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NCT01156142 · BASELINE

Baseline characteristics

Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy · Source last updated 2017-08-09

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
      69
    2. group Id
      BG001
      value
      71
    3. group Id
      BG002
      value
      140
    units
    Participants
groups
  1. description
    Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
    id
    BG000
    title
    Arm I (Doxepin-Placebo)
  2. description
    Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
    id
    BG001
    title
    Arm II (Placebo-Doxepin)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          39.0
          upper Limit
          93.0
          value
          62
        2. group Id
          BG001
          lower Limit
          37.0
          upper Limit
          86.0
          value
          60
        3. group Id
          BG002
          lower Limit
          37.0
          upper Limit
          93.0
          value
          61
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          112
        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
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          140
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      69
    2. group Id
      BG001
      value
      71
    3. group Id
      BG002
      value
      140
    units
    Participants
groups
  1. description
    Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
    id
    BG000
    title
    Arm I (Doxepin-Placebo)
  2. description
    Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
    id
    BG001
    title
    Arm II (Placebo-Doxepin)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          39.0
          upper Limit
          93.0
          value
          62
        2. group Id
          BG001
          lower Limit
          37.0
          upper Limit
          86.0
          value
          60
        3. group Id
          BG002
          lower Limit
          37.0
          upper Limit
          93.0
          value
          61
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          112
        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
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          140
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice