Article,

An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System

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Drug Safety, 43 (5): 457--465 (May 1, 2020)
DOI: 10.1007/s40264-020-00908-5

Abstract

Adverse reactions with an outcome of death are inherently important for pharmacovigilance organizations to evaluate. Prior efforts to systematically evaluate individual case safety reports (ICSRs) with an outcome of death have been limited to high-level summaries.

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