TABLE 3.

Safety outcomes by treatment group in unadjusted analyses and after multivariable adjustment

	Nivolumab—no. (%)	Sorafenib—no. (%)	Unadjusted analysis ‐ OR for nivolumab compared to sorafenib (95% CI)	Multivariable analysis ‐ OR for nivolumab compared to sorafenib (95% CI)
Hospitalization for hepatic decompensation	17 (22%)	69 (16%)	1.44 (0.79–2.60)	1.03 (0.49–2.14)
Hospitalization for venous thromboembolism	13 (16%)	37 (9%)	2.10 (1.06–4.15)	1.75 (0.82–3.75)
Hospitalization for GI bleeding (including variceal)	7 (9%)	36 (8%)	1.08 (0.46–2.49)	1.03 (0.42–2.52)
Hospitalization for ischemic stroke or myocardial infarction	0 (0%)	4 (1%)	NA a	NA a

Abbreviations: CI, confidence interval; NA, not applicable; OR, odds ratio.

^a Insufficient number of events to estimate OR or perform multivariate modeling.