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NCT01339260 · BASELINE

Baseline characteristics

An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting · Source last updated 2014-11-26

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
      725
    2. group Id
      BG001
      value
      725
    3. group Id
      BG002
      value
      1450
    units
    Participants
groups
  1. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone
    id
    BG000
    title
    Netupitant and Palonosetron Plus Dexamethasone
  2. description
    Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle Palonosetron Dexamethasone
    id
    BG001
    title
    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
          10.66
          value
          53.7
        2. group Id
          BG001
          spread
          10.65
          value
          54.1
        3. group Id
          BG002
          spread
          10.65
          value
          53.9
    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
          711
        2. group Id
          BG001
          value
          711
        3. group Id
          BG002
          value
          1422
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          28
        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
          574
        2. group Id
          BG001
          value
          579
        3. group Id
          BG002
          value
          1153
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          204
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          82
      title
      Hispanic
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
population Description
Safety population ie patients receiving either netupitant/palonosetron combination or palonosetron, both plus dexamethasone
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      725
    2. group Id
      BG001
      value
      725
    3. group Id
      BG002
      value
      1450
    units
    Participants
groups
  1. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone
    id
    BG000
    title
    Netupitant and Palonosetron Plus Dexamethasone
  2. description
    Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle Palonosetron Dexamethasone
    id
    BG001
    title
    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
          10.66
          value
          53.7
        2. group Id
          BG001
          spread
          10.65
          value
          54.1
        3. group Id
          BG002
          spread
          10.65
          value
          53.9
    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
          711
        2. group Id
          BG001
          value
          711
        3. group Id
          BG002
          value
          1422
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          28
        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
          574
        2. group Id
          BG001
          value
          579
        3. group Id
          BG002
          value
          1153
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          204
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          82
      title
      Hispanic
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
population Description
Safety population ie patients receiving either netupitant/palonosetron combination or palonosetron, both plus dexamethasone

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Preserved source evidence · Not medical advice