Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 19

EMA uses this phrase for an SAR in a clinical trial that is serious, not listed (i.e., unexpected) in the reference safety information, e.g., investigator brochure, and suspected to be due to the drug in question. See the definitions for serious and unexpected. The FDA does not use this definition or initialism formally for cases, though the concept is similar to SUSAR; FDA wording for this concept is “Suspected, Unexpected, Serious Adverse Reaction”. Such an SAR will ordinarily trigger an expedited report in the EU and consideration of expedited reporting to FDA (see below). The acronym “SUSAR” is only applied to clinical trial data, i.e., it does not apply to spontaneous reports in the post-marketing phase.