LAUSR

Key Points Question What is the postmarketing safety profile of sipuleucel-T in the United States? Findings The US Food and Drug Administration’s Adverse Event Reporting System received 3216 reports for sipuleucel-T from 2010 through 2017. This case series study identified disproportionate reporting for infusion-associated reactions, infections, certain thromboembolic events, and transient ischemic attacks. Meaning The spectrum of adverse events reported for sipuleucel-T was consistent with the safety experience described in clinical studies and the package insert, and no new safety concerns were identified.