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%)