Safety Evaluation
hepatic injury, HFpEF, fractures, hypoglycemic, sepsis, acute kidney injury
DIABETIC KETOACIDOSIS, KETOACIDOSIS, URINARY TRACT INFECTIONS, ACUTE PYELONEPHRITIS, ADVERSE EVENTS, HEART, GENITAL INFECTIONS, EVENTS, SEPSIS
Safety parameters included adverse events, predefined adverse events of special interest (eg, hepatic injury, decreased renal function, and diabetic ketoacidosis), and specific adverse events defined for this study (eg, hypoglycemic events, genital infections, acute pyelonephritis, sepsis, urinary tract infections, bone fractures, hepatic injury, ketoacidosis, and acute kidney injury), clinical safety laboratory assessments, vital signs, 12-lead ECG, and New York Heart Association class. Details on collection of adverse events and overall safety of empagliflozin in patients with HFrEF and HFpEF can be found in 