Association between immune-related adverse events during anti–PD-1 therapy and tumor mutational burden

D Bomze, OH Ali, A Bate, L Flatz - JAMA oncology, 2019 - jamanetwork.com
Methods| We retrieved postmarketing data of adverse events from the US Food and Drug
Administration Adverse Event Reporting System (FAERS) from July 1, 2014, to March 31,
2019. According to the ethics committee policy of the EKOS (Ethikkommission Ostschweiz,
Switzerland), this study was exempt from ethical review because all analyzed data sets are
deidentified and publicly available. We considered only reports for which the anti–PD-1
agents nivolumab or pembrolizumab were the suspected cause of adverse events. Anti–PD …