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NCT00895245 · OUTCOME

Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen

Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy · Source last updated 2017-05-18

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
120 hours following cisplatin infusion

What was measured

Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.

Groups in this outcome

Arm I

Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r

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

Analysis denominator · Participants

GroupSource count
Arm I6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.
groups
  1. description
    Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r
    id
    OG000
    title
    Arm I
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
120 hours following cisplatin infusion
title
Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice