Table 3.
Summary of drug-related adverse events (AEs) (equal of higher than 15% of any grade in either treatment group)—intermediate/poor-risk subjects and all treated subjects
| Intermediate/poor-risk subjects | All treated subjects | |||||||
| Nivolumab+ipilimumab (N =423) |
Sunitinib (N=416) |
Nivolumab+ipilimumab (N=547) |
Sunitinib (N=535) |
|||||
| Any grade | Grade 3–4 | Any grade | Grade 3–4 | Any grade | Grade 3–4 | Any grade | Grade 3–4 | |
| Drug-related AEs, N (%) | 388 (91.7) | 190 (44.9) | 403 (96.9) | 254 (61.1) | 509 (93.1) | 250 (45.7) | 521 (97.4) | 335 (62.6) |
| Most frequent drug-related AEs (≥15% of any grade in either treatment group) | ||||||||
| Fatigue | 140 (33.1) | 16 (3.8) | 183 (44.0) | 34 (8.2) | 202 (36.9) | 23 (4.2) | 264 (49.3) | 49 (9.2) |
| Asthenia | 55 (13.0) | 6 (1.4) | 64 (15.4) | 10 (2.4) | 72 (13.2) | 8 (1.5) | 91 (17.0) | 12 (2.2) |
| Mucosal inflammation | 11 (2.6) | 0 | 113 (27.2) | 11 (2.6) | 13 (2.4) | 0 | 152 (28.4) | 14 (2.6) |
| Pruritus | 122 (28.8) | 3 (0.7) | 35 (8.4) | 0 | 154 (28.2) | 3 (0.5) | 49 (9.2) | 0 |
| Rash | 84 (19.9) | 8 (1.9) | 47 (11.3) | 0 | 118 (21.6) | 8 (1.5) | 67 (12.5) | 0 |
| Palmar-plantar | 2 (0.5) | 0 | 162 (38.9) | 32 (7.7) | 5 (0.9) | 0 | 231 (43.2) | 49 (9.2) |
| Erythrodysaesthesia syndrome | ||||||||
| Diarrhoea | 102 (24.1) | 15 (3.5) | 199 (47.8) | 19 (4.6) | 145 (26.5) | 21 (3.8) | 278 (52.0) | 28 (5.2) |
| Nausea | 78 (18.4) | 6 (1.4) | 142 (34.1) | 5 (1.2) | 109 (19.9) | 8 (1.5) | 202 (37.8) | 6 (1.1) |
| Vomiting | 42 (9.9) | 3 (0.7) | 88 (21.2) | 9 (2.2) | 59 (10.8) | 4 (0.7) | 110 (20.6) | 10 (1.9) |
| Stomatitis | 14 (3.3) | 0 | 100 (24.0) | 12 (2.9) | 23 (4.2) | 0 | 149 (27.9) | 14 (2.6) |
| Dyspepsia | 8 (1.9) | 0 | 66 (15.9) | 0 | 15 (2.7) | 0 | 96 (17.9) | 0 |
| Lipase increased | 67 (15.8) | 40 (9.5) | 43 (10.3) | 26 (6.3) | 90 (16.5) | 56 (10.2) | 58 (10.8) | 35 (6.5) |
| Decreased appetite | 55 (13.0) | 4 (0.9) | 102 (24.5) | 4 (1.0) | 75 (13.7) | 7 (1.3) | 133 (24.9) | 5 (0.9) |
| Hypothyroidism | 65 (15.4) | 2 (0.5) | 97 (23.3) | 1 (0.2) | 85 (15.5) | 2 (0.4) | 134 (25.0) | 1 (0.2) |
| Dysgeusia | 24 (5.7) | 0 | 128 (30.8) | 1 (0.2) | 31 (5.7) | 0 | 179 (33.5) | 1 (0.2) |
| Anaemia | 27 (6.4) | 2 (0.5) | 75 (18.0) | 22 (5.3) | 34 (6.2) | 2 (0.4) | 83 (15.5) | 24 (4.5) |
| Hypertension | 7 (1.7) | 1 (0.2) | 151 (36.3) | 60 (14.4) | 12 (2.2) | 4 (0.7) | 216 (40.4) | 85 (15.9) |
| Thrombocytopenia | 2 (0.5) | 0 | 69 (16.6) | 19 (4.6) | 2 (0.4) | 0 | 95 (17.8) | 25 (4.7) |