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NCT04541355 · BASELINE

Baseline characteristics

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin · Source last updated 2024-06-28

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
      16
    units
    Participants
groups
  1. description
    Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Cisplatin, Radiotherapy, STS
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      40-49 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      50-59 years old
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      60-69 years old
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      70-79 years old
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        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
          16
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        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
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          14
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        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
          16
      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
      16
    units
    Participants
groups
  1. description
    Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Cisplatin, Radiotherapy, STS
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      40-49 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      50-59 years old
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      60-69 years old
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      70-79 years old
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        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
          16
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        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
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          14
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        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
          16
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice