Table 2.
Treatment-Related Adverse Events Occurring in Greater Than or Equal to 10% of Patients
|
Adverse Event |
No. (%) of Patients With Treatment-Related Adverse Event by Gradea |
|||
|---|---|---|---|---|
| All Grades | Grade 1 | Grade 2 | Grade 3 | |
| Hypercholesterolemia | 16 (100) | 8 (50) | 7 (44) | 1 (6) |
| Hypertriglyceridemia | 12 (75) | 7 (44) | 4 (25) | 1 (6) |
| Cognitive effects | 10 (63) | 9 (56) | 1 (6) | 0 (0) |
| Peripheral edema | 10 (63) | 7 (44) | 3 (19) | 0 (0) |
| AST elevation | 9 (56) | 9 (56) | 0 (0) | 0 (0) |
| ALT elevation | 9 (56) | 9 (56) | 0 (0) | 0 (0) |
| Peripheral neuropathy | 9 (56) | 7 (44) | 1 (6) | 0 (0) |
| Weight gain | 6 (38) | 4 (25) | 1 (6) | 1 (6) |
| Mood effects | 5 (31) | 4 (25) | 1 (6) | 0 (0) |
| Polyphagia | 4 (25) | 4 (25) | 0 (0) | 0 (0) |
| Myalgia | 4 (25) | 4 (25) | 0 (0) | 0 (0) |
| Arthralgia | 3 (19) | 3 (19) | 0 (0) | 0 (0) |
| Lipase elevation | 3 (19) | 0 (0) | 0 (0) | 3 (19) |
| Amylase elevation | 2 (13) | 2 (13) | 0 (0) | 0 (0) |
| Median nerve neuropathy | 2 (13) | 1 (6) | 1 (6) | 0 (0) |
| Constipation | 2 (13) | 1 (6) | 1 (6) | 0 (0) |
| Fatigue | 2 (13) | 2 (13) | 0 (0) | 0 (0) |
| Headache | 2 (13) | 2 (13) | 0 (0) | 0 (0) |
ALT, alanine transaminase; AST, aspartate transaminase.
a
No grade 4 or 5 events were observed.