Time-to-Onset Analysis

Time-to-onset (TTO) of a given event was calculated as the difference between the start of treatment and the date the event occurred. Analyses of TTO data were performed based on median duration, quartiles, and the Weibull shape parameter (WSP) test (Mazhar et al., 2021), which is used to determine the varying rate of incidence of AEs (Mazhar et al., 2021). The scale parameter α and shape parameter β are used to describe the Weibull distribution (Kinoshita et al., 2020; Mazhar et al., 2021). We calculated the median TTO and WSP of signals with moderate or strong clinical priority after the beginning of the esketamine therapy in order to predict the hazard of the occurrence of these AEs over time. The selection of parameters and criteria for evaluation were described in previous studies (Kinoshita et al., 2020; Mazhar et al., 2021). All WSP tests were conducted using Minitab statistical software (v19.1.0; Minitab LLC, State College, PA, United States).