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 AEs91 (82.0)93 (83.8)
Treatment-related grade ≥3 AEs10 (9.0)11 (9.9)
Treatment-related serious AEs8 (7.2)9 (8.1)
Treatment-related fatal AEs00
Treatment-emergent fatal AEs3 (2.7)4 (3.6)
Primary analysisLonger-term analysis
Most frequent treatment-related AEsAny 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)
 Fever53 (47.7)5 (4.5)53 (47.7)5 (4.5)
 Chills29 (26.1)29 (26.1)
 Influenza-like illness25 (22.5)26 (23.4)
 Nausea18 (16.2)18 (16.2)
 Fatigue17 (15.3)18 (16.2)
 Injection-site pain17 (15.3)1 (0.9)17 (15.3)1 (0.9)
 Headache16 (14.4)16 (14.4)
 Asthenia10 (9.0)11 (9.9)
 Arthralgia9 (8.1)9 (8.1)
 Vomiting8 (7.2)8 (7.2)
 Pain in extremity7 (6.3)2 (1.8)7 (6.3)2 (1.8)
 Diarrhea6 (5.4)
 Cytokine release syndrome1 (0.9)1 (0.9)
 Tumor hemorrhage1 (0.9)1 (0.9)
 Neurofibrosarcoma1 (0.9)1 (0.9)
 Anemia1 (0.9)
  • AE, adverse event.