(A) Effect of empagliflozin on outcomes in the total population and by occurrence of HYPO-broad in EMPA-REG OUTCOME. (B) Effect of empagliflozin on outcomes in the total population and by occurrence of HYPO-strict in EMPA-REG OUTCOME. Based on a Cox regression model with terms for age, sex, baseline body mass index categories, baseline glycated haemoglobin categories, baseline estimated glomerular filtration rate categories, geographical region, treatment, time-varying covariate of HYPO-broad or HYPO-strict, interaction of treatment, and time-varying covariate of HYPO-broad or HYPO-strict. Patients were treated with ≥1 dose of study drug; only for presentation of patient numbers, those with/without HYPO-broad or HYPO-strict were determined at the time of cardiovascular event/censoring. *P value for interaction. 3P-MACE, three-point major adverse cardiovascular event (CV death, non-fatal MI, or non-fatal stroke); AE, adverse event; BMI, body mass index; CV, cardiovascular; eGFR, estimated glomerular filtration rate; HbA1c, glycated haemoglobin; HHF, hospitalization for heart failure; HYPO-broad, time to first symptomatic hypoglycaemic AE with PG ≤70 mg/dL, any hypoglycaemic AE with PG <54 mg/dL, or a severe hypoglycaemic AE (requiring assistance regardless of PG level); MI, myocardial infarction; PG, plasma glucose.