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NCT00602667 · OUTCOME

Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity

Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma · Source last updated 2026-05-19

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

Measure
NUMBER
Unit
Percentage of courses delayed
Interval / dispersion
95% Confidence Interval
Time frame
From on-study date up to 4 months after on-study date

What was measured

For the subset of patients with metastatic disease (high-risk group patients), during induction, the proportion percentage of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity will be calculated. Patients were to receive 4 courses of induction and then consolidation chemotherapy.

Analysis population: Eligible high-risk group patients who started therapy were included in this analysis (n=76). 1 patient enrolled on the high-risk arm did not start therapy due to early disease progression and was excluded. Courses 2-4 of induction and the 1st consolidation course were used in this analysis. 76 patients (with 263 courses) were included.

Groups in this outcome

High-Risk Group

Patients with central nervous system (CNS) metastatic disease

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 Group76

Analysis denominator · courses

GroupSource count
High-Risk Group263

Reported measurements

Source class 1
Values in Percentage of courses delayed · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High-Risk Group3.8Not reported1.86.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        6.9
        value
        3.8
denom Units Selected
courses
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      263
    units
    courses
description
For the subset of patients with metastatic disease (high-risk group patients), during induction, the proportion percentage of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity will be calculated. Patients were to receive 4 courses of induction and then consolidation chemotherapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with central nervous system (CNS) metastatic disease
    id
    OG000
    title
    High-Risk Group
param Type
NUMBER
population Description
Eligible high-risk group patients who started therapy were included in this analysis (n=76). 1 patient enrolled on the high-risk arm did not start therapy due to early disease progression and was excluded. Courses 2-4 of induction and the 1st consolidation course were used in this analysis. 76 patients (with 263 courses) were included.
reporting Status
POSTED
time Frame
From on-study date up to 4 months after on-study date
title
Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
type
SECONDARY
type Units Analyzed
courses
unit Of Measure
Percentage of courses delayed

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

Preserved source evidence · Not medical advice