At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Temodal (Temozolomide) Post Marketing Surveillance Protocol
In Brief
An observational study evaluating Temozolomide and Radiotherapy for Glioblastoma and 2 related conditions. Completed, enrolled 682 participants.
Detailed Summary
The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt: * Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events); * Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction); * Adverse Event caused by misuse, abuse, or drug interactions; * Other information concerned with safety or efficacy.
Study Details
Timeline
Interventions
Administration of temozolomide based on the product labeling.
Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.