A study presented at the European Association of Urology (EAU) 2019 congress shows that real-life data on adverse events (AEs) associated with radium 223 differ from those reported in the ALSYMPCA study.
Data from the registry study indicates that patients treated with radium 223 had a statistically significant higher risk of neutropenia when compared with placebo (pooled relative risk [PRR] 1.65; 95% CI 0.51-5.37). Real-life data collected through the Eudra-Vigilance system show a higher risk of neutropenia (PRR 1.38; 95% CI 0.86-2.19), thrombocytopenia (PRR 1.69; 95% CI 1.27-2.26), asthenia (PRR 1.91; 95% CI 0.28-0.68), pneumonia (PRR 1.69; 95% CI 0.96-3.01), decreased appetite (PRR 1.52; 95% CI 0.99-2.31), spinal cord compression (PRR 1.89; 95% CI 1.16-3.05), psychiatric disorders (PRR 1.57; 95% CI 0.97-2.51) and respiratory disorders (PRR 1.52; 95% CI 1.07-2.17) compared with the clinical trial.
The real-life data also show reports of AEs that had not been reported in the trial, including cardiac disorders, ear and labyrinth disorders, hepato-biliary events, skin and subcutaneous tissue disorders and vascular disorders.
EAU 2019 is taking place in Barcelona, Spain, and will conclude today, Tuesday 19 March.