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NCT04195750 · BASELINE

Baseline characteristics

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) · Source last updated 2026-05-14

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
      374
    2. group Id
      BG001
      value
      372
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      755
    units
    Participants
groups
  1. description
    Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.
    id
    BG000
    title
    Belzutifan
  2. description
    Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.
    id
    BG001
    title
    Everolimus
  3. description
    Non-Randomized participants enrolled into the Safety Run-in received up to 120 mg of belzutifan QD.
    id
    BG002
    title
    Safety Run-In
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.2
          value
          61.6
        2. group Id
          BG001
          spread
          9.7
          value
          63.1
        3. group Id
          BG002
          spread
          6.6
          value
          70.0
        4. group Id
          BG003
          spread
          10.0
          value
          62.4
    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
          77
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          169
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          284
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          586
        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
          41
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          78
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          303
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          612
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          65
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          99
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          291
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          588
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          17
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          37
        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
          81
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          171
        title
        Favorable
      2. measurements
        1. group Id
          BG000
          value
          248
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          493
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          91
        title
        Poor
    description
    Stratification factor per case report form based on the following risk factors: baseline Karnofsky Performance Status \<80%; interval between initial diagnosis of renal cell carcinoma to start of first-line systemic treatment for advanced disease \<1year; baseline hemoglobin \<lower limit of normal (LLN); baseline platelet count \>upper limit of normal (ULN); baseline corrected serum calcium \>ULN; and baseline neutrophil \>ULN. The category was determined by totaling the risk factors per participant: favorable (0 factors); intermediate (1-2 factors); and poor (≥3 factors).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Category
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          190
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          379
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          182
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          376
        title
        2-3
    description
    Stratification factor per case report form, the number of prior VEGF/VEGF-Receptor targeted therapies that they received to treat their advanced Renal Cell Carcinoma (RCC): 1 versus 2-3.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Vascular Endothelial Growth Factor (VEGF)/VEGF-Receptor Targeted Therapies
    unit Of Measure
    Participants
population Description
Per protocol, the 9 participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      374
    2. group Id
      BG001
      value
      372
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      755
    units
    Participants
groups
  1. description
    Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.
    id
    BG000
    title
    Belzutifan
  2. description
    Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.
    id
    BG001
    title
    Everolimus
  3. description
    Non-Randomized participants enrolled into the Safety Run-in received up to 120 mg of belzutifan QD.
    id
    BG002
    title
    Safety Run-In
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.2
          value
          61.6
        2. group Id
          BG001
          spread
          9.7
          value
          63.1
        3. group Id
          BG002
          spread
          6.6
          value
          70.0
        4. group Id
          BG003
          spread
          10.0
          value
          62.4
    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
          77
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          169
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          284
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          586
        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
          41
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          78
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          303
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          612
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          65
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          99
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          291
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          588
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          17
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          37
        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
          81
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          171
        title
        Favorable
      2. measurements
        1. group Id
          BG000
          value
          248
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          493
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          91
        title
        Poor
    description
    Stratification factor per case report form based on the following risk factors: baseline Karnofsky Performance Status \<80%; interval between initial diagnosis of renal cell carcinoma to start of first-line systemic treatment for advanced disease \<1year; baseline hemoglobin \<lower limit of normal (LLN); baseline platelet count \>upper limit of normal (ULN); baseline corrected serum calcium \>ULN; and baseline neutrophil \>ULN. The category was determined by totaling the risk factors per participant: favorable (0 factors); intermediate (1-2 factors); and poor (≥3 factors).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Category
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          190
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          379
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          182
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          376
        title
        2-3
    description
    Stratification factor per case report form, the number of prior VEGF/VEGF-Receptor targeted therapies that they received to treat their advanced Renal Cell Carcinoma (RCC): 1 versus 2-3.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Vascular Endothelial Growth Factor (VEGF)/VEGF-Receptor Targeted Therapies
    unit Of Measure
    Participants
population Description
Per protocol, the 9 participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures.

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Preserved source evidence · Not medical advice