Table 2.
Summary of treatment-emergent adverse events
| Placebo (N = 392) | PIM 34 mg (N = 392) | Total (N = 784) | ||||
| Patients, n (%) | Events, n | Patients, n (%) | Events, n | Patients, n (%) | Events, n | |
| Any TEAE | 115 (29.3) | 205 | 119 (30.4) | 220 | 234 (29.8) | 425 |
| Any related TEAEa | 30 (7.7) | 50 | 30 (7.7) | 49 | 60 (7.7) | 99 |
| Any serious TEAE | 6 (1.5) | 9 | 8 (2.0) | 11 | 14 (1.8) | 20 |
| Any related serious TEAEa | – | – | – | – | – | – |
| Any TEAE leading to study drug discontinuation or study termination | 9 (2.3) | 9 | 10 (2.6) | 10 | 19 (2.4) | 19 |
| Any TEAE resulting in deathb | 2 (0.5) | 2 | 2 (0.5) | 2 | 4 (0.5) | 4 |
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. aEvents with missing relationship were considered related. bIncluded deaths that occurred within 30 days of last dose of study drug. PIM, pimavanserin; TEAE, treatment-emergent adverse event.