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.