Adverse event profile of crizotinib in real-world from the FAERS database: a 12-year pharmacovigilance study

Table 2 Basic information of reports with crizotinib on AEs from the FAERS database

Characteristics	Case number, n	Case proportion, %
Number of events	10,226
Gender
Female	5045	49.34
Male	4071	39.81
Unknown	1110	10.85
Age
<18	200	1.96
18 ~ 45	963	9.42
45 ~ 65	3084	30.16
65 ~ 75	2010	19.66
>=75	1440	14.08
Unknown	2529	24.73
Reporter
Physician	3731	36.49
Consumer	3327	32.53
Other health-professional	1597	15.62
Pharmacist	1463	14.31
Unknown	108	1.06
Reported countries
United States	5236	51.20
other	1294	12.65
India	800	7.82
Japan	785	7.68
China	389	3.80
France	361	3.53
Canada	192	1.88
United Kingdom	182	1.78
Argentina	165	1.61
Germany	131	1.28
Italy	117	1.14
Korea, South	112	1.10
Colombia	82	0.80
Australia	81	0.79
Taiwan	65	0.64
Netherlands	62	0.61
Thailand	62	0.61
Turkey	59	0.58
Brazil	51	0.50
Report year
2011	76	0.74
2012	620	6.06
2013	976	9.54
2014	1179	11.53
2015	1108	10.84
2016	1083	10.59
2017	879	8.60
2018	861	8.42
2019	911	8.91
2020	721	7.05
2021	645	6.31
2022	574	5.61
2023	593	5.80
Severe outcomes
Death	3347	37.80
Other serious	2877	32.49
Hospitalization	2296	25.93
Life threatening	250	2.82
Disability	79	0.89
Required intervention to prevent permanent impairment/damage	5	0.06
Time to onset (days)
< 7	487	7.57
7 ~ 28	665	10.33
28 ~ 56	423	6.57
>=56	1219	18.94
Unknown	3643	56.59

ISSN: 2050-6511