4.1 Characteristics of Patients
Overall, A total of 14464087 reports were documented in the full FAERS
database during the study period, of whom 82682[sorafenib,
n=31361(37.93%); regorafenib, n=13826(16.72%); lenvatinib,
n=8884(10.74%); cabozantinib, n=28611(34.6%)] were reported as
TKIs-related AEs. Moreover, 4708 cardiac AEs reports identified TKIs as
the primary suspected drugs. Among them, 1994 reports were identified as
the suspected drug related to sorafenib; 630 reports were identified as
the suspected drug related to regorafenib. 318 reports were identified
as the suspected drug related to lenvatinib. 1766 reports were
identified as the suspected drug related to cabozantinib. According to
our results, males were more prone
to be affected by cardiac AEs than females in patients taking sorafenib,
cabozantinib(69.9% vs 26.1%, 68.4% vs 28.8%, respectively), while
the ratio of male to female was similar among patients taking
regorafenib or lenvatinib(56.8% vs 40.3%, 48.7% vs 51.3%,
respectively). Age may be a risk factor,
as most patients who experienced
cardiac AEs while taking sorafenib(52.6%), lenvatinib(55.7%) or
regorafenib(45.7%) were over 65 years of age. Reports were mainly
submitted by health-care professionals. Most of the reports came from
the US, Japan and France, with the exception of those whose origin could
not be identified. All the clinical characteristics of these patients
with cardiac AEs were presented in Table 3.