Adverse event load, onset, and maximum grade: A novel method of reporting adverse events in cancer clinical trials.
Guilherme S LopesChristophe TournigandCurtis L OlswoldRomain CohenEmmanuelle KempfLeonard SaltzRichard M GoldbergHerbert HurwitzCharles FuchsAimery de GramontQian ShiPublished in: Clinical trials (London, England) (2020)
We developed an adverse event reporting method that provides clinically relevant information about treatment toxicity by incorporating two longitudinal adverse event metrics to the traditional maximum grade approach. Future research should establish clinical benchmarks for metrics included in this adverse event reporting method.