Skip to main content

Table 1 Efficacy and safety outcomes

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

Outcome Measures and definitions a
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
Frequency of PSP category change (categories 0 to 70, 71 to 100)
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
  1. 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.