Long-acting injectable paliperidone palmitate versus oral paliperidone extended release: a comparative analysis from two placebo-controlled relapse prevention studies

Table 1 Efficacy and safety outcomes

Outcome	Measures and definitions ^a
Efficacy
CGI-S	Change in CGI-S score
PANSS	Change in total PANSS scores
Relapse	Time to first relapse and percentage relapse
PSP	Change in PSP total score
PSP	Frequency of PSP category change (categories 0 to 70, 71 to 100)
Safety
AEs	Overall incidence, n (%)
	Serious AEs, n (%)
	AEs leading to discontinuation, n (%)
	AEs of interest (EPS-related and prolactin-related AEs), n (%)
Weight gain	≥7% weight increase

^aFrom double-blind baseline to double-blind end point. AE adverse event, CGI-S Clinical Global Impressions–Severity, EPS extrapyramidal symptoms, PANSS Positive and Negative Syndrome Scale, PSP Personal and Social Performance.

ISSN: 1744-859X