Table 3.
Adverse Events of Any Grade That Occurred during Treatment in 10% or More of Patients or Adverse Events of Grade 3 or Higher That Occurred in 5% or More of Patients in the Overall Population of 873 Patients.
| Variable | Avelumab plus Axitinib (N = 434) |
Sunitinib (N = 439) |
||
|---|---|---|---|---|
| All Grades | Grade ≥3 | All Grades | Grade ≥3 | |
| number of patients (percent) | ||||
| Patients with any events | 432 (99.5) | 309 (71.2) | 436 (99.3) | 314 (71.5) |
| Diarrhea | 270 (62.2) | 29 (6.7) | 209 (47.6) | 12 (2.7) |
| Hypertension | 215 (49.5) | 111 (25.6) | 158 (36.0) | 75 (17.1) |
| Fatigue | 180 (41.5) | 15 (3.5) | 176 (40.1) | 16 (3.6) |
| Nausea | 148 (34.1) | 6 (1.4) | 172 (39.2) | 7 (1.6) |
| Palmar–plantar erythrodysesthesia syndrome | 145 (33.4) | 25 (5.8) | 148 (33.7) | 19 (4.3) |
| Dysphonia | 133 (30.6) | 2 (0.5) | 14 (3.2) | 0 |
| Decreased appetite | 114 (26.3) | 9 (2.1) | 126 (28.7) | 4 (0.9) |
| Hypothyroidism | 108 (24.9) | 1 (0.2) | 61 (13.9) | 1 (0.2) |
| Stomatitis | 102 (23.5) | 8 (1.8) | 103 (23.5) | 4 (0.9) |
| Cough | 100 (23.0) | 1 (0.2) | 83 (18.9) | 0 |
| Headache | 89 (20.5) | 1 (0.2) | 71 (16.2) | 1 (0.2) |
| Dyspnea | 86 (19.8) | 13 (3.0) | 57 (13.0) | 7 (1.6) |
| Arthralgia | 85 (19.6) | 4 (0.9) | 50 (11.4) | 2 (0.5) |
| Decreased weight | 85 (19.6) | 12 (2.8) | 30 (6.8) | 4 (0.9) |
| Vomiting | 80 (18.4) | 4 (0.9) | 87 (19.8) | 7 (1.6) |
| Back pain | 77 (17.7) | 2 (0.5) | 65 (14.8) | 8 (1.8) |
| Constipation | 77 (17.7) | 0 | 64 (14.6) | 0 |
| Increased alanine aminotransferase level | 74 (17.1) | 26 (6.0) | 50 (11.4) | 11 (2.5) |
| Chills | 69 (15.9) | 1 (0.2) | 33 (7.5) | 0 |
| Asthenia | 64 (14.7) | 11 (2.5) | 72 (16.4) | 13 (3.0) |
| Increased aspartate aminotransferase level | 63 (14.5) | 17 (3.9) | 52 (11.8) | 9 (2.1) |
| Rash | 62 (14.3) | 2 (0.5) | 49 (11.2) | 2 (0.5) |
| Mucosal inflammation | 61 (14.1) | 5 (1.2) | 61 (13.9) | 5 (1.1) |
| Pruritus | 61 (14.1) | 0 | 22 (5.0) | 0 |
| Abdominal pain | 59 (13.6) | 5 (1.2) | 43 (9.8) | 8 (1.8) |
| Dysgeusia | 57 (13.1) | 0 | 142 (32.3) | 0 |
| Pyrexia | 56 (12.9) | 0 | 62 (14.1) | 1 (0.2) |
| Infusion-related reaction | 53 (12.2) | 7 (1.6) | 0 | 0 |
| Pain in extremity | 52 (12.0) | 1 (0.2) | 46 (10.5) | 3 (0.7) |
| Dizziness | 51 (11.8) | 2 (0.5) | 47 (10.7) | 3 (0.7) |
| Oropharyngeal pain | 44 (10.1) | 0 | 27 (6.2) | 0 |
| Dry skin | 43 (9.9) | 0 | 44 (10.0) | 0 |
| Edema, peripheral | 39 (9.0) | 2 (0.5) | 45 (10.3) | 1 (0.2) |
| Epistaxis | 37 (8.5) | 0 | 49 (11.2) | 0 |
| Dyspepsia | 35 (8.1) | 0 | 83 (18.9) | 0 |
| Anemia | 26 (6.0) | 7 (1.6) | 101 (23.0) | 36 (8.2) |
| Thrombocytopenia | 15 (3.5) | 1 (0.2) | 85 (19.4) | 27 (6.2) |
| Decreased platelet count | 8 (1.8) | 0 | 63 (14.4) | 22 (5.0) |
| Neutropenia | 6 (1.4) | 1 (0.2) | 83 (18.9) | 35 (8.0) |
| Decreased neutrophil count | 1 (0.2) | 0 | 45 (10.3) | 25 (5.7) |