Table 3.
Most frequent adverse events displayed according to System Organ Class and Preferred Term.
| Dose range | ||||||
|---|---|---|---|---|---|---|
| <60 mg/d | 60–120 mg/d | >120–180 mg/d | >180 mg/d | Total | ||
| System organ class | Preferred term | N = 10 | N = 15 | N = 16 | N = 16 | N = 57 |
| At least one AE | 4 (40.0%) | 4 (26.7%) | 7 (43.8%) | 6 (37.5%) | 21 (36.8%) | |
| Nervous system disorders | 2 (20.0%) | 1 (6.7%) | 1 (6.3%) | 4 (25.0%) | 8 (14.0%) | |
| Headache | 1 (10.0%) | – | 1 (6.3%) | 2 (12.5%) | 4 (7.0%) | |
| Dizziness | 1 (10.0%) | – | – | 1 (6.3%) | 2 (3.5%) | |
| Paresthesia | – | 1 (6.7%) | – | 1 (6.3%) | 2 (3.5%) | |
| Gastrointestinal disorders | – | 1 (6.7%) | 1 (6.3%) | 3 (18.8%) | 5 (8.8%) | |
| Nausea | – | – | – | 3 (18.8%) | 3 (5.3%) | |
| Vomiting | – | 1 (6.7%) | 1 (6.3%) | – | 2 (3.5%) | |
| Psychiatric disorders | 1 (10.0%) | 1 (6.7%) | 2 (12.5%) | – | 4 (7.0%) | |
| Anxiety | 1 (10.0%) | 1 (6.7%) | 2 (3.5%) | |||
| Sleep disorder | 2 (12.5%) | 2 (3.5%) | ||||