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)
N/A
N/A
Both
Glioma, Astrocytoma
Trial Information
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.
Inclusion Criteria:
- All patients treated with temozolomide for newly diagnosed malignant glioma
(concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma
(as monotherapy).
Exclusion Criteria:
- Patients with a history of hypersensitivity to temozolomide or dacarbazine.
- Pregnant women and women who may be pregnant.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
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.
Outcome Time Frame:
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.
Safety Issue:
Yes
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
P05062
NCT ID:
NCT00705198
Start Date:
September 2006
Completion Date:
October 2016
Related Keywords:
- Glioma
- Astrocytoma
- Astrocytoma
- Glioma
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