Table 3.
Selected Treatment-Related Adverse Events
| Adverse Events | Dose Level 1(n = 20) |
Dose Level 2(n = 44) |
Dose Level 3(n = 3) |
|||
|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | |
| Nonhematologic events | ||||||
| Diarrhea | ||||||
| Grade 1 | 1 | 5 | 7 | 16 | 1 | 33 |
| Grade 2 | 1 | 5 | 6 | 14 | 0 | |
| Grade 3 | 3 | 15 | 1 | 2 | 0 | |
| Grade 4 | 0 | 0 | 0 | |||
| Fatigue | ||||||
| Grade 1 | 4 | 20 | 10 | 23 | 0 | |
| Grade 2 | 9 | 45 | 13 | 30 | 1 | 33 |
| Grade 3 | 1 | 5 | 12 | 27 | 1 | 33 |
| Grade 4 | 0 | 0 | 0 | |||
| Nausea | ||||||
| Grade 1 | 7 | 35 | 11 | 25 | 1 | 33 |
| Grade 2 | 2 | 10 | 9 | 20 | 1 | 33 |
| Grade 3 | 0 | 1 | 2 | 0 | ||
| Grade 4 | 0 | 0 | 0 | |||
| Sensory neuropathy | ||||||
| Grade 1 | 5 | 25 | 15 | 34 | 0 | |
| Grade 2 | 1 | 5 | 9 | 20 | 2 | 67 |
| Grade 3 | 1 | 5 | 9 | 20 | 0 | |
| Grade 4 | 0 | 0 | 0 | |||
| Vomiting | ||||||
| Grade 1 | 1 | 5 | 10 | 23 | 1 | 33 |
| Grade 2 | 2 | 10 | 3 | 7 | 1 | 33 |
| Grade 3 | 0 | 3 | 7 | 0 | ||
| Grade 4 | 0 | 0 | 0 | |||
| Hematologic events | ||||||
| Anemia | ||||||
| Grade 1 | 7 | 35 | 10 | 23 | 2 | 67 |
| Grade 2 | 11 | 55 | 27 | 63 | 1 | 33 |
| Grade 3 | 1 | 5 | 6 | 14 | 0 | |
| Grade 4 | 0 | 0 | 0 | |||
| Leukopenia | ||||||
| Grade 1 | 2 | 10 | 6 | 14 | 1 | 33 |
| Grade 2 | 12 | 60 | 9 | 21 | 1 | 33 |
| Grade 3 | 4 | 20 | 16 | 37 | 1 | 33 |
| Grade 4 | 0 | 8 | 19 | 0 | ||
| Neutropenia | ||||||
| Grade 1 | 4 | 20 | 6 | 14 | 0 | |
| Grade 2 | 3 | 15 | 1 | 2 | 1 | 33 |
| Grade 3 | 8 | 40 | 11 | 26 | 2 | 67 |
| Grade 4 | 2 | 10 | 21 | 49 | 0 | |
| Febrile neutropenia | ||||||
| Grade 1 | 0 | 0 | 0 | |||
| Grade 2 | 0 | 0 | 0 | |||
| Grade 3 | 1 | 5 | 1 | 2 | 0 | |
| Grade 4 | 1 | 5 | 0 | 0 | ||
| Thrombocytopenia | ||||||
| Grade 1 | 5 | 25 | 18 | 42 | 2 | 67 |
| Grade 2 | 5 | 25 | 9 | 21 | 1 | 33 |
| Grade 3 | 2 | 10 | 8 | 19 | 0 | |
| Grade 4 | 1 | 5 | 4 | 9 | 0 | |
NOTE. One patient at dose level 3 had grade 5 sepsis.