Table 2. Treatment-Related Adverse Events in the Safety Analysis Set.
| Event | Treatment Group | All Patients (N = 263) | ||
|---|---|---|---|---|
| Durvalumab + Tremelimumab (n = 133) | Durvalumab (n = 65) | Tremelimumab (n = 65) | ||
| All-grade TRAEs, No. (%)a | 77 (57.9) | 41 (63.1) | 36 (55.4) | 154 (58.6) |
| Diarrhea | 19 (14.3) | 7 (10.8) | 10 (15.4) | 36 (13.7) |
| Asthenia | 13 (9.8) | 5 (7.7) | 4 (6.2) | 22 (8.4) |
| Hypothyroidism | 11 (8.3) | 7 (10.8) | 1 (1.5) | 19 (7.2) |
| Decreased appetite | 11 (8.3) | 2 (3.1) | 3 (4.6) | 16 (6.1) |
| Rash | 9 (6.8) | 1 (1.5) | 5 (7.7) | 15 (5.7) |
| Fatigue | 8 (6.0) | 12 (18.5) | 4 (6.2) | 24 (9.1) |
| Anemia | 8 (6.0) | 1 (1.5) | 0 | 9 (3.4) |
| Nausea | 7 (5.3) | 1 (1.5) | 5 (7.7) | 13 (4.9) |
| Pyrexia | 6 (4.5) | 0 | 4 (6.2) | 10 (3.8) |
| Pruritus | 5 (3.8) | 5 (7.7) | 3 (4.6) | 13 (4.9) |
| Vomiting | 2 (1.5) | 1 (1.5) | 5 (7.7) | 8 (3.0) |
| Grade 3/4 TRAEs, No. (%)b | 21 (15.8) | 8 (12.3) | 11 (16.9) | 40 (15.2) |
| Diarrhea | 4 (3.0) | 0 | 3 (4.6) | 7 (2.7) |
| Anemia | 3 (2.3) | 0 | 0 | 3 (1.1) |
| Asthenia | 3 (2.3) | 0 | 0 | 3 (1.1) |
| Fatigue | 1 (0.8) | 2 (3.1) | 1 (1.5) | 4 (1.5) |
| Treatment-related SAE, No. (%) | 17 (12.8) | 1 (1.5) | 8 (12.3) | 26 (9.9) |
| Treatment-related AESI, No. (%) | 47 (35.3) | 23 (35.4) | 20 (30.8) | 90 (34.2) |
| Treatment-related imAE, No. (%) | 26 (19.5) | 5 (7.7) | 0 (0.0) | 31 (11.8) |
| Grade 3/4 treatment-related imAE, No. (%) | 8 (6.0) | 0 (0.0) | 0 (0.0) | 8 (3.0) |
| TRAE leading to dose interruption, No. (%) | 11 (8.3) | 4 (6.2) | 6 (9.2) | 21 (8.0) |
| TRAE leading to dose discontinuation, No. (%) | 7 (5.3) | 0 | 5 (7.7) | 12 (4.6) |
| TRAE leading to death, No. (%) | 1 (0.8)c | 0 | 0 | 1 (0.4) |
Abbreviations: AESI, adverse event of special interest; imAE, immune-mediated adverse event; SAE, serious adverse event; SAS, safety analysis set; TRAEs, treatment-related adverse events.
a
Individual adverse events with incidence greater than 5% in any arm are reported.
b
Individual grade 3/4 adverse events with incidence greater than 2% in any arm are reported.
c
Grade 3 acute respiratory failure.