Table 1.
Patient demographics of AEs related to T-VEC in the FAERS database
| Characteristic | Case N (%) |
|---|---|
| Total | 1138 |
| Sex | |
| Female | 373(32.8%) |
| Male | 401(35.2%) |
| Unknown | 364(32.0%) |
| Reporting country | |
| USA | 894(78.6%) |
| Rest of the world | 243(21.3%) |
| Unknown | 1(0.1%) |
| Reporting year | |
| 2023 quarter 1 to 2023 quarter 3 | 71(6.2%) |
| 2022 | 116(10.2%) |
| 2021 | 115(10.1%) |
| 2020 | 131(11.5%) |
| 2019 | 151(13.3%) |
| 2018 | 183(16.1%) |
| 2017 | 194(17.0%) |
| 2016 | 176(15.5%) |
| 2015 and before | 1(0.1%) |
| Age at onset | |
| < 18 years | 3(0.3%) |
| 18 ~ 44 years | 54(4.5%) |
| 45 ~ 59 years | 167(14.7%) |
| ≥ 60 years | 391(34.4%) |
| Unknown | 523(46.0%) |
| Outcome | |
| Death | 116(10.2%) |
| Life-threatening | 23(2.0%) |
| Hospitalization | 234(20.6%) |
| Disability | 11(1.0%) |
| Other serious events | 437(38.4%) |
| Unknown | 317(27.9%) |