Table 3.
Adverse events in patients from V0 to V2.
| N | |
|---|---|
| Total AEs, N | 13 |
| - Dyskinesia | 2 |
| - Nausea | 2 |
| - Unrest | 1 |
| - Visual hallucinations | 1 |
| - Insomina | 1 |
| - Vivid dreams | 1 |
| - Tiredness | 1 |
| - Insomnia | 1 |
| - OFF time increase | 1 |
| - Arthritis in both wrists | 1 |
| - Supraspinatus tendonitis | 1 |
| Patients with at least one AE, N (%) | 11 (33.3) |
| At least possibly related AEs, N | 8 |
| Patients with at least possibly* related to opicapone AEs, N (%) | 7 (21.2) |
| Total SAEs, N | 1 |
| - Arthritis in both wrists | |
| Patients with al least one SAE, N (%) | 1 (3) |
| At least possibly * related to opicapone SAEs, N | 0 |
| Patients with at least possibly related to opicapone SAEs, N (%) | 0 (0) |
| Patients with at least one AE leading to discontinuation, N (%) | 2 (6.1) |
| Patients with at least one possibly* related to opicapone AE leading to discontinuation N (%) | 2 (6.1) |
| Deaths, N (%) | 0 (0) |
* Considered “possibly”, “probably” or “definitely” related to treatment (opicapone). AE, adverse event; SAE, serious adverse event.