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NCT01736917 · OUTCOME

Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors · Source last updated 2016-05-25

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Days 1-8 of chemotherapy regimen

What was measured

complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications

Groups in this outcome

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied. * Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days). Acute emesis prophylaxis: * Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards. * Dexamethasone 20mg PO (orally) daily, D1 and 2 * Fosaprepitant 150mg IV on day 3 Delayed emesis prophylaxis: * Fosaprepitant 150mg IV on D5 * Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator * No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl

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

Analysis denominator · Participants

GroupSource count
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone54

Reported measurements

acute phase(days 1 through 5)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone29.6Not reportedNot reportedNot reportedNot reported
delayed phase (days 6 through 8)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone46.3Not reportedNot reportedNot reportedNot reported
overall
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone24.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29.6
    title
    acute phase(days 1 through 5)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        46.3
    title
    delayed phase (days 6 through 8)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        24.1
    title
    overall
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    units
    Participants
description
complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications
groups
  1. description
    Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied. * Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days). Acute emesis prophylaxis: * Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards. * Dexamethasone 20mg PO (orally) daily, D1 and 2 * Fosaprepitant 150mg IV on day 3 Delayed emesis prophylaxis: * Fosaprepitant 150mg IV on D5 * Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator * No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl
    id
    OG000
    title
    Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
param Type
NUMBER
reporting Status
POSTED
time Frame
Days 1-8 of chemotherapy regimen
title
Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice