Call for standardised reporting of adverse events
Reviewed by Arun K Sharma

This article will be of immense benefit to all of us involved in mortality and morbidity meetings and Clinical Governance, especially registrars and junior members of the team. The authors present data from the UK, USA and Europe. In prostate cancer treatment there is no standard for reporting adverse events. Differences in reporting can influence adverse events of next generation androgen deprivation therapy agents (ngADT) in prostate cancer. A systematic review and meta-analysis of randomised controlled trials (RCT) of ngADT in prostate cancer and databases of adverse events were studied. Fatigue is most commonly reported for enzalutamide (20% controls, 30% enzalutamide). Risk of hypokalaemia is more common with abiraterone therapy. ngADT are also associated with cardiovascular side-effects. Some trials report cardiovascular adverse events per se, whilst others divide these into further subheadings – i.e. 1) cerebrovascular, 2) cardiac. Proper adverse event analysis is not possible at present. However, the guidelines working group should cover adverse events reporting in the recommendations section. My view is that uniformity in reporting is essential as it has a direct impact on a patient’s compliance of any new drug therapy and spiralling cost of novel agents.

A call for standardized reporting of adverse events.
Fankhauser C, Wettstein MS, Pedregal M, et al.
EUROPEAN UROLOGY
2020;78(3):481-2.