Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02517021 · BASELINE

Baseline characteristics

A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination 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
      203
    2. group Id
      BG001
      value
      201
    3. group Id
      BG002
      value
      404
    units
    Participants
groups
  1. description
    Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Pro-netupitant/Palonosetron Dexamethasone
    id
    BG000
    title
    Pro-netupitant/Palonosetron Plus Dexamethasone
  2. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant/Palonosetron Dexamethasone
    id
    BG001
    title
    Netupitant/Palonosetron 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
          9.7
          value
          60.0
        2. group Id
          BG001
          spread
          10.6
          value
          58.9
        3. group Id
          BG002
          spread
          10.2
          value
          59.5
    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
          96
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          190
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          214
        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
          1
        3. group Id
          BG002
          value
          1
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          401
        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
          81
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          164
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          117
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          230
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        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
          126
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          244
        title
        None
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          151
        title
        Occasional
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
        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
          83
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          160
        title
        Non-smoker
      2. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          131
        title
        Ex-smoker
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Occasional
      4. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          113
        title
        Regular
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tobacco consumption
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      203
    2. group Id
      BG001
      value
      201
    3. group Id
      BG002
      value
      404
    units
    Participants
groups
  1. description
    Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Pro-netupitant/Palonosetron Dexamethasone
    id
    BG000
    title
    Pro-netupitant/Palonosetron Plus Dexamethasone
  2. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant/Palonosetron Dexamethasone
    id
    BG001
    title
    Netupitant/Palonosetron 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
          9.7
          value
          60.0
        2. group Id
          BG001
          spread
          10.6
          value
          58.9
        3. group Id
          BG002
          spread
          10.2
          value
          59.5
    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
          96
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          190
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          214
        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
          1
        3. group Id
          BG002
          value
          1
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          401
        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
          81
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          164
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          117
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          230
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        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
          126
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          244
        title
        None
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          151
        title
        Occasional
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
        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
          83
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          160
        title
        Non-smoker
      2. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          131
        title
        Ex-smoker
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Occasional
      4. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          113
        title
        Regular
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tobacco consumption
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice