Prospective Multicenter Study of the Safety of Gadoteridol in 6163 Patients

Abstract

BACKGROUND: The safety of gadolinium-based contrast agents is of fundamental importance. <br>PURPOSE: To determine the frequency and severity of immediate-type adverse reactions to approved doses of gadoteridol in patients referred for routine gadoteridol-enhanced MRI in actual clinical practice settings. <br>STUDY TYPE: Prospective, observational. <br>POPULATION: In all, 6163 subjects were enrolled (mean age: 56.7 ± 15.4 years; range: 6-93 years). <br>FIELD STRENGTH/SEQUENCE: 1.5T and 3.0T. <br>ASSESSMENT: Assessment was of immediate adverse reactions by the investigating radiologist using the MedDRA System Organ Class and preferred term. <br>STATISTICAL TESTS: Summary statistics for continuous variables, descriptive statistics for demographic characteristics. <br>RESULTS: Overall, 19 adverse events occurred in 13 (0.21%) patients, of which 15 in 10 (0.16%) patients were considered related to gadoteridol administration. These events were evenly distributed between male and female subjects and all occurred in adults. Twelve of the 15 related events in eight (0.13%) patients were considered mild in intensity (rapidly self-resolving), while the remaining three events in two patients (0.03%) were considered moderate in intensity. None were of severe intensity and no serious adverse events occurred. <br>DATA CONCLUSION: The rate of immediate-type adverse events following exposure to approved doses of gadoteridol is extremely low, and mostly limited to transient and self-resolving symptoms. <br>LEVEL OF EVIDENCE: 2 Technical Efficacy Stage: 5