Safety
hyperglycemia-related TEAEs, Tremor, diabetes mellitus, EPS-related TEAEs, tenderness, EPS-related TEAE, diabetes
ADVERSE EVENT, EVENT, DIABETES MELLITUS, ADVERSE EVENT, EVENTS, DIABETES
Overall, 111/178 participants (62.4%) experienced ≥1 TEAE (Treatment-Emergent Adverse Events in ≥5% of Participants in Any Group in the Open-Label Extension (Intent-to-Treat Set)Abbreviations: PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation; TEAE, treatment-emergent adverse event.
A total of 8/178 participants (4.5%) experienced serious TEAEs (Summary of Serious Treatment-Emergent Adverse Events in Open-Label ExtensionAbbreviations: PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation; TEAE, treatment-emergent adverse event.A low incidence of EPS-related TEAEs was noted (n = 4 participants, 2.2%; all events were new onset). Tremor was the most commonly reported EPS-related TEAE (n = 3 participants, 1.7%).Evaluation of injection site over time, as assessed by erythema/redness, induration/swelling, and tenderness, showed that all parameters were absent or mild at baseline; erythema/redness was absent at endpoint, and induration/swelling and tenderness were mild or absent at endpoint for most participants and severe in 1 participant each (supplementary Median prolactin levels remained relatively stable in men throughout the study, whereas in women, median prolactin levels steadily increased from baseline to month 12 and then steadily declined again between months 12 and 24 (supplementary Four participants (2.2%) reported diabetes mellitus and hyperglycemia-related TEAEs (of which 1 event is reported as new onset of diabetes); the most common was increased blood glucose (2 participants, 1.1%). There were no clinically meaningful changes in body weight, body mass index, or waist circumference.