Temodal Capsule All-Case-Registered Surveillance (Designated Drug Use Investigation) - Evaluation of The Safety and Efficacy of Temodal in Patients With Newly Diagnosed Malignant Glioma (Concomitant With Radiotherapy and Then as Monotherapy) and Relapsed Malignant Glioma (as Monotherapy)
Patients are invited to participate in the study.
Observational Model: Cohort, Time Perspective: Prospective
Safety: observation of hematology, biochemistry, and adverse events (AEs); evaluation of details of occurrence of AEs and unexpected serious AEs, and evaluation of presence or absence of secondary malignancies and causal relationship with temozolomide.
AEs during treatment with temozolomide, serious AEs occurring within 30 days after completion of treatment with temozolomide. Secondary malignancies will be monitored from the start of treatment with temozolomide to final outcome.
Japan: Ministry of Health, Labor and Welfare