• Grade 3-4 adverse reactions were reported in 10.3% of patients receiving OPDIVO and 2.3% of patients receiving placebo.
• A fatal adverse reaction occurred in 1 (0.2%) patient receiving OPDIVO (heart failure and acute kidney injury).
• Serious adverse reactions occurred in 4.8% of patients receiving OPDIVO. The most frequently reported serious adverse reactions (occurring in >1% patients) were colitis, diarrhea, adrenal insufficiency and myocarditis.
Treatment discontinued for adverse reactions in 14.7% of patients receiving OPDIVO.