ETX2514 and ETX2514SUL Sample Clauses

ETX2514 and ETX2514SUL. With respect to PK: • ETX2514 demonstrated linear PK and had no evidence of accumulation. • ETX2514 did not interact with sulbactam and/or imipenem/cilastatin. • ETX2514 was predominantly excreted renally and dose adjustments are necessary for patients with moderate or severe renal insufficiency including dialysis. Similarly, higher doses are recommended for patients with augmented renal clearance or receiving continuous renal replacement therapy. • ETX2514SUL demonstrated good penetration of the lung epithelium. With respect to efficacy: • ETX2514SUL when dosed with imipenem/cilastatin showed comparable efficacy to placebo + imipenem/cilastatin in treatment of hospitalized patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP). Among patients with imipenem nonsusceptible infections, imipenem when combined with ETX2514SUL was able to successfully treat 3 out of 3 infections. With respect to safety and tolerability: • ETX2514 was generally safe and well tolerated when given alone or with sulbactam and/or imipenem/cilastatin. • To date, there have been no serious adverse drug reactions or deaths in clinical studies. • The most common adverse events seen have been headache and infusion site reactions, including phlebitis and vascular pain at the infusion site. • Mild reductions in total white blood cell (WBC) and absolute neutrophil counts have been observed with multiple doses of ETX2514SUL, although no events of leukopenia or neutropenia have been observed. • Asymptomatic, transient increases in hepatic enzymes, unaccompanied by increases in bilirubin, have been observed with ETX2514SUL, and these are thought to be related to known effects of sulbactam. • Allergic reactions including urticaria have been observed at rates <1%, with ETX2514SUL, and all have been mild or moderate. • No clinically significant changes in xxxxx xxxxx or ECG parameters have been observed with ETX2514SUL in patients. Transient increases in systolic blood pressure within normal ranges were observed in healthy elderly subjects dosed with ETX2514SUL.