Changing adverse event reporting in hematological malignancies
by Dr. Jan Hein van Dierendonck
Several hematological malignancies are now chronic diseases that are treated with continuously administered therapies that have unique side effects over time. However, traditional approaches to reporting and analyzing adverse events (AEs) are inadequate in this era of modern therapeutics. Dr Gita Thanarajasingam (Mayo Clinic, Rochester, USA) guides an international commission on improving AE assessment in hematological malignancies, which recently produced a ‘call to action paper’ with tangible targets and timelines for improvement.1
“The conventional ‘maximum grade’ approach to reporting and analyzing AEs is insufficient. Novel longitudinal approaches may be able to portray additional complementary information on AE time frame and chronic, low grade events. We have defined priority areas for improving AE assessment and proposed future directions for improvement across the spectrum of hematological malignancies”, said Thanarajasingam in a Hematology-in-Focus session.