Table 3. Treatment-related adverse events occurring in ≥ 10% of patients in ITT population (N=60).
| Adverse event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | No. | % | No. | % | |
| Hematologic | ||||||||||
| Anemia | 19 | 31.7 | 19 | 31.7 | 4 | 6.7 | 0 | 0 | 42 | 70.0 |
| Leukopenia/Neutropenia | 14 | 23.3 | 18 | 30.0 | 14 | 23.3 | 7 | 11.7 | 53 | 88.3 |
| Thrombocytopenia | 13 | 21.7 | 3 | 5.0 | 0 | 0 | 0 | 0 | 16 | 26.7 |
| Nonhematologic | ||||||||||
| Fatigue | 8 | 13.3 | 4 | 6.7 | 5 | 8.3 | 0 | 0 | 17 | 28.3 |
| Diarrhea | 3 | 5.0 | 2 | 3.3 | 1 | 1.7 | 0 | 0 | 6 | 10.0 |
| AST/ALT elevated | 12 | 20.0 | 3 | 5.0 | 0 | 0 | 0 | 0 | 15 | 25.0 |
| Nausea/ Vomiting | 35 | 58.3 | 6 | 10.0 | 2 | 3.3 | 0 | 0 | 43 | 71.7 |
| Hand-foot syndrome | 9 | 15.0 | 4 | 6.7 | 0 | 0 | 0 | 0 | 13 | 21.7 |
| Mucositis | 6 | 10.0 | 1 | 1.7 | 2 | 3.3 | 0 | 0 | 9 | 15.0 |
| Sensory neuropathy | 22 | 36.7 | 22 | 36.7 | 3 | 5.0 | 0 | 0 | 47 | 78.3 |
Abbreviation: ITT, Intention-to-Treat; AST, Aspartate transaminase; ALT, Alanine transaminase.