Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial

Table 7 Incidence of psychiatric events ^a (SAS)

AE ^a	PLA-DON10	DON5-DON10	DON10-DON10	DON-DON10 ^b
AE ^a	( 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.

ISSN: 1758-9193