Analysis and reporting of adverse events in randomised controlled trials: a review.

ABSTRACT:

Objective

To ascertain contemporary approaches to the collection, reporting and analysis of adverse events (AEs) in randomised controlled trials (RCTs) with a primary efficacy outcome.

Design

A review of clinical trials of drug interventions from four high impact medical journals.

Data sources

Electronic contents table of the BMJ, the Journal of the American Medical Association (JAMA), the Lancet and the New England Journal of Medicine (NEJM) were searched for reports of original RCTs published between September 2015 and September 2016.

Methods

A prepiloted checklist was used and single data extraction was performed by three reviewers with independent check of a randomly sampled subset to verify quality. We extracted data on collecti

SUBMITTER: Phillips R 

PROVIDER: S-EPMC6398660 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature