Table 5.
Treatment-Related Adverse Events
| Adverse Event* | Any Grade | Grade 1–2 | Grade 3–4 |
|---|---|---|---|
| Neutropenia | 35 (36.1%) | 30 (30.9%) | 5 (5.2%) |
| Anemia | 13 (13.4%) | 11 (11.3%) | 2 (2.1%) |
| Thrombocytopenia | 43 (44.3%) | 36 (37.1%) | 7 (7.2%) |
| Fatigue | 43 (44.3%) | 40 (41.2%) | 3 (3.1%) |
| Hypertension | 52 (53.6%) | 43 (44.3%) | 9 (9.3%) |
| Weight loss | 38 (39.2%) | 36 (37.1%) | 2 (2.1%) |
| Hypothyroidism | 36 (37.1%) | 33 (34.0%) | 3 (3.1%) |
| Hand foot skin reaction | 10 (10.3%) | 9 (9.3%) | 1 (1.0%) |
| Rash | 18 (18.6%) | 13 (13.4%) | 5 (5.2%) |
| Vomiting | 30 (30.9%) | 25 (25.7%) | 5 (5.2%) |
| Diarrhea | 32 (33.0%) | 28 (28.9%) | 4 (4.1%) |
| Abdominal pain | 42 (43.3%) | 41 (42.3%) | 1 (1.0%) |
| Proteinuria | 29 (29.9%) | 24 (24.8%) | 5 (5.1%) |
| Elevated ALT | 62 (63.9%) | 55 (56.7%) | 7 (7.2%) |
| Elevated AST | 65 (67.0%) | 57 (58.8%) | 8 (8.2%) |
| Hyperbilirubinemia | 23 (23.7%) | 18 (18.6%) | 5 (5.1%) |
| Hypoalbuminemia | 28 (28.9%) | 25 (25.8%) | 3 (3.1%) |
| Sensory neuropathy | 11 (11.3%) | 11 (11.3%) | 0 |
| Decreased appetite | 27 (27.8%) | 24 (24.7%) | 3 (3.1%) |
| Elevated creatinine | 18 (18.6%) | 14 (14.5%) | 4 (4.1%) |
| Immune-related hepatitis | 4 (4.1%) | 2 (2.1%) | 1 (1.0%) |
| Immune-related pneumonitis | 2 (2.1%) | 0 | 2 (2.1%) |
| Immune-related dermatitis | 8 (8.2%) | 7 (7.2%) | 2 (1.0%) |
Note: *Listed are adverse events, as defined by the National Cancer Institute Common Terminology Criteria (version 4.03).