Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00304031 · OUTCOME

Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma · Source last updated 2020-06-09

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

What was measured

Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Analysis occurred after 647 deaths were reported.

Analysis population: Randomized eligible patients with any adverse events reported as possibly/probably/definitely related to protocol treatment

Groups in this outcome

Conventional Adjuvant TMZ

Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.

Dose-dense Adjuvant TMZ

Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ351
Dose-dense Adjuvant TMZ369

Reported measurements

Source class 1

Grade 0,1,2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ231Not reportedNot reportedNot reportedNot reported
Dose-dense Adjuvant TMZ175Not reportedNot reportedNot reportedNot reported

Grade 3,4,5

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ120Not reportedNot reportedNot reportedNot reported
Dose-dense Adjuvant TMZ194Not 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
    p Value
    <0.001
    statistical Comment
    Two-sided significance level of 0.05
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    statistical Comment
    Two-sided significance level of 0.05
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        231
      2. group Id
        OG001
        value
        175
      title
      Grade 0,1,2
    2. measurements
      1. group Id
        OG000
        value
        120
      2. group Id
        OG001
        value
        194
      title
      Grade 3,4,5
denoms
  1. counts
    1. group Id
      OG000
      value
      351
    2. group Id
      OG001
      value
      369
    units
    Participants
description
Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Analysis occurred after 647 deaths were reported.
groups
  1. description
    Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
    id
    OG000
    title
    Conventional Adjuvant TMZ
  2. description
    Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
    id
    OG001
    title
    Dose-dense Adjuvant TMZ
param Type
COUNT_OF_PARTICIPANTS
population Description
Randomized eligible patients with any adverse events reported as possibly/probably/definitely related to protocol treatment
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
title
Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice