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NCT00492089 · OUTCOME

Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment

Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer · Source last updated 2014-05-09

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
Baseline to 12 weeks

What was measured

Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.

Analysis population: Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description.

Groups in this outcome

Arm A: Bevacizumab

Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks

Crossover Arm B: Placebo Then Bevacizumab

Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m\^2 IV as in Arm A

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

Analysis denominator · Participants

GroupSource count
Arm A: Bevacizumab5
Crossover Arm B: Placebo Then Bevacizumab6

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Bevacizumab5Not reportedNot reportedNot reportedNot reported
Crossover Arm B: Placebo Then Bevacizumab6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.
groups
  1. description
    Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks
    id
    OG000
    title
    Arm A: Bevacizumab
  2. description
    Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m\^2 IV as in Arm A
    id
    OG001
    title
    Crossover Arm B: Placebo Then Bevacizumab
param Type
NUMBER
population Description
Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description.
reporting Status
POSTED
time Frame
Baseline to 12 weeks
title
Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice