SAFETY OF GADOTERIDOL INJECTION - US CLINICAL-TRIAL EXPERIENCE

As part of the clinical evaluation of gadoteridol injection, intraveno us doses ranging from 0.05 to 0.3 mmol/kg were administered to 1,709 p atients and volunteers. Safety monitoring included pre- and postdose p hysical examinations, vital signs, and clinical laboratory values, Adv erse event recording included occurrence, duration, severity, relation ship to injection, and clinical importance. No clinically important ch anges in physical examination results, electrocardiograms, or vital si gns were attributed to gadoteridol injection except for one case of hy potension, Four clinically important changes in laboratory values poss ibly or definitely related to the contrast agent were noted in two pat ients (0.1%), Adverse events were recorded in 118 subjects (6.9%), inc luding nausea in 24 subjects (1.4%) and taste perversion in 22 subject s (1.3%), All other adverse events occurred with a frequency of less t han 1%, Adverse events related to contrast agent administration occurr ed in 79 subjects (4.6%), Gadoteridol injection demonstrated excellent clinical safety and patient tolerance at various doses and injection rates.