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NCT00293384 · OUTCOME

Toxicity Grade 3, 4, or 5

Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant · Source last updated 2016-03-15

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
at 0-120 hours

Groups in this outcome

Aprepitant, Dexamethasone, Cytoxan & Kytril

Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.

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

Analysis denominator · Participants

GroupSource count
Aprepitant, Dexamethasone, Cytoxan & Kytril35

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Aprepitant, Dexamethasone, Cytoxan & Kytril2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    proportion
    param Value
    0.06
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    proportion
    param Value
    0.06
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
groups
  1. description
    Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
    id
    OG000
    title
    Aprepitant, Dexamethasone, Cytoxan & Kytril
param Type
NUMBER
reporting Status
POSTED
time Frame
at 0-120 hours
title
Toxicity Grade 3, 4, or 5
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice