- •Only 5 of 10 Consolidated Standards of Reporting Trials harms recommendations were fulfilled on average.
- •Adverse event (AE) assessments, number of AEs, and denominators were well reported.
- •The specific AEs evaluated and withdrawals due to AEs were less well reported.
- •Little improvement in AE reporting occurred between 2000 to 2003 and 2008 to 2012.
- •8% of the reviewed articles failed to report any information on AEs.
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Financial support for this project was provided by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA). ACTTION has received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, and other sources. The views expressed in this article are those of the authors, none of whom have financial conflicts of interest specifically related to the issues discussed in this article. No official endorsement by the FDA or the pharmaceutical and device companies that have provided unrestricted grants to support the activities of ACTTION should be inferred.