The proportions of patients who had adverse events, serious adverse events, and adverse events leading to the discontinuation of a study drug were similar in the empagliflozin group and the placebo group . Genital infection was reported in a higher percentage of patients in the pooled empagliflozin group. Urosepsis was reported in 0.4% of patients in the empagliflozin group and 0.1% of those in the placebo group.