A consistent system for reporting adverse events (AEs) is paramount in @entity5 clinical trials and is crucial to ensure the safety and tolerability of chemotherapy. The shift towards individualized medicine in oncology over the last decade has brought with it an impressive array of novel, targeted therapies and increasingly complex clinical trials to investigate them. Many of the newer drugs are oral agents that are taken continuously over protracted periods of time. They stand sharply in contrast to conventional cytotoxic intravenous chemotherapy given over a prefixed number of cycles. With its narrow emphasis on high-grade events, the consensus method for reporting of AEs in current @entity5 trials has not evolved to reflect the @entity137 profiles of the newer agents. Current methods do not incorporate @entity1 -reported outcomes, which are of rising importance when therapy lasts for months or even years in a @entity1 's life. Additionally, tables focusing on worst-grade events do not depict evolution of @entity137 over time and therefore cannot offer @entity1 and clinicians information about the onset or duration of a given AE. Most importantly, current methods do not capture lower-grade but longer-lasting @entity137 that may have important ramifications on @entity1 ' quality of life. The failure to include any time-related information in our current methods of @entity137 reporting provides an incomplete and even inaccurate depiction of AEs. To remain in step with the advancing science of @entity5 and the vast array of new therapies with extended treatment durations, our consensus method of AE analysis in oncology clinical trials must modernize to include the dimension of time.

The Imperative for a New Approach to XXXX Analysis in Oncology Clinical Trials.

@entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'longitudinal toxicity']
@entity137 :: (MESH:D064420,Disease) :: ['Toxicity']
