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NCT01667419 · BASELINE

Baseline characteristics

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma · Source last updated 2019-07-23

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
      157
    2. group Id
      BG001
      value
      157
    3. group Id
      BG002
      value
      93
    4. group Id
      BG003
      value
      91
    5. group Id
      BG004
      value
      498
    units
    Participants
groups
  1. description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    BG000
    title
    Cohort 1 Vemurafenib
  2. description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    BG001
    title
    Cohort 1 Placebo
  3. description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    BG002
    title
    Cohort 2 Vemurafenib
  4. description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    BG003
    title
    Cohort 2 Placebo
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.4
          value
          50.7
        2. group Id
          BG001
          spread
          12.7
          value
          49.6
        3. group Id
          BG002
          spread
          14.1
          value
          51.6
        4. group Id
          BG003
          spread
          12.9
          value
          49.1
        5. group Id
          BG004
          spread
          12.9
          value
          50.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          215
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          59
        5. group Id
          BG004
          value
          283
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          25
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          80
        5. group Id
          BG004
          value
          445
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          28
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          84
        4. group Id
          BG003
          value
          81
        5. group Id
          BG004
          value
          465
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
      title
      Other
    3. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Multiple
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          26
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      157
    2. group Id
      BG001
      value
      157
    3. group Id
      BG002
      value
      93
    4. group Id
      BG003
      value
      91
    5. group Id
      BG004
      value
      498
    units
    Participants
groups
  1. description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    BG000
    title
    Cohort 1 Vemurafenib
  2. description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    BG001
    title
    Cohort 1 Placebo
  3. description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    BG002
    title
    Cohort 2 Vemurafenib
  4. description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    BG003
    title
    Cohort 2 Placebo
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.4
          value
          50.7
        2. group Id
          BG001
          spread
          12.7
          value
          49.6
        3. group Id
          BG002
          spread
          14.1
          value
          51.6
        4. group Id
          BG003
          spread
          12.9
          value
          49.1
        5. group Id
          BG004
          spread
          12.9
          value
          50.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          215
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          59
        5. group Id
          BG004
          value
          283
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          25
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          80
        5. group Id
          BG004
          value
          445
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          28
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          84
        4. group Id
          BG003
          value
          81
        5. group Id
          BG004
          value
          465
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
      title
      Other
    3. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Multiple
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          26
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.

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

Preserved source evidence · Not medical advice