Table 3.
Incidence of treatment emergent adverse events
| TEAE Category | N = 495 |
|---|---|
| Any TEAE | 371 (74.9) |
| Any treatment-relateda TEAE | 223 (45.1) |
| Any serious TEAE | 34 (6.9) |
| Any treatment-relateda serious TEAE | 7 (1.4) |
| Any TEAE leading to discontinuation | 84 (17.0) |
| Any treatment-relateda TEAE leading to discontinuation | 66 (13.3) |
| Any serious TEAE leading to discontinuation | 8 (1.6) |
| Any TEAE leading to death | 1 (0.2) |
| Treatment-related TEAEs (≥2% patients) | |
| Dyskinesia | 57 (11.5) |
| Dry mouth | 32 (6.5) |
| Dizziness | 24 (4.8) |
| Nausea | 22 (4.4) |
| Constipation | 20 (4.0) |
| Insomnia | 12 (2.4) |
| Hallucination | 11 (2.2) |
| Fall | 10 (2.0) |
| TEAEs leading to discontinuation (≥1% patients) | |
| Nausea | 10 (2.0) |
| Constipation | 7 (1.4) |
| Hallucination | 6 (1.2) |
| Dizziness | 5 (1.0) |
| Dyskinesia | 5 (1.0) |
aTreatment-related TEAEs were any TEAEs that were considered at least possibly related by the investigator and include the events with missing relationship assessment