Table 2.
Treatment-related adverse events (AEs) that occurred in ≥ 20% in either treatment arm
| Treatment-related AE | Pembrolizumab-axitinib (n = 44) | Sunitinib (n = 49) | ||||
|---|---|---|---|---|---|---|
| Any grade | Grade 1/2 | Grade 3/4 | Any grade | Grade 1/2 | Grade 3/4 | |
| Any | 44 (100.0) | 13 (29.5) | 31 (70.5) | 49 (100.0) | 11 (22.4) | 38 (77.6) |
| Palmar–plantar erythrodysesthesia | 26 (59.1) | 24 (54.5) | 2 (4.5) | 39 (79.6) | 35 (71.4) | 4 (8.2) |
| Hypertension | 23 (52.3) | 17 (38.6) | 6 (13.6) | 25 (51.0) | 16 (32.7) | 9 (18.4) |
| Diarrhea | 22 (50.0) | 16 (36.4) | 6 (13.6) | 17 (34.7) | 13 (26.5) | 4 (8.2) |
| Proteinuria | 18 (40.9) | 16 (36.4) | 2 (4.5) | 14 (28.6) | 10 (20.4) | 4 (8.2) |
| Dysphonia | 16 (36.4) | 16 (36.4) | – | 2 (4.1) | 2 (4.1) | – |
| Hypothyroidism | 15 (34.1) | 15 (34.1) | – | 21 (42.9) | 21 (42.9) | – |
| Hepatic function abnormal | 13 (29.5) | 8 (18.2) | 5 (11.4) | 5 (10.2) | 5 (10.2) | – |
| Decreased appetite | 11 (25.0) | 10 (22.7) | 1 (2.3) | 14 (28.6) | 14 (28.6) | – |
| Blood thyroid-stimulating hormone increased | 10 (22.7) | 10 (22.7) | – | 13 (26.5) | 13 (26.5) | – |
| Fatigue | 9 (20.5) | 8 (18.2) | 1 (2.3) | 17 (34.7) | 13 (26.5) | 4 (8.2) |
| Stomatitis | 9 (20.5) | 8 (18.2) | 1 (2.3) | 17 (34.7) | 17 (34.7) | – |
| Malaise | 7 (15.9) | 6 (13.6) | 1 (2.3) | 14 (28.6) | 14 (28.6) | – |
| Dysgeusia | 4 (9.1) | 4 (9.1) | – | 19 (38.8) | 19 (38.8) | – |
| Platelet count decreased | 4 (9.1) | 3 (6.8) | 1 (2.3) | 30 (61.2) | 13 (26.5) | 17 (34.7) |
| Pyrexia | 4 (9.1) | 4 (9.1) | – | 19 (38.8) | 19 (38.8) | – |
| Neutrophil count decreased | 3 (6.8) | 2 (4.5) | 1 (2.3) | 21 (42.9) | 8 (16.3) | 13 (26.5) |
| Nausea | 2 (4.5) | 2 (4.5) | – | 10 (20.4) | 10 (20.4) | – |
| Anemia | 1 (2.3) | 1 (2.3) | – | 12 (24.5) | 9 (18.4) | 3 (6.1) |
| White blood cell count decreased | 0 | – | – | 22 (44.9) | 15 (30.6) | 7 (14.3) |
Data are n (%) and are from the as-treated population
AE adverse event