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NCT00984282 · BASELINE

Baseline characteristics

Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer · Source last updated 2018-09-13

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
      207
    2. group Id
      BG001
      value
      210
    3. group Id
      BG002
      value
      417
    units
    Participants
groups
  1. description
    Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
    id
    BG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.2
          value
          61.5
        2. group Id
          BG001
          spread
          11.7
          value
          62.0
        3. group Id
          BG002
          spread
          11.4
          value
          61.8
    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
          80
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          161
        title
        < 60 years
      2. measurements
        1. group Id
          BG000
          value
          127
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          256
        title
        >= 60 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          218
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          199
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          249
        title
        Europe
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          72
        title
        North America
      3. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          96
        title
        Asia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic region
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Missing
      2. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          259
        title
        0
      3. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          143
        title
        1
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        title
        2
    description
    The ECOG PS required for the study was 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), or 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 (Eastern Cooperative Oncology Group) performance status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          181
        3. group Id
          BG002
          value
          359
      title
      Lung
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          113
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          214
      title
      Lymph node
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          113
      title
      Bone
    description
    Participants could have had more than one site.
    param Type
    NUMBER
    title
    Site of target/nontarget lesions at baseline - organ class
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      207
    2. group Id
      BG001
      value
      210
    3. group Id
      BG002
      value
      417
    units
    Participants
groups
  1. description
    Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
    id
    BG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.2
          value
          61.5
        2. group Id
          BG001
          spread
          11.7
          value
          62.0
        3. group Id
          BG002
          spread
          11.4
          value
          61.8
    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
          80
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          161
        title
        < 60 years
      2. measurements
        1. group Id
          BG000
          value
          127
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          256
        title
        >= 60 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          218
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          199
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          249
        title
        Europe
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          72
        title
        North America
      3. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          96
        title
        Asia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic region
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Missing
      2. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          259
        title
        0
      3. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          143
        title
        1
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        title
        2
    description
    The ECOG PS required for the study was 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), or 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 (Eastern Cooperative Oncology Group) performance status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          181
        3. group Id
          BG002
          value
          359
      title
      Lung
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          113
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          214
      title
      Lymph node
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          113
      title
      Bone
    description
    Participants could have had more than one site.
    param Type
    NUMBER
    title
    Site of target/nontarget lesions at baseline - organ class
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice