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NCT00331760 · OUTCOME

Percentage of Patients With Grade 2+ Bowel Adverse Events

Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery · Source last updated 2019-02-26

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
95% Confidence Interval
Time frame
From the start of treatment to 90 days.

What was measured

Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.

Analysis population: Eligible patients who started study treatment

Groups in this outcome

Endometrial Cancer: IMRT

Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)

Cervical Cancer: IMRT + Chemotherapy (Cisplatin)

Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)

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

Analysis denominator · Participants

GroupSource count
Endometrial Cancer: IMRT43
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)40

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Endometrial Cancer: IMRT27.9Not reported16.642.8Not reported
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)22.5Not reported12.137.7Not reported

Source statistical analyses

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

  1. group Description
    A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.12
    statistical Method
    Chi-squared
  2. group Description
    A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.043
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Description
    A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.12
    statistical Method
    Chi-squared
  2. group Description
    A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.043
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.6
        upper Limit
        42.8
        value
        27.9
      2. group Id
        OG001
        lower Limit
        12.1
        upper Limit
        37.7
        value
        22.5
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.
dispersion Type
95% Confidence Interval
groups
  1. description
    Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
    id
    OG000
    title
    Endometrial Cancer: IMRT
  2. description
    Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
    id
    OG001
    title
    Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
param Type
NUMBER
population Description
Eligible patients who started study treatment
reporting Status
POSTED
time Frame
From the start of treatment to 90 days.
title
Percentage of Patients With Grade 2+ Bowel Adverse Events
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice