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NCT02823574 · BASELINE

Baseline characteristics

Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-05-03

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
      159
    2. group Id
      BG001
      value
      82
    3. group Id
      BG002
      value
      123
    4. group Id
      BG003
      value
      61
    5. group Id
      BG004
      value
      425
    units
    Participants
groups
  1. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    BG000
    title
    Treatment A - Platinum Refractory Subgroup
  2. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
    id
    BG001
    title
    Treatment B - Platinum Refractory Subgroup
  3. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    BG002
    title
    Treatment A - Platinum Eligible Subgroup
  4. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
    id
    BG003
    title
    Treatment B - Platinum Eligible Subgroup
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          40
        5. group Id
          BG004
          value
          301
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          124
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All Randomized Participants is the total of the 2 subgroups
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          79
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          47
        5. group Id
          BG004
          value
          346
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All Randomized Participants is the total of the 2 subgroups
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          29
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          66
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          170
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          226
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All Randomized Participants is the total of the 2 subgroups
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          120
        4. group Id
          BG003
          value
          58
        5. group Id
          BG004
          value
          394
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          18
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All Randomized Participants is the total of the 2 subgroups
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All Randomized Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      159
    2. group Id
      BG001
      value
      82
    3. group Id
      BG002
      value
      123
    4. group Id
      BG003
      value
      61
    5. group Id
      BG004
      value
      425
    units
    Participants
groups
  1. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    BG000
    title
    Treatment A - Platinum Refractory Subgroup
  2. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
    id
    BG001
    title
    Treatment B - Platinum Refractory Subgroup
  3. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    BG002
    title
    Treatment A - Platinum Eligible Subgroup
  4. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
    id
    BG003
    title
    Treatment B - Platinum Eligible Subgroup
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          40
        5. group Id
          BG004
          value
          301
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          124
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All Randomized Participants is the total of the 2 subgroups
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          79
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          47
        5. group Id
          BG004
          value
          346
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All Randomized Participants is the total of the 2 subgroups
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          29
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          66
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          170
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          226
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All Randomized Participants is the total of the 2 subgroups
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          120
        4. group Id
          BG003
          value
          58
        5. group Id
          BG004
          value
          394
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          18
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All Randomized Participants is the total of the 2 subgroups
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All Randomized Participants

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

Preserved source evidence · Not medical advice