Table 4.
Most common (incidence ≥ 2%) treatment-emergent adverse events.
| Colorectal cancer (n = 2798) | Non-colorectal cancer (n = 204) | Total (N = 3005a) | ||||
|---|---|---|---|---|---|---|
| Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 | |
| Palmar-plantar erythrodysesthesia syndrome | 578 (20.7) | 67 (2.4) | 15 (7.4) | 0 | 594 (19.8) | 67 (2.2) |
| Hypertension | 473 (16.9) | 196 (7.0) | 7 (3.4) | 1 (0.5) | 480 (16.0) | 197 (6.6) |
| Asthenia | 340 (12.2) | 19 (0.7) | 10 (4.9) | 0 | 350 (11.7) | 19 (0.6) |
| Appetite decreased | 283 (10.1) | 13 (0.5) | 11 (5.4) | 1 (0.5) | 294 (9.8) | 14 (0.5) |
| Diarrhea | 264 (9.4) | 27 (1.0) | 17 (8.3) | 2 (1.0) | 281 (9.4) | 29 (1.0) |
| Dysphonia | 252 (9.0) | 1 (0.04) | 7 (3.4) | 0 | 260 (8.7) | 1 (0.03) |
| Proteinuria | 197 (7.0) | 24 (0.9) | 2 (1.0) | 0 | 199 (6.6) | 24 (0.8) |
| Abdominal pain | 178 (6.4) | 21 (0.8) | 12 (5.9) | 2 (1.0) | 190 (6.3) | 23 (0.8) |
| Vomiting | 104 (3.7) | 8 (0.3) | 11 (5.4) | 0 | 115 (3.8) | 8 (0.3) |
| Constipation | 106 (3.8) | 0 | 4 (2.0) | 0 | 110 (3.7) | 0 |
| Oral ulcer | 96 (3.4) | 1 (0.04) | 9 (4.4) | 0 | 105 (3.5) | 1 (0.03) |
| Rash | 85 (3.0) | 5 (0.2) | 4 (2.0) | 1 (0.5) | 89 (3.0) | 6 (0.2) |
| Bloating | 86 (3.1) | 3 (0.1) | 1 (0.5) | 0 | 87 (2.9) | 3 (0.1) |
| Nausea | 80 (2.9) | 3 (0.1) | 5 (2.5) | 0 | 85 (2.8) | 3 (0.1) |
| Fever | 74 (2.6) | 4 (0.1) | 6 (2.9) | 0 | 80 (2.7) | 4 (0.1) |
| Oral mucositis | 60 (2.1) | 8 (0.3) | 6 (2.9) | 1 (0.5) | 66 (2.2) | 9 (0.3) |
| Platelet count decreased | 158 (5.7) | 28 (1.0) | 13 (6.4) | 2 (1.0) | 171 (5.7) | 30 (1.0) |
| White blood cell count decreased | 79 (2.8) | 5 (0.2) | 14 (6.9) | 1 (0.5) | 93 (3.1) | 6 (0.2) |
| Cough | 80 (2.9) | 2 (0.1) | 1 (0.5) | 0 | 81 (2.7) | 2 (0.1) |
| Back pain | 75 (2.7) | 4 (0.1) | 5 (2.5) | 1 (0.5) | 80 (2.7) | 5 (0.2) |
| Hypokalemia | 66 (2.4) | 16 (0.6) | 6 (2.9) | 1 (0.5) | 72 (2.4) | 17 (0.5) |
| Hypoalbuminemia | 69 (2.5) | 3 (0.1) | 3 (1.5) | 0 | 72 (2.4) | 3 (0.1) |
| Arthralgia | 63 (2.3) | 5 (0.2) | 3 (1.5) | 0 | 66 (2.2) | 5 (0.2) |
| Anemia | 79 (2.8) | 23 (0.8) | 7 (3.4) | 2 (1.0) | 86 (2.9) | 25 (0.8) |
| Abnormal liver function | 56 (2.0) | 7 (0.3) | 2 (1.0) | 0 | 58 (1.9) | 7 (0.2) |
| Pain in extremity | 54 (1.9) | 7 (0.3) | 2 (1.0) | 0 | 56 (1.9) | 7 (0.2) |
| Headache | 51 (1.8) | 2 (0.1) | 0 | 0 | 51 (1.7) | 2 (0.1) |
| Aspartate aminotransferase increased | 44 (1.6) | 4 (0.1) | 5 (2.5) | 0 | 49 (1.6) | 4 (0.1) |
| Edema peripheral | 46 (1.6) | 3 (0.1) | 3 (1.5) | 0 | 49 (1.6) | 3 (0.1) |
| Pain | 44 (1.6) | 1 (0.04) | 3 (1.5) | 0 | 47 (1.6) | 1 (0.03) |
| Neutrophil count decreased | 35 (1.3) | 4 (0.1) | 5 (2.5) | 1 (0.5) | 40 (1.3) | 5 (0.2) |
| Hyponatremia | 39 (1.4) | 14 (0.5) | 0 | 0 | 39 (1.3) | 14 (0.5) |
aIncluded 3 patients who had unknown primary tumors: patient 1 had an unknown origin, likely gastrointestinal tract, with lung metastasis; patient 2 had abdominal metastasis of unknown primary tumor; patient 3 had multicentric intestinal adenocarcinoma with peritoneal, lymph node, and lung metastasis.