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NCT00293462 · BASELINE

Baseline characteristics

GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer · Source last updated 2021-07-30

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
      31
    2. group Id
      BG001
      value
      29
    3. group Id
      BG002
      value
      31
    4. group Id
      BG003
      value
      91
    units
    Participants
groups
  1. description
    Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    BG000
    title
    Arm I: GM-CSF Group (GG)
  2. description
    Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    BG001
    title
    Arm II: Salt & Soda Group (SS)
  3. description
    Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
    id
    BG002
    title
    Arm III: Salt & Soda Switched to GM-CSF (SG)
  4. description
    Total of all reporting groups
    id
    BG003
    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
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          77
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          14
        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
          spread
          13.73
          value
          53.55
        2. group Id
          BG001
          spread
          12.22
          value
          54.69
        3. group Id
          BG002
          spread
          11.29
          value
          56.26
        4. group Id
          BG003
          spread
          12.43
          value
          54.48
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          67
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          85
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          21
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          56
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        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
      31
    2. group Id
      BG001
      value
      29
    3. group Id
      BG002
      value
      31
    4. group Id
      BG003
      value
      91
    units
    Participants
groups
  1. description
    Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    BG000
    title
    Arm I: GM-CSF Group (GG)
  2. description
    Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    BG001
    title
    Arm II: Salt & Soda Group (SS)
  3. description
    Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
    id
    BG002
    title
    Arm III: Salt & Soda Switched to GM-CSF (SG)
  4. description
    Total of all reporting groups
    id
    BG003
    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
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          77
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          14
        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
          spread
          13.73
          value
          53.55
        2. group Id
          BG001
          spread
          12.22
          value
          54.69
        3. group Id
          BG002
          spread
          11.29
          value
          56.26
        4. group Id
          BG003
          spread
          12.43
          value
          54.48
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          67
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          85
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          21
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          56
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice