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NCT00100789 · BASELINE

Baseline characteristics

S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer · Source last updated 2012-10-01

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
      63
    units
    Participants
groups
  1. description
    Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
    id
    BG000
    title
    Gemcitabine and Paclitaxel
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40.7
          upper Limit
          82.9
          value
          63.1
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          56
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          50
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Lip/Oral Cavity
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Nasopharynx
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Oropharynx
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Salivary glands
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Hypopharynx
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Larynx
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Paranasal Sinuses
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Other/Unknown
    param Type
    NUMBER
    title
    Primary Site
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Newly Diagnosed
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Persistent
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      Recurrent
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Not Reported
    param Type
    NUMBER
    title
    Disease Status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
      title
      1
    description
    Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
    param Type
    NUMBER
    title
    Performance Status
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      63
    units
    Participants
groups
  1. description
    Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
    id
    BG000
    title
    Gemcitabine and Paclitaxel
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40.7
          upper Limit
          82.9
          value
          63.1
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          56
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          50
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Lip/Oral Cavity
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Nasopharynx
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Oropharynx
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Salivary glands
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Hypopharynx
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Larynx
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Paranasal Sinuses
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Other/Unknown
    param Type
    NUMBER
    title
    Primary Site
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Newly Diagnosed
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Persistent
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      Recurrent
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Not Reported
    param Type
    NUMBER
    title
    Disease Status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
      title
      1
    description
    Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
    param Type
    NUMBER
    title
    Performance Status
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice