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NCT01376297 · FLOW

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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.

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
    FG000
    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
    FG001
    title
    Aprepitant and Palonosetron Plus Dexamethasone
periods
  1. milestones
    1. achievements
      1. comment
        number of randomised patients
        group Id
        FG000
        num Subjects
        309
      2. comment
        number of randomised patients
        group Id
        FG001
        num Subjects
        104
      type
      STARTED
    2. achievements
      1. comment
        number of patients completing planned/unplanned chemotherapy cycles
        group Id
        FG000
        num Subjects
        181
      2. comment
        number of patients completing planned/unplanned chemotherapy cycles
        group Id
        FG001
        num Subjects
        55
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        128
      2. group Id
        FG001
        num Subjects
        49
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 413 patients were randomized (ITT population), 412 patients received study drugs i.e.netupitant/palonosetron combination or aprepitant/palonosetron regimen, both with dexamethasone (safety population)
Complete source fields
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
    FG000
    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
    FG001
    title
    Aprepitant and Palonosetron Plus Dexamethasone
periods
  1. milestones
    1. achievements
      1. comment
        number of randomised patients
        group Id
        FG000
        num Subjects
        309
      2. comment
        number of randomised patients
        group Id
        FG001
        num Subjects
        104
      type
      STARTED
    2. achievements
      1. comment
        number of patients completing planned/unplanned chemotherapy cycles
        group Id
        FG000
        num Subjects
        181
      2. comment
        number of patients completing planned/unplanned chemotherapy cycles
        group Id
        FG001
        num Subjects
        55
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        128
      2. group Id
        FG001
        num Subjects
        49
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 413 patients were randomized (ITT population), 412 patients received study drugs i.e.netupitant/palonosetron combination or aprepitant/palonosetron regimen, both with dexamethasone (safety population)

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

Preserved source evidence · Not medical advice