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NCT02684006 · BASELINE

Baseline characteristics

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) · Source last updated 2025-07-30

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
      442
    2. group Id
      BG001
      value
      444
    3. group Id
      BG002
      value
      886
    units
    Participants
groups
  1. description
    Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was of 42 days.
    id
    BG000
    title
    Avelumab + Axitinib
  2. description
    Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
    id
    BG001
    title
    Sunitinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.95
          value
          60.86
        2. group Id
          BG001
          spread
          10.28
          value
          60.66
        3. group Id
          BG002
          spread
          10.11
          value
          60.76
    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
          126
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          226
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          316
        2. group Id
          BG001
          value
          344
        3. group Id
          BG002
          value
          660
        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
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          388
        2. group Id
          BG001
          value
          377
        3. group Id
          BG002
          value
          765
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          84
        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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          133
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          332
        2. group Id
          BG001
          value
          334
        3. group Id
          BG002
          value
          666
        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
          26
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          58
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      442
    2. group Id
      BG001
      value
      444
    3. group Id
      BG002
      value
      886
    units
    Participants
groups
  1. description
    Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was of 42 days.
    id
    BG000
    title
    Avelumab + Axitinib
  2. description
    Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
    id
    BG001
    title
    Sunitinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.95
          value
          60.86
        2. group Id
          BG001
          spread
          10.28
          value
          60.66
        3. group Id
          BG002
          spread
          10.11
          value
          60.76
    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
          126
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          226
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          316
        2. group Id
          BG001
          value
          344
        3. group Id
          BG002
          value
          660
        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
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          388
        2. group Id
          BG001
          value
          377
        3. group Id
          BG002
          value
          765
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          84
        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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          133
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          332
        2. group Id
          BG001
          value
          334
        3. group Id
          BG002
          value
          666
        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
          26
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          58
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all randomized participants.

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Preserved source evidence · Not medical advice