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NCT00453336 · BASELINE

Baseline characteristics

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract · Source last updated 2017-02-08

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
      45
    units
    Participants
groups
  1. description
    Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired. Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.
    id
    BG000
    title
    Single Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          34
        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
          30
          upper Limit
          92
          value
          66
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      Oral Cavity Lesions
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Layngeal Lesions
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Other Lesions
    description
    The types of lesions participants had at time of enrollment
    param Type
    NUMBER
    title
    Types of Lesions
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Squamous Cell Carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Severe Dysplasia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Carcinoma in situ
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Verrucous Carcinoma
    param Type
    NUMBER
    title
    Pathology
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      45
    units
    Participants
groups
  1. description
    Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired. Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.
    id
    BG000
    title
    Single Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          34
        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
          30
          upper Limit
          92
          value
          66
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      Oral Cavity Lesions
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Layngeal Lesions
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Other Lesions
    description
    The types of lesions participants had at time of enrollment
    param Type
    NUMBER
    title
    Types of Lesions
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Squamous Cell Carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Severe Dysplasia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Carcinoma in situ
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Verrucous Carcinoma
    param Type
    NUMBER
    title
    Pathology
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice