Lantheus Medical Imaging said that a multicenter study has demonstrated the safety and tolerability of its Definity ultrasound contrast agent in a large and diverse patient population.
No deaths, life-threatening events, serious adverse events, or serious anaphylactoid reactions were reported during or after Definity administration in the Contrast Echocardiography Registry for Safety Surveillance (CARES) trial. Results were published in the July issue of the Journal of the American Society of Echocardiography.
The trial included more than 1,000 patients in a routine clinical setting with wide-ranging characteristics, including pre-existing cardiopulmonary conditions and critical illness, Lantheus said.
The overall adverse event rate was 10.8%, and the drug-related adverse event rate was 3.5%, Lantheus said. Of the adverse events that occurred during or after Definity administration, 96.5% were mild to moderate in intensity, according to the company.
