Safety and effectiveness of bevacizumab in Japanese patients with malignant glioma: a post-marketing surveillance study.

ABSTRACT:

Objective

This surveillance study was conducted to verify the post-market safety and effectiveness of bevacizumab, which was approved in Japan in 2013 for the treatment of patients with newly diagnosed and or recurrent malignant glioma.

Methods

This was a prospective, observational, multicenter post-marketing surveillance study. Patients with newly diagnosed or recurrent malignant glioma scheduled for bevacizumab treatment were enrolled. The incidence and severity of adverse drug reactions were calculated. The effectiveness of bevacizumab was assessed by the 1-year survival rate and the overall survival rate.

Results

The safety analysis set and the effectiveness analysis set each comprised 258 of the 268 enrolled patients: tumours were newly diagnosed in 80 patients (

SUBMITTER: Motoo N 

PROVIDER: S-EPMC6923818 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature