monotherapy.
    id
    BG000
    title
    Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
  2. description
    Participants with ovarian cancer were treated with vemurafenib monotherapy.
    id
    BG001
    title
    Cohort 2: Ovarian Cancer - Vemurafenib
  3. description
    Participants with colorectal cancer were treated with vemurafenib monotherapy.
    id
    BG002
    title
    Cohort 3a: Colorectal Cancer - Vemurafenib
  4. description
    Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
    id
    BG003
    title
    Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
  5. description
    Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
    id
    BG004
    title
    Cohort 4: Cholangiocarcinoma - Vemurafenib
  6. description
    Participants with multiple myeloma were treated with vemurafenib monotherapy.
    id
    BG005
    title
    Cohort 6: Multiple Myeloma - Vemurafenib
  7. description
    Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
    id
    BG006
    title
    Cohort 7a: ECD/LCH - Vemurafenib
  8. description
    Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
    id
    BG007
    title
    Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
  9. description
    Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
    id
    BG008
    title
    Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
  10. description
    Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
    id
    BG009
    title
    Cohort 7d: Early Stage Astrocytoma - Vemurafenib
  11. description
    Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
    id
    BG010
    title
    Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
  12. description
    Total of all reporting groups
    id
    BG011
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.2
          value
          65.4
        2. group Id
          BG001
          spread
          5.3
          value
          45.8
        3. group Id
          BG002
          spread
          5.4
          value
          57.3
        4. group Id
          BG003
          spread
          8.8
          value
          64.3
        5. group Id
          BG004
          spread
          9.7
          value
          53.2
        6. group Id
          BG005
          spread
          4.3
          value
          62.1
        7. group Id
          BG006
          spread
          13.3
          value
          60.8
        8. group Id
          BG007
          spread
          9.2
          value
          66.8
        9. group Id
          BG008
          spread
          12.2
          value
          41.6
        10. group Id
          BG009
          spread
          20.7
          value
          34.3
        11. group Id
          BG010
          spread
          17.5
          value
          53.7
        12. group Id
          BG011
          spread
          14.5
          value
          59.0
    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
          27
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          15
        12. group Id
          BG011
          value
          111
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          13
        12. group Id
          BG011
          value
          97
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all participants enrolled in the study irrespective of whether they had received study medication or not.

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Preserved source evidence · Not medical advice