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NCT04099251 · BASELINE

Baseline characteristics

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma · Source last updated 2026-08-07

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
      526
    2. group Id
      BG001
      value
      264
    3. group Id
      BG002
      value
      790
    units
    Participants
groups
  1. description
    Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
    id
    BG000
    title
    Nivolumab
  2. description
    Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.9
          value
          59.9
        2. group Id
          BG001
          spread
          13.6
          value
          59.3
        3. group Id
          BG002
          spread
          13.8
          value
          59.7
    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
          204
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          307
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          322
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          483
        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
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          17
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          317
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          457
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          198
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          316
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          515
        2. group Id
          BG001
          value
          262
        3. group Id
          BG002
          value
          777
        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
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      526
    2. group Id
      BG001
      value
      264
    3. group Id
      BG002
      value
      790
    units
    Participants
groups
  1. description
    Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
    id
    BG000
    title
    Nivolumab
  2. description
    Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.9
          value
          59.9
        2. group Id
          BG001
          spread
          13.6
          value
          59.3
        3. group Id
          BG002
          spread
          13.8
          value
          59.7
    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
          204
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          307
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          322
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          483
        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
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          17
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          317
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          457
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          198
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          316
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          515
        2. group Id
          BG001
          value
          262
        3. group Id
          BG002
          value
          777
        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
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice