TABLE 2

Treatment-Related ARs in Safety Population of SIRveNIB, SARAH, and SORAMIC Trials

SIRTSorafenibPRisk difference
StudySIRveNIBSARAHSORAMIC*CombinedSIRveNIBSARAHSORAMICCombinedRisk95% CI
AE (%)41/130 (31.5)173/226 (77.0)113/159 (71.1)327/515 (63.5)121/162 (74.7)203/216 (94.0)139/197 (70.6)463/575 (80.5)0.01−0.17−0.22 to −0.12
AE ≥ 3 (%)17/130 (13.1)92/226 (41.0)40/159 (25.2)149/515 (28.9)61/162 (37.7)136/216 (63.0)52/197 (26.4)249/575 (43.3)<0.01−0.14−0.20 to −0.09
SAEs (%)6/130 (4.6)45/226 (20)63/159 (39.6)114/515 (22.1)15/162 (9.3)56/216 (26.0)78/197 (39.6)149/575 (25.9)0.3−0.05−0.12 to 0.02
  • * In SIRT arm, 114/159 patients received sorafenib after SIRT.

  • SAE = serious AE.