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NCT00354744 · OUTCOME

Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy

High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma · Source last updated 2020-01-29

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 enrollment to up to 2 years

What was measured

Adverse events are reported for patients receiving concurrent irinotecan hydrochloride and radiotherapy.

Analysis population: Percentage of patients experiencing a grade 3/4/5 toxicity in a course.

Groups in this outcome

High_Risk_Rhabdomyosarcoma

Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.

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

Analysis denominator · Participants

GroupSource count
High_Risk_Rhabdomyosarcoma109

Reported measurements

Course 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High_Risk_Rhabdomyosarcoma53.3Not reported43.463.0Not reported
Course 2
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High_Risk_Rhabdomyosarcoma68.4Not reported58.277.4Not reported
Course 3
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High_Risk_Rhabdomyosarcoma79.3Not reported69.387.3Not reported
Course 4
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High_Risk_Rhabdomyosarcoma55.7Not reported43.367.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.4
        upper Limit
        63.0
        value
        53.3
    title
    Course 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.2
        upper Limit
        77.4
        value
        68.4
    title
    Course 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.3
        upper Limit
        87.3
        value
        79.3
    title
    Course 3
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.3
        upper Limit
        67.6
        value
        55.7
    title
    Course 4
denoms
  1. counts
    1. group Id
      OG000
      value
      109
    units
    Participants
description
Adverse events are reported for patients receiving concurrent irinotecan hydrochloride and radiotherapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
    id
    OG000
    title
    High_Risk_Rhabdomyosarcoma
param Type
NUMBER
population Description
Percentage of patients experiencing a grade 3/4/5 toxicity in a course.
reporting Status
POSTED
time Frame
From enrollment to up to 2 years
title
Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy
type
PRIMARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice