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NCT00101582 · BASELINE

Baseline characteristics

Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer · Source last updated 2016-09-27

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
      94
    2. group Id
      BG001
      value
      94
    3. group Id
      BG002
      value
      188
    units
    Participants
groups
  1. description
    Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
    id
    BG000
    title
    Placebo
  2. description
    Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
    id
    BG001
    title
    Palifermin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.3
          value
          55.4
        2. group Id
          BG001
          spread
          8.6
          value
          55.5
        3. group Id
          BG002
          spread
          8.5
          value
          55.5
    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
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          159
        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
          90
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          173
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Hispanic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian/ Alaska Native
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.7
          value
          71.8
        2. group Id
          BG001
          spread
          16.4
          value
          74.5
        3. group Id
          BG002
          spread
          16.1
          value
          73.2
    description
    Data available for 91 and 94 participants in each treatment group respectively.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilograms
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          55
      title
      Stage III
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          114
      title
      Stage IV A
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
      title
      Stage IV B
    description
    American Joint Committee on Cancer staging system.
    param Type
    NUMBER
    title
    Disease Stage
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
      title
      Oral Cavity
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          106
      title
      Oropharynx
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Nasopharynx
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          25
      title
      Larynx
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          36
      title
      Hypopharynx
    param Type
    NUMBER
    title
    Tumor Site
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      94
    2. group Id
      BG001
      value
      94
    3. group Id
      BG002
      value
      188
    units
    Participants
groups
  1. description
    Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
    id
    BG000
    title
    Placebo
  2. description
    Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
    id
    BG001
    title
    Palifermin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.3
          value
          55.4
        2. group Id
          BG001
          spread
          8.6
          value
          55.5
        3. group Id
          BG002
          spread
          8.5
          value
          55.5
    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
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          159
        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
          90
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          173
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Hispanic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian/ Alaska Native
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.7
          value
          71.8
        2. group Id
          BG001
          spread
          16.4
          value
          74.5
        3. group Id
          BG002
          spread
          16.1
          value
          73.2
    description
    Data available for 91 and 94 participants in each treatment group respectively.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilograms
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          55
      title
      Stage III
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          114
      title
      Stage IV A
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
      title
      Stage IV B
    description
    American Joint Committee on Cancer staging system.
    param Type
    NUMBER
    title
    Disease Stage
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
      title
      Oral Cavity
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          106
      title
      Oropharynx
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Nasopharynx
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          25
      title
      Larynx
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          36
      title
      Hypopharynx
    param Type
    NUMBER
    title
    Tumor Site
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice