CISH and hepatobiliary disorder: In the JADER database, four positive SOCs were identified: infections and infestations (94 cases; ROR 3.68 [95% CI 2.91–4.64], PRR 3.02, EBGM05 2.39, IC025–0.08), investigations (61 cases; ROR 1.78 [95% CI 1.36–2.35], PRR 1.66, EBGM05 1.26, IC025–0.94), general disorders and administration site conditions (36 cases; ROR 1.47 [95% CI 1.05–2.08], PRR 1.43, EBGM05 1.01, IC025–1.16), and hepatobiliary disorders (33 cases; ROR 2.22 [95% CI 1.55–3.17], PRR 2.11, EBGM05 1.48, IC025–0.59) (Figure 3B).