Table 1.
Efficacy and safety outcomes
| Outcome | Measures and definitionsa |
|---|---|
| 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 |
| 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.