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 seriousness should be reported in both datasets. Safety analyses are often conducted using only the adverse event dataset, which should feature all safety events reported. We investigated whether the reporting of safety in both datasets was systematically followed and explored the impact of this on safety analyses in ICON8, an ovarian cancer clinical trial.

Methods

Text searches of serious adverse event data identified events that could potentially match the data reported in the adverse eve

SUBMITTER: James EC 

PROVIDER: S-EPMC7495966 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature