Temodal (Temozolomide) Post Marketing Surveillance Protocol
Observational Model: Cohort, Time Perspective: Prospective
Number of Participants Experiencing Adverse Events (AEs)
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.
Complete study duration & 30 days after completion (up to approximately 7.5 months)
South Korea: Institutional Review Board