Table 7.
Incidence of psychiatric events a (SAS)
| AE a | PLA-DON10 | DON5-DON10 | DON10-DON10 | DON-DON10 b |
|---|---|---|---|---|
| ( n =37) | ( n =47) | ( n =49) | ( n =96) | |
| Subjects with any psychiatric events, n (%) | 6 (16.2) | 9 (19.1) | 9 (18.4) | 18 (18.8) |
| Irritability | 1 (2.7) | 2 (4.3) | 0 | 2 (2.1) |
| Cognitive disorder | 0 | 1 (2.1) | 0 | 1 (1.0) |
| Somnolence | 2 (5.4) | 0 | 0 | 0 |
| Affect lability | 1 (2.7) | 0 | 0 | 0 |
| Aggression | 0 | 0 | 1 (2.0) | 1 (1.0) |
| Agitation | 1 (2.7) | 3 (6.4) | 0 | 3 (3.1) |
| Anxiety | 0 | 1 (2.1) | 0 | 1 (1.0) |
| Apathy | 0 | 1 (2.1) | 0 | 1 (1.0) |
| Delirium | 0 | 0 | 1 (2.0) | 1 (1.0) |
| Depression | 0 | 1 (2.1) | 1 (2.0) | 2 (2.1) |
| Disinhibition | 0 | 1 (2.1) | 1 (2.0) | 2 (2.1) |
| Disturbance in sexual arousal | 0 | 0 | 1 (2.0) | 1 (1.0) |
| Eating disorder | 0 | 1 (2.1) | 0 | 1 (1.0) |
| Hallucination | 0 | 1 (2.1) | 2 (4.1) | 3 (3.1) |
| Hallucination, visual | 0 | 3 (6.4) | 0 | 3 (3.1) |
| Insomnia | 0 | 4 (8.5) | 2 (4.1) | 6 (6.3) |
| Paranoia | 0 | 1 (2.1) | 1 (2.0) | 2 (2.1) |
| Sleep disorder | 1 (2.7) | 1 (2.1) | 0 | 1 (1.0) |
SAS, safety analysis set; AE, adverse event.
a“Psychiatric events” included Preferred Terms (PTs) classified as the SOC “Psychiatric disorders” as well as “irritability,” “cognitive disorder,” and “somnolence.”
bDON5-DON10 and DON10-DON10 groups.