Table 4.
Adverse events (safety population)a
| Adverse event, n (%)b | Placebo (N = 41) | Pitolisant 35.6 mg (N = 40) | Pitolisant 213.6 mg (N = 40) | Phentermine HCl 60 mg (N = 39) |
|---|---|---|---|---|
| Any adverse event | 20 (48.8) | 19 (47.5) | 29 (72.5) | 32 (82.1) |
| Headache | 5 (12.2) | 6 (15.0) | 10 (25.0) | 4 (10.3) |
| Euphoric mood | 4 (9.8) | 4 (10.0) | 7 (17.5) | 16 (41.0) |
| Somnolence | 6 (14.6) | 4 (10.0) | 3 (7.5) | 3 (7.7) |
| Hypervigilance | 1 (2.4) | 3 (7.5) | 5 (12.5) | 13 (33.3) |
| Nausea | 1 (2.4) | 2 (5.0) | 4 (10.0) | 0 (0.0) |
| Dizziness | 0 (0.0) | 1 (2.5) | 4 (10.0) | 1 (2.6) |
| Feeling hot | 0 (0.0) | 0 (0.0) | 4 (10.0) | 2 (5.1) |
aOccurring in >5% of participants for either pitolisant dose.
bCoded using the Medical Dictionary for Regulatory Activities version 20.0.