Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database

BACKGROUND: The aim of our study was to analyze adverse events (AEs) associated with radium-223 using real life data from Eudra-Vigilance (EV) database. METHODS: EV database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European economic area (EEA). We recorded number of AEs for radium-223 per category and severity from 2013 to May 2019. We recorded AEs per age group (<65 years old; between 65 and 85 years; >85 years old) pooled relative risk (PRR) were used to compare groups. The number of individual cases identified in EV database was 4339. RESULTS: According to the registry study the most frequent AEs in patients treated with radium-223 were hematological, general and gastrointestinal disorders and they were confirmed as the most frequent AEs in the EV database. In the EV database over 90% of the reported AEs were defined as serious and 8% were fatal. Older patients (>85 years) treated with radium-223 were at increased risk of cardiac, infectious, and metabolism disorders when compared to younger patients (<65). However, we have no information on the number of patients under treatment in the EV database. CONCLUSIONS: EV database highlights several AEs which are not reported in registry studies as well as different AEs profiles according to age. Clinicians should consider these data when treating patients with radium-223.