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NCT00884741 · OUTCOME

Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0

Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma · Source last updated 2019-07-24

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 30 days

What was measured

AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.

Analysis population: Eligible randomized patients with adverse event data who started study treatment.

Groups in this outcome

Randomized Arm 1: TMZ+RT + Placebo

Temozolomide post-randomization,Radiation therapy post-randomization, placebo

Randomized Arm 2: TMZ+RT + Bevacizumab

Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab

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

Analysis denominator · Participants

GroupSource count
Randomized Arm 1: TMZ+RT + Placebo300
Randomized Arm 2: TMZ+RT + Bevacizumab303

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Randomized Arm 1: TMZ+RT + Placebo87Not reportedNot reportedNot reportedNot reported
Randomized Arm 2: TMZ+RT + Bevacizumab97Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.42
    p Value Comment
    Two-sided
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.42
    p Value Comment
    Two-sided
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        87
      2. group Id
        OG001
        value
        97
denoms
  1. counts
    1. group Id
      OG000
      value
      300
    2. group Id
      OG001
      value
      303
    units
    Participants
description
AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.
groups
  1. description
    Temozolomide post-randomization,Radiation therapy post-randomization, placebo
    id
    OG000
    title
    Randomized Arm 1: TMZ+RT + Placebo
  2. description
    Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
    id
    OG001
    title
    Randomized Arm 2: TMZ+RT + Bevacizumab
param Type
NUMBER
population Description
Eligible randomized patients with adverse event data who started study treatment.
reporting Status
POSTED
time Frame
Up to 30 days
title
Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice