The SMART Safety: An empirical dataset for evidence synthesis of adverse events

Evidence synthesis serves an important role to promote in-formed decision-making in healthcare practice. A key issue of evidence synthesis is the approach to deal with rare ad-verse events and the methods to address bias of harm effects. Empirical data is essential to help methodologists and statis-ticians to solve the issues in evidence synthesis of adverse events. For this reason, we have established SMART Safety dataset, the largest empirical dataset of meta-analyses of ad-verse events. The dataset contains 151 systematic reviews with 629 meta-analyses on safety outcomes, which covers more than 2,300 randomized controlled trials and 362 harm outcomes, with 10,069 rows and 45 columns of trial level information. All information was double-or even quadra-checked and further verified by referring the original source (e.g., the full-text of the included randomized trials) to en -sure high validity of the data. (c) 2023 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ )