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.