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NCT02388906 · BASELINE

Baseline characteristics

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma · Source last updated 2025-04-24

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
      453
    2. group Id
      BG001
      value
      453
    3. group Id
      BG002
      value
      906
    units
    Participants
groups
  1. description
    Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
    id
    BG000
    title
    Nivolumab 3 mg/kg
  2. description
    Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
    id
    BG001
    title
    Ipilimumab 10 mg/kg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.34
          value
          54.4
        2. group Id
          BG001
          spread
          13.50
          value
          53.6
        3. group Id
          BG002
          spread
          13.42
          value
          54.0
    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
          195
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          379
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          258
        2. group Id
          BG001
          value
          269
        3. group Id
          BG002
          value
          527
        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
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          215
        2. group Id
          BG001
          value
          208
        3. group Id
          BG002
          value
          423
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          232
        2. group Id
          BG001
          value
          237
        3. group Id
          BG002
          value
          469
        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
          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
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          43
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          425
        2. group Id
          BG001
          value
          434
        3. group Id
          BG002
          value
          859
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All Randomized Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      453
    2. group Id
      BG001
      value
      453
    3. group Id
      BG002
      value
      906
    units
    Participants
groups
  1. description
    Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
    id
    BG000
    title
    Nivolumab 3 mg/kg
  2. description
    Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
    id
    BG001
    title
    Ipilimumab 10 mg/kg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.34
          value
          54.4
        2. group Id
          BG001
          spread
          13.50
          value
          53.6
        3. group Id
          BG002
          spread
          13.42
          value
          54.0
    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
          195
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          379
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          258
        2. group Id
          BG001
          value
          269
        3. group Id
          BG002
          value
          527
        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
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          215
        2. group Id
          BG001
          value
          208
        3. group Id
          BG002
          value
          423
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          232
        2. group Id
          BG001
          value
          237
        3. group Id
          BG002
          value
          469
        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
          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
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          43
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          425
        2. group Id
          BG001
          value
          434
        3. group Id
          BG002
          value
          859
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All Randomized Participants

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Preserved source evidence · Not medical advice