Efficacy
SE
REMISSION, POSITIVE
Overall, 7/178 (3.93%) participants relapsed during the study between days 20 and 703 of study enrolment. Time to relapse is depicted in a Kaplan Meier plot (Kaplan Meier estimates of time to relapse during the open-label extension. PP6M, paliperidone palmitate 6-month formulation.During this 2-year follow-up, participants maintained the clinical and functional improvement achieved during the DB study, as reported by PANSS, CGI-S, and PSP scores (Summary of Efficacy Endpoints: Change From Baseline to Endpoint of Open-label Extension (Intent-to-Treat Set)Abbreviations: CGI-S, Clinical Global Impression-Severity; DB, double-blind; PANSS, Positive and Negative Symptom Scale; PSP, Personal and Social Performance; SD, standard deviation.Mean (±SE) (A) CGI-S, (B) PSP total, (C) PANSS total scores, over time from double-blind study to end of open-label extension. CGI-S, Clinical Global Impression-Severity; DB, double-blind; OL, open-label; PANSS, Positive and Negative Symptom Scale; PSP, Personal and Social Performance; PP3M, paliperidone palmitate 3-month product; PP6M, paliperidone palmitate 6-month product; SE, standard error. Note: Lower scores in PANSS and CGI indicate improvement and higher scores in PSP denote an improvement.Symptomatic remission, as measured by PANSS subscale scores, occurred in 81.5% of all participants at 12 months and 84.4% at 24 months, with the PP6M/PP6M group showing slightly higher remission rates at all timepoints (PANSS Symptomatic Remission During Open-Label ExtensionAbbreviations: PANSS, Positive and Negative Symptom Scale; PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation.
