Temodal (Temozolomide) Post Marketing Surveillance Protocol
N/A
N/A
N/A
N/A
N/A
Not Enrolling
Both
Glioblastoma, Glioma, Astrocytoma
Both
Glioblastoma, Glioma, Astrocytoma
Trial Information
Temodal (Temozolomide) Post Marketing Surveillance Protocol
Inclusion Criteria:
- Participants who are prescribed with temozolomide by local labeling:
- participants with newly diagnosed glioblastoma multiforme;
- participants with malignant glioma, such as glioblastoma multiforme or
anaplastic astrocytoma, showing recurrence or progression after standard
therapy.
Exclusion Criteria:
- N/A
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of Participants Experiencing Adverse Events (AEs)
Outcome Description:
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.
Outcome Time Frame:
Complete study duration & 30 days after completion (up to approximately 7.5 months)
Safety Issue:
Yes
Authority:
South Korea: Institutional Review Board
Study ID:
P05557
NCT ID:
NCT00723827
Start Date:
March 2008
Completion Date:
September 2011
Related Keywords:
- Glioblastoma
- Glioma
- Astrocytoma
- Astrocytoma
- Glioblastoma
- Glioma
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