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NCT01363479 · OUTCOME

Percentage of Patients With no Emesis

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.

Measure
NUMBER
Unit
percentage of responders
Interval / dispersion
95% Confidence Interval
Time frame
0-24 hours

Analysis population: FAS i.e. patients receiving study drugs and chemotherapy

Groups in this outcome

Oral Palonosteron Plus Dexamethasone

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

I.V. Palonosetron Plus Dexamethasone

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Oral Palonosteron Plus Dexamethasone369
I.V. Palonosetron Plus Dexamethasone369

Reported measurements

Source class 1
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Oral Palonosteron Plus Dexamethasone90.2Not reported86.892.9Not reported
I.V. Palonosetron Plus Dexamethasone86.7Not reported82.989.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        86.8
        upper Limit
        92.9
        value
        90.2
      2. group Id
        OG001
        lower Limit
        82.9
        upper Limit
        89.8
        value
        86.7
denoms
  1. counts
    1. group Id
      OG000
      value
      369
    2. group Id
      OG001
      value
      369
    units
    Participants
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    I.V. Palonosetron Plus Dexamethasone
param Type
NUMBER
population Description
FAS i.e. patients receiving study drugs and chemotherapy
reporting Status
POSTED
time Frame
0-24 hours
title
Percentage of Patients With no Emesis
type
SECONDARY
unit Of Measure
percentage of responders

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

Preserved source evidence · Not medical advice