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NCT02811861 · BASELINE

Baseline characteristics

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma · Source last updated 2026-02-23

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
      357
    2. group Id
      BG001
      value
      355
    3. group Id
      BG002
      value
      357
    4. group Id
      BG003
      value
      1069
    units
    Participants
groups
  1. description
    Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
    id
    BG000
    title
    Lenvatinib 18 mg Plus Everolimus 5 mg
  2. description
    Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
    id
    BG001
    title
    Lenvatinib 20 mg Plus Pembrolizumab 200 mg
  3. description
    Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
    id
    BG002
    title
    Sunitinib 50 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.86
          value
          61.9
        2. group Id
          BG001
          spread
          10.23
          value
          62.3
        3. group Id
          BG002
          spread
          9.96
          value
          60.8
        4. group Id
          BG003
          spread
          10.36
          value
          61.7
    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
          91
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          82
        4. group Id
          BG003
          value
          273
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          266
        2. group Id
          BG001
          value
          255
        3. group Id
          BG002
          value
          275
        4. group Id
          BG003
          value
          796
        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
          23
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          328
        2. group Id
          BG001
          value
          339
        3. group Id
          BG002
          value
          334
        4. group Id
          BG003
          value
          1001
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          254
        2. group Id
          BG001
          value
          263
        3. group Id
          BG002
          value
          270
        4. group Id
          BG003
          value
          787
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          225
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaskan Native
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          18
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          31
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The full analysis set (FAS) included all randomized participants regardless of the treatment actually received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      357
    2. group Id
      BG001
      value
      355
    3. group Id
      BG002
      value
      357
    4. group Id
      BG003
      value
      1069
    units
    Participants
groups
  1. description
    Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
    id
    BG000
    title
    Lenvatinib 18 mg Plus Everolimus 5 mg
  2. description
    Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
    id
    BG001
    title
    Lenvatinib 20 mg Plus Pembrolizumab 200 mg
  3. description
    Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
    id
    BG002
    title
    Sunitinib 50 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.86
          value
          61.9
        2. group Id
          BG001
          spread
          10.23
          value
          62.3
        3. group Id
          BG002
          spread
          9.96
          value
          60.8
        4. group Id
          BG003
          spread
          10.36
          value
          61.7
    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
          91
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          82
        4. group Id
          BG003
          value
          273
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          266
        2. group Id
          BG001
          value
          255
        3. group Id
          BG002
          value
          275
        4. group Id
          BG003
          value
          796
        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
          23
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          328
        2. group Id
          BG001
          value
          339
        3. group Id
          BG002
          value
          334
        4. group Id
          BG003
          value
          1001
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          254
        2. group Id
          BG001
          value
          263
        3. group Id
          BG002
          value
          270
        4. group Id
          BG003
          value
          787
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          225
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaskan Native
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          18
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          31
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The full analysis set (FAS) included all randomized participants regardless of the treatment actually received.

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

Preserved source evidence · Not medical advice