Table 3.
Treatment-emergent adverse events occurring in ≥1% of patients
| Placebo (N = 392) | PIM 34 mg (N = 392) | |||
| Patients, n (%) | Events, n | Patients, n (%) | Events, n | |
| Urinary tract infection | 16 (4.1) | 16 | 25 (6.4) | 26 |
| Headache | 15 (3.8) | 17 | 8 (2.0) | 10 |
| Anxiety | 5 (1.3) | 5 | 7 (1.8) | 8 |
| Blood creatine phosphokinase increased | 4 (1.0) | 4 | 5 (1.3) | 5 |
| Dizziness | 3 (0.8) | 6 | 6 (1.5) | 8 |
| Nausea | 3 (0.8) | 3 | 6 (1.5) | 6 |
| Tremor | 5 (1.3) | 5 | 4 (1.0) | 4 |
| Electrocardiogram QT prolonged | 3 (0.8) | 3 | 5 (1.3) | 5 |
| Fall | 1 (0.3) | 1 | 4 (1.0) | 4 |
| Hypertension | – | – | 5 (1.3) | 5 |
Adverse events were coded using MedDRA version 23.0. N was used as the denominator for calculating percentages within each treatment group for the subject counts. A TEAE was an adverse event with onset date on or after the first study dose date and no later than the last study dose date + 30 days. Subjects may have had more than one TEAE per category. In the “Events” column, all occurrences of TEAEs were counted per category. PIM, pimavanserin.