4.2 Cardiovascular Adverse Event Signal Detection Using the FAERS Database
Based on the criteria for the 4 algorithms (ROR,PRR,BCPNN, MGPS), there were 17 cardiac AEs signals detected in regorafenib, 15 cardiac AEs signals detected in lenvatinib, 57 cardiac AEs signals detected in sorafenib and 27 cardiac AEs signals detected in cabozantinib, respectively(Table 4, Fig 2). Among all the cardiac AEs signals, hypertension accounts for the most reported cardiac AEs in all these four TKIs. Furthermore, cardiac failure or cardiac failure acute signals were detected in all these four TKIs. Lenvatinib had the highest ROR[7.7(3.46,17.17)], while the ROR in regorafenib sorafenib and cabozantinib was 1.42(1.05,1.92), 2.48(1.44,4.27) and 5.92(4.13,8.47), respectively. There were cardiac AEs that show no class effect but significantly were over-reported in specific TKI. Acute myocardial infarction were mainly detected in lenvatinib[ROR=7.91(5.64,11.09)] and sorafenib[ROR=2.22(1.74, 2.84)]. No acute myocardial infarction signal were detected in regorafenib nor cabozantinib. Furthermore, acute coronary syndrome were also detected in lenvatinib[ROR=11.57(6.84, 19.58)] and sorafenib[ROR=2.81(1.87,4.24)]. When it comes to atrial fibrillation, signals were detected in sorafenib[ROR=1.82(1.55,2.14)] and regorafenib[ROR=1.36(1.03,1.81)] . Besides, aortic dissection were detected in sorafenib [ROR=5.08(3.31,7.8)] and regorafenib [ROR=3.39(1.52,7.56)].