Most frequent events (≥5% in either group) Table 3 Treatment-Related Adverse Events Event, n (%) In addition, one death was reported with nivolumab plus ipilimumab due to both study treatment toxicity (autoimmune colitis) and disease progression. One treatment-related death occurred in the nivolumab group due to pneumonitis, and three in the nivolumab plus ipilimumab group, with one each due to hepatitis, pneumonitis, and encephalitis.

TRAEs led to discontinuation in 2.7% of patients receiving nivolumab and 13.5% of those receiving nivolumab plus ipilimumab the majority of these events were grade 3 to 4 and are detailed in Supplementary Table 2. The most frequent (≥10%) TRAEs of any grade were fatigue (12.2%) with nivolumab, and diarrhea (19.8%), fatigue (18.8%), pruritus (16.7%), and nausea, increased aspartate aminotransferase and decreased appetite (each 10.4%) with nivolumab plus ipilimumab. Grade 3 to 4 TRAEs occurred in 12.9% of patients receiving nivolumab and 37.5% of those receiving nivolumab plus ipilimumab. Any-grade TRAEs were reported in 53.7% of patients in the nivolumab group and 68.8% of patients in the nivolumab plus ipilimumab group ( Table 3).

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