Table 4.
Summary of AEs (safety analysis set)
| Incidence, n (%) | Talimogene laherparepvec (N=111) | |||
| Primary analysis (median follow-up 59 weeks) | Longer-term analysis (median follow-up 108 weeks) |
|||
| Treatment-related AEs | 91 (82.0) | 93 (83.8) | ||
| Treatment-related grade ≥3 AEs | 10 (9.0) | 11 (9.9) | ||
| Treatment-related serious AEs | 8 (7.2) | 9 (8.1) | ||
| Treatment-related fatal AEs | 0 | 0 | ||
| Treatment-emergent fatal AEs | 3 (2.7) | 4 (3.6) | ||
| Primary analysis | Longer-term analysis | |||
| Most frequent treatment-related AEs | Any grade (reported at an incidence ≥5%) | Any grade ≥3 (>1 patient affected) | Any grade (reported at an incidence ≥5%) | Any grade ≥3 (>1 patient affected) |
| Fever | 53 (47.7) | 5 (4.5) | 53 (47.7) | 5 (4.5) |
| Chills | 29 (26.1) | – | 29 (26.1) | – |
| Influenza-like illness | 25 (22.5) | – | 26 (23.4) | – |
| Nausea | 18 (16.2) | – | 18 (16.2) | – |
| Fatigue | 17 (15.3) | – | 18 (16.2) | – |
| Injection-site pain | 17 (15.3) | 1 (0.9) | 17 (15.3) | 1 (0.9) |
| Headache | 16 (14.4) | – | 16 (14.4) | – |
| Asthenia | 10 (9.0) | – | 11 (9.9) | – |
| Arthralgia | 9 (8.1) | – | 9 (8.1) | – |
| Vomiting | 8 (7.2) | – | 8 (7.2) | – |
| Pain in extremity | 7 (6.3) | 2 (1.8) | 7 (6.3) | 2 (1.8) |
| Diarrhea | – | – | 6 (5.4) | – |
| Cytokine release syndrome | – | 1 (0.9) | – | 1 (0.9) |
| Tumor hemorrhage | – | 1 (0.9) | – | 1 (0.9) |
| Neurofibrosarcoma | – | 1 (0.9) | – | 1 (0.9) |
| Anemia | – | – | – | 1 (0.9) |
AE, adverse event.