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NCT00410826 · BASELINE

Baseline characteristics

Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2013-05-10

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
      104
    2. group Id
      BG001
      value
      99
    3. group Id
      BG002
      value
      203
    units
    Participants
groups
  1. description
    Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
    id
    BG000
    title
    Arm A (Cisplatin and Radiotherapy)
  2. description
    Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
    id
    BG001
    title
    Arm B (Cisplatin, Radiotherapy, Erlotinib)
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          177
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          26
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          74
          value
          57
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          77
          value
          56
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          77
          value
          56
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          175
        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
          104
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          203
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
204 patients were randomized. However, after completing study therapy, it became apparent that one participant had metastatic disease and was therefore, ineligible for study. This participant was excluded from subsequent results presented here.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      104
    2. group Id
      BG001
      value
      99
    3. group Id
      BG002
      value
      203
    units
    Participants
groups
  1. description
    Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
    id
    BG000
    title
    Arm A (Cisplatin and Radiotherapy)
  2. description
    Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
    id
    BG001
    title
    Arm B (Cisplatin, Radiotherapy, Erlotinib)
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          177
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          26
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          74
          value
          57
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          77
          value
          56
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          77
          value
          56
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          175
        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
          104
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          203
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
204 patients were randomized. However, after completing study therapy, it became apparent that one participant had metastatic disease and was therefore, ineligible for study. This participant was excluded from subsequent results presented here.

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Preserved source evidence · Not medical advice