Table 2. Results of Phase 3 HIMALAYA trial: safety outcome.
| Event, n (%) | STRIDE (n=388) | Durvalumab (n=388) | Sorafenib (n=374) |
|---|---|---|---|
| TRAE | 294 (75.8) | 202 (52.1) | 317 (84.8) |
| Grade 3/4 TRAE | 100 (25.8) | 50 (12.9) | 138 (36.9) |
| Serious TRAE | 68 (17.5) | 32 (8.2) | 35 (9.4) |
| TRAE leading to death | 9 (2.3)(a) | 0 | 3 (0.8)(b) |
| TRAE leading to discontinuation | 32 (8.2) | 16 (4.1) | 41 (11.0) |
| Grade 3/4 hepatic SMQ TRAE | 23 (5.9) | 20 (5.2) | 17 (4.5) |
| Grade 3/4 hemorrhage SMQ TRAE | 2 (0.5) | 0 | 4 (1.1) |
| Grade 3/4 immune-mediated TRAE | 49 (12.6) | 24 (6.2) | 9 (2.4) |
| Immune-mediate AE requiring treatment with high-dose steroids | 78 (20.1) | 37 (9.5) | 7 (1.9) |
| Immune-mediated AE leading to discontinuation of study treatment | 22 (5.7) | 10 (2.6) | 6 (1.6) |
(a), nervous system disorder (n=1), acute respiratory distress syndrome (n=1), hepatitis (n=1), myocarditis (n=1), immune-mediated hepatitis (n=2), pneumonitis (n=1), hepatic failure (n=1), myasthenia gravis (n=1); (b), hematuria (n=1), cerebral hematoma (n=1), hepatic failure (n=1). STRIDE, Single Tremelimumab Regular Interval Durvalumab; TRAE, treatment-related adverse event; SMQ, Standardized MedDRA Query.