ECG Changes Between-group comparisons for pooled placebo-controlled trials revealed no statistically significant differences between risperidone and placebo in mean changes from baseline in ECG parameters, including QT, QTc, and PR intervals, and heart rate. When all RISPERDAL ® doses were pooled from randomized controlled trials in several indications, there was a mean increase in heart rate of 1 beat per minute compared to no change for placebo patients. In short-term schizophrenia trials, higher doses of risperidone ( 8-16 mg/ day) were associated with a higher mean increase in heart rate compared to placebo ( 4-6 beats per minute) . Other Events Observed During the Premarketing Evaluation of RISPERDAL ® During its premarketing assessment, multiple doses of RISPERDAL ® were administered to 2607 patients in Phase 2 and 3 studies. The conditions and duration of exposure to RISPERDAL ® varied greatly, and included ( in overlapping categories) open-label and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and short-term or longer-term exposure. In most studies, untoward events associated with this exposure were obtained by spontaneous report and recorded by clinical nvestigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of ndividuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories. In two large studies, adverse events were also elicited utilizing the UKU ( direct questioning) side effect rating scale, and these events were not further categorized using standard terminology. ( Note: These events are marked with an asterisk in the listings that follow. ) | ||||
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