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NCT00795769 · OUTCOME

Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)

Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant · Source last updated 2017-05-23

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
Baseline up to 120 minutes

What was measured

Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.

Groups in this outcome

Ondansetron Therapy

Patients receive 16mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation. ondansetron: Given IV survey administration: Correlative studies management of therapy complications: Ondansetron IV

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

Analysis denominator · Participants

GroupSource count
Ondansetron Therapy49

Reported measurements

MAT score >2 on arrival and pre-ondansetron
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ondansetron Therapy23Not reportedNot reportedNot reportedNot reported
Baseline MAT score >2 prior to first ASCT infusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ondansetron Therapy9Not reportedNot reportedNot reportedNot reported
MAT score increases >2 by end of infusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ondansetron Therapy12Not reportedNot reportedNot reportedNot reported
Number of patients that vomited
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ondansetron Therapy9Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.03
    statistical Method
    t-test, 1 sided
  2. group Description
    Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p \<0.0001). PMID: 21372706 reference for historical data at FHCRC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    t-test, 1 sided
Complete source fields
analyses
  1. group Description
    18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.03
    statistical Method
    t-test, 1 sided
  2. group Description
    Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p \<0.0001). PMID: 21372706 reference for historical data at FHCRC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    t-test, 1 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    MAT score >2 on arrival and pre-ondansetron
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Baseline MAT score >2 prior to first ASCT infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    MAT score increases >2 by end of infusion
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Number of patients that vomited
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    units
    Participants
description
Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.
groups
  1. description
    Patients receive 16mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation. ondansetron: Given IV survey administration: Correlative studies management of therapy complications: Ondansetron IV
    id
    OG000
    title
    Ondansetron Therapy
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Baseline up to 120 minutes
title
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice