Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
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.