Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studi...

Full description

Bibliographic Details
Main Authors: Jeppe Bennekou Schroll, Elisabeth I Penninga, Peter C Gøtzsche
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2016-08-01
Series:PLoS Medicine
Online Access:http://europepmc.org/articles/PMC4987052?pdf=render