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)].