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NCT02557035 · BASELINE

Baseline characteristics

An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting · Source last updated 2018-06-20

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
      225
    2. group Id
      BG001
      value
      215
    3. group Id
      BG002
      value
      440
    units
    Participants
groups
  1. description
    Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Palonosetron Dexamethasone
    id
    BG000
    title
    I.V. Palonosetron Infusion Plus Dexamethasone
  2. description
    Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Palonosetron Dexamethasone
    id
    BG001
    title
    I.V. Palonosetron Bolus Plus Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.7
          value
          59.9
        2. group Id
          BG001
          spread
          8.5
          value
          58.9
        3. group Id
          BG002
          spread
          8.6
          value
          59.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          145
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          295
        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
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          225
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          440
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          206
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          220
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Grade 2
    description
    The ECOG Scale is a standard criteria for measuring how the cancer disease impacts a patient's daily living abilities (known to physicians and researchers as a patient's performance status). It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). There 6 grades, where the performance gets worsening from 0 (patient is fully active, able to carry on all pre-disease performance without restriction) to 5 (patient is dead).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          160
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          305
        title
        None
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          125
        title
        Occasional
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        title
        Regular
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Alcohol consumption
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          158
        title
        non-smoker
      2. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          151
        title
        Ex-smoker
      3. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          126
        title
        Regular
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Occasional
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tobacco consumption
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      225
    2. group Id
      BG001
      value
      215
    3. group Id
      BG002
      value
      440
    units
    Participants
groups
  1. description
    Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Palonosetron Dexamethasone
    id
    BG000
    title
    I.V. Palonosetron Infusion Plus Dexamethasone
  2. description
    Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Palonosetron Dexamethasone
    id
    BG001
    title
    I.V. Palonosetron Bolus Plus Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.7
          value
          59.9
        2. group Id
          BG001
          spread
          8.5
          value
          58.9
        3. group Id
          BG002
          spread
          8.6
          value
          59.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          145
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          295
        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
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          225
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          440
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          206
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          220
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Grade 2
    description
    The ECOG Scale is a standard criteria for measuring how the cancer disease impacts a patient's daily living abilities (known to physicians and researchers as a patient's performance status). It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). There 6 grades, where the performance gets worsening from 0 (patient is fully active, able to carry on all pre-disease performance without restriction) to 5 (patient is dead).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          160
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          305
        title
        None
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          125
        title
        Occasional
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        title
        Regular
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Alcohol consumption
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          158
        title
        non-smoker
      2. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          151
        title
        Ex-smoker
      3. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          126
        title
        Regular
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Occasional
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tobacco consumption
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice