NCT00723827

Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

Temodal (Temozolomide) Post Marketing Surveillance Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 682 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma
• Glioma
• Astrocytoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Administration of temozolomide based on the product labeling.
RADIATION	Radiotherapy	Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-07-29
• Last updated: 2015-01-30
• Results posted: 2013-01-08