Table 4.
Treatment Related Adverse Events* (n=46).
| Grade 1-2 | Grade 3 | Grade 4 | |
|---|---|---|---|
| Neutropenia | 14 (30.4%) | 7 (15.2%) | 3 (6.5%) |
| Thrombocytopenia | 15 (32.6%) | 5 (10.9%) | 3 (6.5%) |
| Nausea | 19 (41.3%) | 4 (8.7%) | 0 |
| Abdominal pain | 20 (43.5%) | 2 (4.3%) | 0 |
| Vomit | 17 (37.0%) | 3 (6.5%) | 0 |
| Fatigue | 17 (37.0%) | 2 (4.3%) | 0 |
| Aspartate aminotransferase increased | 12 (26.1%) | 6 (13.0%) | 0 |
| Alanine aminotransferase increased | 10 (21.7%) | 4 (8.7%) | 0 |
| Hypertension | 13 (28.3%) | 0 | 0 |
| Edema | 10 (21.7%) | 2 (4.3%) | 0 |
| Diarrhea | 8 (17.4%) | 1 (2.2%) | 0 |
| Ascites | 6 (13.0%) | 1 (2.2%) | 0 |
| Fever | 6 (13.0%) | 0 | 0 |
| Pruritus | 6 (13.0%) | 0 | 0 |
| Hand-foot skin reaction | 5 (10.9%) | 1 (2.2%) | 0 |
| Infection | 4 (8.7%) | 0 | 1 (2.2%) |
| Anemia | 3 (6.5%) | 1 (2.2%) | 0 |
| Gastrointestinal bleeding | 2 (4.3%) | 1 (2.2%) | 0 |
| Immune-related adverse event | |||
| Immune-related hypothyroidism | 6 (13.0%) | 1 (2.2%) | 0 |
| Immune-related dermatitis | 3 (6.5%) | 0 | 0 |
| Immune-related hepatitis | 3 (6.5%) | 0 | 0 |
*Listed are adverse events, as defined by the National Cancer Institute Common Terminology Criteria (version 4.03), that occurred in at least 5% of patients.