Table 6.

Treatment-emergent Potentially Prolactin-related Adverse Events during OL and DB phases (ITT [OL] Analysis Set and Safety Analysis Set)

Sex	OL PP1M (N=1429) n (%)	PP3M (N=504) n (%)	PP1M (N=512) n (%)
Both	1429	504	512
Galactorrhoea	17 (1.2)	3 (0.6)	5 (1.0)
Sexual dysfunction	4 (0.3)	0	0
Libido decreased	3 (0.2)	0	0
Anorgasmia	1 (0.1)	0	0
Breast enlargement	1 (0.1)	0	0
Breast pain	1 (0.1)	2 (0.4)	0
Blood prolactin increased	0	1 (0.2)	0
Breast discharge	0	1 (0.2)	1 (0.2)
Orgasm abnormal	0	1 (0.2)	0
Orgasmic sensation decreased	0	1 (0.2)	0
Male	782	258	281
Gynaecomastia	3 (0.4)	2 (0.8)	0
Erectile dysfunction	1 (0.1)	1 (0.4)	1 (0.4)
Female	647	246	231
Amenorrhoea	17 (2.6)	8 (3.3)	4 (1.7)
Menstruation irregular	9 (1.4)	5 (2.0)	3 (1.3)

Abbreviations: DB, double-blind; OL, open-label; PP1M, paliperidone palmitate 1-month formulation; PP3M, paliperidone palmitate 3-month formulation.