Table 2.
Treatment-related adverse events
| Preferred Term | Maximum CTCAE Toxicity Grade, n (%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 500 mg b.i.d. (N = 3) | 750 mg b.i.d. (N = 4) | 1000 mg b.i.d. (N = 6) | |||||||
| 3 | 4 | Any Grade | 3 | 4 | Any Grade | 3 | 4 | Any Grade | |
| Any event | 1 (33) | 0 | 3 (100) | 1 (25) | 1 (25) | 4 (100) | 2 (33) | 1 (17) | 6 (100) |
| Diarrhea | 0 | 0 | 0 | 1 (25) | 0 | 3 (75) | 0 | 0 | 2 (33) |
| Fatigue | 0 | 0 | 1 (33) | 1 (25) | 0 | 1 (25) | 1 (17) | 0 | 2 (33) |
| Nausea | 0 | 0 | 1 (33) | 0 | 0 | 2 (50) | 0 | 0 | 1 (17) |
| Blood bilirubin increased | 0 | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 | 2 (33) |
| Somnolence | 0 | 0 | 0 | 1 (25) | 0 | 1 (25) | 1 (17) | 0 | 2 (33) |
| Cerebral edema | 0 | 0 | 0 | 0 | 1 (25) | 1 (25) | 0 | 1 (17) | 1 (17) |
| Hypercholesterolemia | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 1 (17) |
| Vomiting | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 1 (17) |
| ALT increased | 1 (33) | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 | 0 |
| Aphasia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 1 (17) |
| AST increased | 0 | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 | 0 |
| Asthenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) |
| Blood cholesterol increased | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 0 |
| Headache | 0 | 0 | 0 | 1 (25) | 0 | 1 (25) | 0 | 0 | 0 |
| Hypokalemia | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 0 |
| Fall | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) |
| Lower respiratory tract infection | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 1 (17) |
| Lymphopenia | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 0 |
| Muscular weakness | 0 | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 | 0 |
| Myalgia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 1 (17) |
| Myoclonus | 0 | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 | 0 |
| Oropharyngeal pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) |
| Seizure | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 0 |
ALT = alanine aminotransferase; AST = aspartate aminotransferase.