PT - JOURNAL ARTICLE AU - Reynolds, Kerry L AU - Arora, Shaily AU - Elayavilli, Ravikumar Komandur AU - Louv, William C AU - Schaller, Teilo H AU - Khandelwal, Aakanksha AU - Rothenberg, Mace AU - Khozin, Sean AU - Guidon, Amanda C AU - Dougan, Michael AU - Zubiri, Leyre AU - Petrillo, Laura AU - Sise, Meghan E AU - Villani, Alexandra-Chloe AU - Johnson, Douglas B AU - Rahma, Osama AU - Sharon, Elad TI - Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data AID - 10.1136/jitc-2021-002896 DP - 2021 Jul 01 TA - Journal for ImmunoTherapy of Cancer PG - e002896 VI - 9 IP - 7 4099 - http://jitc.bmj.com/content/9/7/e002896.short 4100 - http://jitc.bmj.com/content/9/7/e002896.full SO - J Immunother Cancer2021 Jul 01; 9 AB - Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing. The use of ICIs in combination with other forms of cancer therapy, such as chemotherapy, radiotherapy, or targeted therapy, is also expanding. However, immune-related adverse events (irAEs) can be serious in up to a third of patients. Critical questions remain surrounding the characteristics and outcomes of irAEs, and how they may affect the overall risk–benefit relationship for combination therapies. This article proposes a framework for irAE classification and reporting, and identifies limitations in the capture and sharing of data on irAEs from current clinical trial and real-world data. We outline key gaps and suggestions for clinicians, clinical investigators, drug sponsors, patients, and other stakeholders to make these critical data more available to researchers for pooled analysis, to advance contemporary understanding of irAEs, and ultimately improve the efficacy of ICIs.