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NCT01536392 · BASELINE

Baseline characteristics

Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation · Source last updated 2021-06-11

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
      41
    2. group Id
      BG001
      value
      34
    3. group Id
      BG002
      value
      75
    units
    Participants
groups
  1. description
    8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.
    id
    BG000
    title
    Arm 1: Transdermal Granisetron
  2. description
    8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
    id
    BG001
    title
    Arm 2: Oral Ondansetron
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          68
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        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
          21
          upper Limit
          80
          value
          45
        2. group Id
          BG001
          lower Limit
          30
          upper Limit
          86
          value
          51
        3. group Id
          BG002
          lower Limit
          21
          upper Limit
          86
          value
          49
    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
          41
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          75
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          32
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          62
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          75
      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
      41
    2. group Id
      BG001
      value
      34
    3. group Id
      BG002
      value
      75
    units
    Participants
groups
  1. description
    8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.
    id
    BG000
    title
    Arm 1: Transdermal Granisetron
  2. description
    8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
    id
    BG001
    title
    Arm 2: Oral Ondansetron
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          68
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        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
          21
          upper Limit
          80
          value
          45
        2. group Id
          BG001
          lower Limit
          30
          upper Limit
          86
          value
          51
        3. group Id
          BG002
          lower Limit
          21
          upper Limit
          86
          value
          49
    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
          41
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          75
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          32
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          62
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          75
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice