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NCT01256385 · BASELINE

Baseline characteristics

Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy · Source last updated 2017-03-27

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
      40
    2. group Id
      BG001
      value
      40
    3. group Id
      BG002
      value
      80
    units
    Participants
groups
  1. description
    Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm A (Cetuximab and Temsirolimus)
  2. description
    Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
    id
    BG001
    title
    Arm B (Temsirolimus)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          86
          value
          63
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          81
          value
          63
        3. group Id
          BG002
          lower Limit
          39
          upper Limit
          86
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          69
        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
          40
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          80
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Three patients from each treatment arm did not start treatment and are considered non-evaluable.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      40
    2. group Id
      BG001
      value
      40
    3. group Id
      BG002
      value
      80
    units
    Participants
groups
  1. description
    Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm A (Cetuximab and Temsirolimus)
  2. description
    Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
    id
    BG001
    title
    Arm B (Temsirolimus)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          86
          value
          63
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          81
          value
          63
        3. group Id
          BG002
          lower Limit
          39
          upper Limit
          86
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          69
        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
          40
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          80
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Three patients from each treatment arm did not start treatment and are considered non-evaluable.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice