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NCT01376297 · BASELINE

Baseline characteristics

A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting · Source last updated 2014-11-17

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
      308
    2. group Id
      BG001
      value
      104
    3. group Id
      BG002
      value
      412
    units
    Participants
groups
  1. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone
    id
    BG000
    title
    Netupitant and Palonosetron Plus Dexamethasone
  2. description
    Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle. Aprepitant Palonosetron Dexamethasone
    id
    BG001
    title
    Aprepitant and 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
          10.44
          value
          56.5
        2. group Id
          BG001
          spread
          11.70
          value
          56.9
        3. group Id
          BG002
          spread
          10.76
          value
          56.6
    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
          155
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          206
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          206
        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
          258
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          345
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          64
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
population Description
Safety Population, i.e. patients receiving study drugs (either netupitant/palonosetron combination or aprepitant/palonosetron regimen, both with dexamethasone)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      308
    2. group Id
      BG001
      value
      104
    3. group Id
      BG002
      value
      412
    units
    Participants
groups
  1. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone
    id
    BG000
    title
    Netupitant and Palonosetron Plus Dexamethasone
  2. description
    Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle. Aprepitant Palonosetron Dexamethasone
    id
    BG001
    title
    Aprepitant and 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
          10.44
          value
          56.5
        2. group Id
          BG001
          spread
          11.70
          value
          56.9
        3. group Id
          BG002
          spread
          10.76
          value
          56.6
    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
          155
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          206
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          206
        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
          258
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          345
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          64
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
population Description
Safety Population, i.e. patients receiving study drugs (either netupitant/palonosetron combination or aprepitant/palonosetron regimen, both with dexamethasone)

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Preserved source evidence · Not medical advice