Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial

Abstract Background Safety data is required to be collected in all clinical trials and can be separated into two types of data, adverse events and serious adverse events. Often, these types of safety data are collected as two discrete data sets, where adverse events that also meet the criteria for s...

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Bibliographic Details
Main Authors: Elizabeth C. James, David Dunn, Adrian D. Cook, Andrew R. Clamp, Matthew R. Sydes
Format: Article
Language:English
Published: BMC 2020-09-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-020-04718-z