Table 2.
Incidence of treatment-emergent AEs (safety analysis set)
| Parameter | T-VEC plus ipilimumab (n=95) | Ipilimumab (n=95) | ||||
| Any grade AEs | 92 (96.8) | 90 (94.7) | ||||
| Grade ≥3 AEs | 44 (46.3) | 41 (43.2) | ||||
| Grade ≥4 AEs | 6 (6.3) | 4 (4.2) | ||||
| Serious AEs | 34 (35.8) | 34 (35.8) | ||||
| Fatal AEs | 5 (5.3) | 1 (1.1) | ||||
| AEs leading to discontinuation of T-VEC | 6 (6.3) | NA | ||||
| AEs leading to discontinuation of ipilimumab | 13 (13.7) | 17 (17.9) | ||||
| Any grade AEs occurring in ≥10% of patients in either arm | Any grade | Grade ≥3 | Any grade | Grade ≥3 | ||
| Fatigue | 56 (58.9) | 1 (1.1) | 40 (42.1) | 3 (3.2) | ||
| Chills | 50 (52.6) | 0 | 4 (4.2) | 0 | ||
| Diarrhea | 40 (42.1) | 3 (3.2) | 35 (36.8) | 3 (3.2) | ||
| Rash | 40 (42.1) | 1 (1.1) | 29 (30.5) | 1 (1.1) | ||
| Pruritus | 39 (41.1) | 0 | 35 (36.8) | 0 | ||
| Pyrexia | 38 (40.0) | 1 (1.1) | 9 (9.5) | 0 | ||
| Nausea | 37 (38.9) | 2 (2.1) | 26 (27.4) | 0 | ||
| Headache | 34 (35.8) | 0 | 22 (23.2) | 1 (1.1) | ||
| Influenza-like illness | 29 (30.5) | 4 (4.2) | 1 (1.1) | 0 | ||
| Injection site pain | 27 (28.4) | 0 | 0 | 0 | ||
| Arthralgia | 21 (22.1) | 0 | 16 (16.8) | 1 (1.1) | ||
| Cough | 21 (22.1) | 0 | 11 (11.6) | 0 | ||
| Vomiting | 19 (20.0) | 0 | 13 (13.7) | 0 | ||
| Abdominal pain | 16 (16.8) | 1 (1.1) | 12 (12.6) | 1 (1.1) | ||
| Injection site reaction | 15 (15.8) | 0 | ||||
| Constipation | 14 (14.7) | 0 | 9 (9.5) | 1 (1.1) | ||
| Edema peripheral | 14 (14.7) | 1 (1.1) | 5 (5.3) | 0 | ||
| Decreased appetite | 12 (12.6) | 14 (14.7) | ||||
| Anemia | 11 (11.6) | 2 (2.1) | 6 (6.3) | 1 (1.1) | ||
| Back pain | 11 (11.6) | 2 (2.1) | 8 (8.4) | 2 (2.1) | ||
| Dizziness | 11 (11.6) | 4 (4.2) | ||||
| Pain | 11 (11.6) | 1 (1.1) | 4 (4.2) | 1 (1.1) | ||
| Insomnia | 10 (10.5) | 16 (16.8) | ||||
| Lymphopenia | 10 (10.5) | 4 (4.2) | 3 (3.2) | 2 (2.1) | ||
| Myalgia | 10 (10.5) | 4 (4.2) | ||||
| Dyspnea | 9 (9.5) | 3 (3.2) | 10 (10.5) | 1 (1.1) | ||
| Asthenia | 8 (8.4) | 2 (2.1) | 10 (10.5) | 0 | ||
| Colitis | 8 (8.4) | 5 (5.3) | 14 (14.7) | 7 (7.4) | ||
Data presented as number (%) of patients.
Safety analysis set included all patients who received ≥1 dose of T-VEC or ipilimumab. Treatment-emergent AEs were defined as any AE occurring after initiation of the first dose of any study treatment through 30 days after the last administration of T-VEC or 60 days after the last dose of ipilimumab, whichever occurred later.
If a patient had multiple AEs of the same PT, the one with the worst grade is presented.
AE, adverse event; NA, not applicable; PT, preferred term; T-VEC, talimogene laherparepvec.