Table 3.
Safety summary.
| All patients |
|
|---|---|
| N = 60 | |
| Treatment-emergent AEs, n (%) | 60 (100·0) |
| Grade ≥ 3 | 12 (20·0) |
| Serious AEs | 13 (21·7) |
| Leading to permanent discontinuation of T-VEC | 5 (8·3) |
| AEs in ≥20% of patients, n (%) | |
| Chills | 39 (65·0) |
| Fatigue | 34 (56·7) |
| Headache | 27 (45·0) |
| Nausea | 27 (45·0) |
| Pyrexia | 24 (40·0) |
| Injection-site pain | 15 (25·0) |
| Pain | 15 (25·0) |
| Vomiting | 15 (25·0) |
| Diarrhoea | 13 (21·7) |
| Influenza-like illness | 13 (21·7) |
| Myalgia | 12 (20·0) |
| Rash | 12 (20·0) |
| T-VEC–related AEs, n (%) | 57 (95·0) |
| Grade ≥ 3 | 6 (10·0) |
| Serious AEs | 8 (13·3) |
| Leading to permanent discontinuation of T-VEC | 3 (5·0) |
Abbreviations: AE, adverse event; T-VEC, talimogene laherparepvec.