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NCT01363479 · FLOW

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An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting · Source last updated 2021-09-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Oral palonosetron Dexamethasone
    id
    FG000
    title
    Oral Palonosteron Plus Dexamethasone
  2. description
    Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. I.V. palonosetron Dexamethasone
    id
    FG001
    title
    I.V. Palonosetron Plus Dexamethasone
periods
  1. milestones
    1. achievements
      1. comment
        number of randomised patients
        group Id
        FG000
        num Subjects
        371
      2. comment
        number of randomised patients
        group Id
        FG001
        num Subjects
        372
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        359
      2. group Id
        FG001
        num Subjects
        351
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        21
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 743 patients were randomized (ITT population), 739 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population), 738 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population) and chemotherapy (FAS population)
Complete source fields
groups
  1. description
    Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Oral palonosetron Dexamethasone
    id
    FG000
    title
    Oral Palonosteron Plus Dexamethasone
  2. description
    Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. I.V. palonosetron Dexamethasone
    id
    FG001
    title
    I.V. Palonosetron Plus Dexamethasone
periods
  1. milestones
    1. achievements
      1. comment
        number of randomised patients
        group Id
        FG000
        num Subjects
        371
      2. comment
        number of randomised patients
        group Id
        FG001
        num Subjects
        372
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        359
      2. group Id
        FG001
        num Subjects
        351
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        21
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 743 patients were randomized (ITT population), 739 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population), 738 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population) and chemotherapy (FAS population)

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

Preserved source evidence · Not medical advice