Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Full description
Patients are invited to participate in the study.
Enrollment
Sex
Volunteers
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.
Trial design
1,804 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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