Table 4.

Incidence of Treatment-Emergent Adverse Events (All Causalities) Occurring in ≥5% of Subjects

	RCT		OLE
n	Ziprasidone 193	Placebo 90	Ziprasidone 221
Adverse event, n (%)
Somnolence	38 (19.7)	6 (6.7)	33 (14.9)
Extrapyramidal disorder	22 (11.4)	1 (1.1)	(<5)
Nausea	19 (9.8)	2 (2.2)	(<5)
Dizziness	18 (9.3)	1 (1.1)	8 (3.6)
Insomnia	18 (9.3)	13 (14.4)	(<5)
Fatigue	17 (8.8)	4 (4.4)	11 (5.0)
Headache	15 (7.8)	2 (2.2)	20 (9.0)
Tremor	15 (7.8)	1 (1.1)	14 (6.3)
Akathisia	13 (6.7)	3 (3.3)	(<5)
Vomiting	12 (6.2)	3 (3.3)	(<5)
Overdose	12 (6.2)	4 (4.4)	(<5)

OLE, open-label extension; RCT, randomized controlled trial.