Table 1.
Summary of the most common TEAEs (any grade in ≥20%) occurring at any time during treatment with avelumab plus axitinib or sunitinib
| Avelumab + axitinib (n = 434) |
Sunitinib (n = 439) |
|||
|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Any TEAE, n (%) | 434 (100) | 352 (81.1) | 436 (99.3) | 340 (77.4) |
| Diarrhea | 304 (70.0) | 45 (10.4) | 228 (51.9) | 14 (3.2) |
| Hypertension | 228 (52.5) | 124 (28.6) | 162 (36.9) | 83 (18.9) |
| Fatigue | 201 (46.3) | 18 (4.1) | 192 (43.7) | 17 (3.9) |
| Nausea | 177 (40.8) | 8 (1.8) | 183 (41.7) | 8 (1.8) |
| PPE | 158 (36.4) | 28 (6.5) | 161 (36.7) | 19 (4.3) |
| Dysphonia | 148 (34.1) | 2 (0.5) | 20 (4.6) | 1 (0.2) |
| Cough | 142 (32.7) | 1 (0.2) | 104 (23.7) | 0 (0) |
| Decreased appetite | 137 (31.6) | 10 (2.3) | 141 (32.1) | 5 (1.1) |
| Hypothyroidism | 135 (31.1) | 3 (0.7) | 82 (18.7) | 2 (0.5) |
| Headache | 115 (26.5) | 1 (0.2) | 82 (18.7) | 2 (0.5) |
| Arthralgia | 113 (26.0) | 5 (1.2) | 67 (15.3) | 3 (0.7) |
| Stomatitis | 112 (25.8) | 8 (1.8) | 112 (25.5) | 4 (0.9) |
| Back pain | 111 (25.6) | 5 (1.2) | 84 (19.1) | 8 (1.8) |
| Dyspnea | 102 (23.5) | 12 (2.8) | 64 (14.6) | 7 (1.6) |
| Weight decreased | 101 (23.3) | 17 (3.9) | 42 (9.6) | 5 (1.1) |
| Vomiting | 97 (22.4) | 6 (1.4) | 98 (22.3) | 8 (1.8) |
| Constipation | 94 (21.7) | 0 (0) | 73 (16.6) | 0 (0) |
| Pruritus | 91 (21.0) | 0 (0) | 28 (6.4) | 0 (0) |
| ALT increased | 89 (20.5) | 30 (6.9) | 48 (10.9) | 12 (2.7) |
The table shows TEAEs regardless of treatment duration from first patient first dose to data cutoff (April 2020).
ALT, alanine aminotransferase; PPE, palmar plantar erythrodysesthesia; TEAE, treatment-emergent adverse event.