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NCT01339260 · FLOW

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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.

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
    FG000
    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
    FG001
    title
    Palonosetron Plus Dexamethasone
periods
  1. milestones
    1. achievements
      1. comment
        Intent-To-Treat: randomized patients
        group Id
        FG000
        num Subjects
        726
      2. comment
        Intent-To-Treat: randomized patients
        group Id
        FG001
        num Subjects
        729
      type
      STARTED
    2. achievements
      1. comment
        Patients receiving netupitant/palonosetron combination
        group Id
        FG000
        num Subjects
        725
      2. comment
        Patients receiving palonosetron
        group Id
        FG001
        num Subjects
        725
      type
      Safety Population
    3. achievements
      1. comment
        Patients receiving chemotherapy and randomized to netupitant/palonosetron combination
        group Id
        FG000
        num Subjects
        724
      2. comment
        Patients receiving chemotherapy and randomized to palonosetron
        group Id
        FG001
        num Subjects
        725
      type
      Full Analysis Set
    4. achievements
      1. group Id
        FG000
        num Subjects
        719
      2. group Id
        FG001
        num Subjects
        719
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Cycle 1
  2. milestones
    1. achievements
      1. comment
        Patients scheduled to netupitant/palonosetron combination
        group Id
        FG000
        num Subjects
        635
      2. comment
        Patients scheduled to palonosetron
        group Id
        FG001
        num Subjects
        651
      type
      STARTED
    2. achievements
      1. comment
        Patients receiving netupitant/palonosetron combination
        group Id
        FG000
        num Subjects
        635
      2. comment
        Patients receiving palonosetron
        group Id
        FG001
        num Subjects
        651
      type
      Safety Population
    3. achievements
      1. comment
        Patients completing at least number of cycles they were scheduled to
        group Id
        FG000
        num Subjects
        449
      2. comment
        Patients completing at least number of cycles they were scheduled to
        group Id
        FG001
        num Subjects
        458
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        186
      2. group Id
        FG001
        num Subjects
        193
      type
      NOT COMPLETED
    title
    Multi-cycle Extension
pre Assignment Details
1455 patients randomized (ITT population), 1450 received study drug i.e. netupitant/palonosetron combination or palonosetron, both with dexamethasone, in cycle 1 (safety population-cycle 1), 1449 received chemotherapy and study drug (FAS), 1286 received study drug in multi-cycle extension (safety population-multi-cycle extension)
Complete source fields
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
    FG000
    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
    FG001
    title
    Palonosetron Plus Dexamethasone
periods
  1. milestones
    1. achievements
      1. comment
        Intent-To-Treat: randomized patients
        group Id
        FG000
        num Subjects
        726
      2. comment
        Intent-To-Treat: randomized patients
        group Id
        FG001
        num Subjects
        729
      type
      STARTED
    2. achievements
      1. comment
        Patients receiving netupitant/palonosetron combination
        group Id
        FG000
        num Subjects
        725
      2. comment
        Patients receiving palonosetron
        group Id
        FG001
        num Subjects
        725
      type
      Safety Population
    3. achievements
      1. comment
        Patients receiving chemotherapy and randomized to netupitant/palonosetron combination
        group Id
        FG000
        num Subjects
        724
      2. comment
        Patients receiving chemotherapy and randomized to palonosetron
        group Id
        FG001
        num Subjects
        725
      type
      Full Analysis Set
    4. achievements
      1. group Id
        FG000
        num Subjects
        719
      2. group Id
        FG001
        num Subjects
        719
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Cycle 1
  2. milestones
    1. achievements
      1. comment
        Patients scheduled to netupitant/palonosetron combination
        group Id
        FG000
        num Subjects
        635
      2. comment
        Patients scheduled to palonosetron
        group Id
        FG001
        num Subjects
        651
      type
      STARTED
    2. achievements
      1. comment
        Patients receiving netupitant/palonosetron combination
        group Id
        FG000
        num Subjects
        635
      2. comment
        Patients receiving palonosetron
        group Id
        FG001
        num Subjects
        651
      type
      Safety Population
    3. achievements
      1. comment
        Patients completing at least number of cycles they were scheduled to
        group Id
        FG000
        num Subjects
        449
      2. comment
        Patients completing at least number of cycles they were scheduled to
        group Id
        FG001
        num Subjects
        458
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        186
      2. group Id
        FG001
        num Subjects
        193
      type
      NOT COMPLETED
    title
    Multi-cycle Extension
pre Assignment Details
1455 patients randomized (ITT population), 1450 received study drug i.e. netupitant/palonosetron combination or palonosetron, both with dexamethasone, in cycle 1 (safety population-cycle 1), 1449 received chemotherapy and study drug (FAS), 1286 received study drug in multi-cycle extension (safety population-multi-cycle extension)

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Preserved source evidence · Not medical advice