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NCT02105636 · BASELINE

Baseline characteristics

Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) · Source last updated 2022-10-05

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
      240
    2. group Id
      BG001
      value
      121
    3. group Id
      BG002
      value
      361
    units
    Participants
groups
  1. description
    Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
    id
    BG000
    title
    Nivolumab 3mg/kg
  2. description
    Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
    id
    BG001
    title
    Investigators Choice
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.15
          value
          59.0
        2. group Id
          BG001
          spread
          11.00
          value
          59.4
        3. group Id
          BG002
          spread
          10.43
          value
          59.1
    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
          172
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          248
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          95
      title
      >=65 and <75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      title
      >=75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          61
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          300
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          300
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          43
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
      title
      Hispanic/Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          192
      title
      Not Hispanic/Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          156
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      240
    2. group Id
      BG001
      value
      121
    3. group Id
      BG002
      value
      361
    units
    Participants
groups
  1. description
    Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
    id
    BG000
    title
    Nivolumab 3mg/kg
  2. description
    Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
    id
    BG001
    title
    Investigators Choice
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.15
          value
          59.0
        2. group Id
          BG001
          spread
          11.00
          value
          59.4
        3. group Id
          BG002
          spread
          10.43
          value
          59.1
    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
          172
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          248
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          95
      title
      >=65 and <75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      title
      >=75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          61
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          300
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          300
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          43
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
      title
      Hispanic/Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          192
      title
      Not Hispanic/Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          156
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice