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NCT02741570 · BASELINE

Baseline characteristics

Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-09-21

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
      472
    2. group Id
      BG001
      value
      475
    3. group Id
      BG002
      value
      947
    units
    Participants
groups
  1. description
    Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
    id
    BG000
    title
    Nivolumab + Ipilimumab
  2. description
    Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
    id
    BG001
    title
    EXTREME Regimen
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.7
          value
          60.4
        2. group Id
          BG001
          spread
          9.5
          value
          60.9
        3. group Id
          BG002
          spread
          9.6
          value
          60.6
    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
          310
        2. group Id
          BG001
          value
          295
        3. group Id
          BG002
          value
          605
        title
        < 65
      2. measurements
        1. group Id
          BG000
          value
          134
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          285
        title
        >= 65 AND < 75
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          54
        title
        >= 75 AND < 85
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        >= 85
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          170
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          380
        2. group Id
          BG001
          value
          397
        3. group Id
          BG002
          value
          777
        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
          40
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          406
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          225
        3. group Id
          BG002
          value
          458
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          113
        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
          15
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          379
        2. group Id
          BG001
          value
          401
        3. group Id
          BG002
          value
          780
        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
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        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
      472
    2. group Id
      BG001
      value
      475
    3. group Id
      BG002
      value
      947
    units
    Participants
groups
  1. description
    Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
    id
    BG000
    title
    Nivolumab + Ipilimumab
  2. description
    Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
    id
    BG001
    title
    EXTREME Regimen
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.7
          value
          60.4
        2. group Id
          BG001
          spread
          9.5
          value
          60.9
        3. group Id
          BG002
          spread
          9.6
          value
          60.6
    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
          310
        2. group Id
          BG001
          value
          295
        3. group Id
          BG002
          value
          605
        title
        < 65
      2. measurements
        1. group Id
          BG000
          value
          134
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          285
        title
        >= 65 AND < 75
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          54
        title
        >= 75 AND < 85
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        >= 85
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          170
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          380
        2. group Id
          BG001
          value
          397
        3. group Id
          BG002
          value
          777
        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
          40
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          406
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          225
        3. group Id
          BG002
          value
          458
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          113
        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
          15
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          379
        2. group Id
          BG001
          value
          401
        3. group Id
          BG002
          value
          780
        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
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        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