Table 1.
Basic demographic and reporting characteristics of vinorelbine-associated AEs in the FAERS and VigiBase databases.
| Item | FAERS n = 1711, (%) |
VigiBase n = 16175, (%) |
|
|---|---|---|---|
| Gender | Male | 537 (31.4) | 6076 (37.6) |
| Female | 819 (47.9) | 9205 (56.9) | |
| Unknown | 355 (20.7) | 894 (5.5) | |
| Age | <18 | 48 (2.8) | 267 (1.7) |
| 18 ~ 64 | 890 (34.5) | 8584 (53.1) | |
| ≥ 65 | 455 (26.6) | 4945 (30.6) | |
| Unknown | 618 (36.1) | 2379 (14.7) | |
| Reporting Countries | Africa | 16 (0.9) | 310 (1.9) |
| Asia | 250 (14.6) | 6131 (37.9) | |
| Europe | 791 (46.2) | 6179 (38.2) | |
| Oceania | 22 (1.3) | 157 (1.0) | |
| Americas | 273 (16.0) | 3398 (21.0) | |
| Unkown | 359 (21.0) | NA | |
| Report year | Before 2015 | 1194 (69.8) | 7388 (45.7) |
| 2016 | 77 (4.5) | 691 (4.3) | |
| 2017 | 57 (3.3) | 929 (5.7) | |
| 2018 | 80 (4.7) | 899 (5.5) | |
| 2019 | 127 (7.4) | 1118 (6.9) | |
| 2020 | 84 (4.9) | 1642 (10.1) | |
| 2021 | 17 (1.0) | 807 (5.0) | |
| 2022 | 30 (1.8) | 706 (4.4) | |
| 2023 | 38 (2.2) | 950 (5.9) | |
| 2024 | 7 (0.4) | 1045 (6.5) | |