Table 2.
Adverse Events Considered at Least Possibly Treatment Related.a
| All Grades (number of patients) | Grade 3 or 4 events (number of patients) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Adverse Event | TOTAL (N = 25) | 8 (N = 7) | 10 (N = 6) | 12 (N = 9) | 18 (N = 3) | 8 (N = 7) | 10 (N = 6) | 12 (N = 9) | 18 (N = 3) |
| Fatigue | 18 (72%) | 5 | 4 | 7 | 2 | 2 | 1 | 0 | 0 |
| Nausea | 17 (68%) | 6 | 4 | 4 | 3 | 0 | 0 | 0 | 0 |
| Alopecia | 13 (52%) | 4 | 5 | 3 | 1 | NA | NA | NA | NA |
| Diarrhea | 13 (52%) | 2 | 3 | 6 | 2 | 0 | 1 | 2 | 0 |
| Neutrophil count decreased | 14 (56%) | 1 | 2 | 8 | 3 | 1 | 1 | 5 | 2* |
| Vomiting | 10 (40%) | 3 | 1 | 4 | 2 | 0 | 0 | 0 | 0 |
| Dysgeusia | 5 (20%) | 1 | 1 | 3 | 1 | 0 | 0 | 0 | 0 |
| Abdominal pain | 4 (16%) | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
| Hypokalemia | 4 (16%) | 1 | 0 | 2 | 1 | 0 | 0 | 1 | 0 |
| Skin hyperpigmentation | 4 (16%) | 0 | 1 | 3 | 0 | 0 | 0 | 0 | 0 |
| Anemia | 3 (12%) | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 |
| Dehydration | 3 (12%) | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Hypomagnesaemia | 3 (12%) | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Pruritus | 3 (12%) | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Pyrexia | 3 (12%) | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| WBC count decreased | 3 (12%) | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
| Febrile neutropenia | 2 (8%) | 0 | 1 | 1 | 0 | 0 | 1 | 1* | 0 |
| Deep vein thrombosis | 1 (4%) | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
a
Included are drug-related events that occurred in at least 10% of patients or any drug-related grade 3 or 4 adverse events.
*
Grade 4 events.