Integrated Safety Data From 4 Randomized, Double-Blind, Controlled Trials of Autologous Cellular Immunotherapy With Sipuleucel-T in Patients With Prostate Cancer

Sipuleucel-T therapy in patients with prostate cancer has a side effect profile that is characterized by mild to moderate, short-term, reversible adverse events. There was no evidence of a treatment related increase in autoimmune complications or secondary malignancies after treatment with sipuleucel-T. Sipuleucel-T can be administered safely in the outpatient setting.