Abstract #2235

Prospective Observational Post-marketing Study on the Safety of Gadoterate Meglumine - Final Results in the pediatric cohort of over 1,600 children

Yun Peng¹

¹Beijing Children's Hospital, Beijing, China, People's Republic of

An observational post-marketing study was conducted in 10 countries to prospectively collect safety data in adults and children who were scheduled to undergo routine Magnetic Resonance Imaging (MRI) with administration of gadoterate meglumine (Dotarem®). The incidence of Nephrogenic Systemic Fibrosis (NSF) in routine practice was assessed through specific follow-up of patients with moderate to severe renal impairment. Final results in a large pediatric sub-population of over 1,600 children showed a very good safety profile of gadoterate meglumine with only one adverse event reported in a child and no suspicion of NSF reported.

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