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NCT01865747 · BASELINE

Baseline characteristics

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma · Source last updated 2021-04-27

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
      330
    2. group Id
      BG001
      value
      328
    3. group Id
      BG002
      value
      658
    units
    Participants
groups
  1. description
    Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets
    id
    BG000
    title
    Cabozantinib (XL184)
  2. description
    Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
    id
    BG001
    title
    Everolimus (Afinitor)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          198
        3. group Id
          BG002
          value
          394
      title
      <65
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          201
      title
      65 to <75
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          62
      title
      75 to <85
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      =>85
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          253
        2. group Id
          BG001
          value
          241
        3. group Id
          BG002
          value
          494
      title
      Male
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          163
      title
      Female
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          278
        2. group Id
          BG001
          value
          273
        3. group Id
          BG002
          value
          551
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          70
        title
        Unknown or Not Reported
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          47
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          263
        3. group Id
          BG002
          value
          532
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          70
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          167
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          320
      title
      Europe
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          240
      title
      North America
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          86
      title
      Asia Pacific
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Latin America
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          235
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          464
      title
      Prior VEGFR-TKI = 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          194
      title
      Prior VEGFR-TKI ≥ 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          300
      title
      MSKCC risk factors = 0
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          274
      title
      MSKCC risk factors = 1
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          84
      title
      MSKCC risk factors = 2 or 3
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          202
      title
      Prior VEGFR-TKI = 1, MSKCC risk factors = 0
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          210
      title
      Prior VEGFR-TKI = 1, MSKCC risk factors = 1
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          52
      title
      Prior VEGFR-TKI = 1, MSKCC risk factors = 2 or 3
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          98
      title
      Prior VEGFR-TKI ≥ 2, MSKCC risk factors =0
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          64
      title
      Prior VEGFR-TKI ≥ 2, MSKCC risk factors = 1
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          32
      title
      Prior VEGFR-TKI ≥ 2, MSKCC risk factors = 2 or 3
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratification Factors per CRF
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          173
      title
      100 (normal activity)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          127
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          269
      title
      90 (normal activity, minor signs and symptoms)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          165
      title
      80 (normal w/effort, minor signs/symptoms)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          51
      title
      70 (unable to work, cares for self)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky performance status (KPS)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
      title
      0 adverse factors (favorable risk)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          210
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          424
      title
      1-2 adverse factors (intermediate risk)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          106
      title
      3-6 adverse factors (poor risk)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Heng Prognostic Criteria
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      330
    2. group Id
      BG001
      value
      328
    3. group Id
      BG002
      value
      658
    units
    Participants
groups
  1. description
    Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets
    id
    BG000
    title
    Cabozantinib (XL184)
  2. description
    Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
    id
    BG001
    title
    Everolimus (Afinitor)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          198
        3. group Id
          BG002
          value
          394
      title
      <65
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          201
      title
      65 to <75
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          62
      title
      75 to <85
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      =>85
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          253
        2. group Id
          BG001
          value
          241
        3. group Id
          BG002
          value
          494
      title
      Male
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          163
      title
      Female
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          278
        2. group Id
          BG001
          value
          273
        3. group Id
          BG002
          value
          551
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          70
        title
        Unknown or Not Reported
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          47
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          263
        3. group Id
          BG002
          value
          532
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          70
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          167
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          320
      title
      Europe
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          240
      title
      North America
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          86
      title
      Asia Pacific
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Latin America
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          235
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          464
      title
      Prior VEGFR-TKI = 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          194
      title
      Prior VEGFR-TKI ≥ 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          300
      title
      MSKCC risk factors = 0
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          274
      title
      MSKCC risk factors = 1
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          84
      title
      MSKCC risk factors = 2 or 3
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          202
      title
      Prior VEGFR-TKI = 1, MSKCC risk factors = 0
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          210
      title
      Prior VEGFR-TKI = 1, MSKCC risk factors = 1
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          52
      title
      Prior VEGFR-TKI = 1, MSKCC risk factors = 2 or 3
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          98
      title
      Prior VEGFR-TKI ≥ 2, MSKCC risk factors =0
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          64
      title
      Prior VEGFR-TKI ≥ 2, MSKCC risk factors = 1
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          32
      title
      Prior VEGFR-TKI ≥ 2, MSKCC risk factors = 2 or 3
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratification Factors per CRF
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          173
      title
      100 (normal activity)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          127
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          269
      title
      90 (normal activity, minor signs and symptoms)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          165
      title
      80 (normal w/effort, minor signs/symptoms)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          51
      title
      70 (unable to work, cares for self)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky performance status (KPS)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
      title
      0 adverse factors (favorable risk)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          210
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          424
      title
      1-2 adverse factors (intermediate risk)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          106
      title
      3-6 adverse factors (poor risk)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Heng Prognostic Criteria
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice