Statistical analysis
EVENTS, EVENT
Baseline characteristics and exposure were summarized descriptively. TEAEs were summarized by MedDRA system organ class and preferred term. Exposure-adjusted event rates (EAERs) per 100 patient-years (PY) were summarized as events based on the treatment received at the time of each AE; multiple events occurring in the same patient were included in the numerator; 95% confidence intervals (CIs) were calculated based on the exact method for the Poisson mean [