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NCT00589121 · OUTCOME

Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events

Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg · Source last updated 2019-06-12

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.

What was measured

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the 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 AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Analysis population: All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)

Groups in this outcome

Cohort B - No Chemotherapy

Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost

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

Analysis denominator · Participants

GroupSource count
Cohort B - No Chemotherapy79

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort B - No Chemotherapy38.0Not reported27.349.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.3
        upper Limit
        49.6
        value
        38.0
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    units
    Participants
description
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the 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 AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
dispersion Type
95% Confidence Interval
groups
  1. description
    Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
    id
    OG000
    title
    Cohort B - No Chemotherapy
param Type
NUMBER
population Description
All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
reporting Status
POSTED
time Frame
From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.
title
Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice