A long-term, phase 2, multicenter, randomized, open-label, comparative safety study of pomaglumetad methionil (LY2140023 monohydrate) versus atypical antipsychotic standard of care in patients with schizophrenia

Table 2 Treatment-emergent adverse events at incidence ≥5% in the LY2140023 group, or significantly different between groups

Event, n (%)	LY2140023	SOC	P value
Event, n (%)	(N = 130)	(N = 131)	P value
Patients with ≥ TEAE	100 (76.9)	94 (71.8)	.396
Insomnia	20 (15.4)	10 (7.6)	.054
Anxiety	19 (14.6)	10 (7.6)	.079
Headache	16 (12.3)	10 (7.6)	.222
Vomiting	15 (11.5)	3 (2.3)	.003*
Schizophrenia	12 (9.2)	11 (8.4)	.831
Agitation	11 (8.5)	2 (1.5)	.011*
Blood CPK increases	10 (7.7)	14 (10.7)	.521
Nausea	10 (7.7)	4 (3.1)	.108
Dyspepsia	8 (6.2)	1 (0.8)	.019*
Nasopharyngitis	7 (5.4)	3 (2.3)	.217
Akathisia	1 (0.8)	9 (6.9)	.019 ^*
Weight increased	0 (0.0)	8 (6.1)	.007*

Abbreviations: CPK Creatinine phosphokinase, n/N Number of patients, SOC Standard of care, TEAE Treatment-emergent adverse events.
Groups: LY2140023, LY2140023 monohydrate, SOC, Standard-of-care.
*P < .05, LY2140023 versus SOC. Events significantly different between treatment groups are highlighted in bold text.

ISSN: 1471-244X