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Для начала давайте посмотрим, что пишет EMA на своём сайте: "As a help to prioritise the review of reports of suspected Adverse Drug Reactions (ADRs) in the framework of the day to day pharmacovigilance activities the European Medicines Agency has developed the Designated Medical Event (DME) list. This is used by the European Medicines Agency, as well as EEA Member States, to identify reports of suspected ADRs that deserve special attention, irrespective of statistical criteria used to prioritise safety reviews. Therefore, the DME list serves as a safety net to ensure that signals are not missed.
The list includes MedDRA Preferred Terms that identify serious medical concepts often causally associated with drugs across multiple pharmacological/therapeutic classes. It may not address product specific issues, and conditions with high prevalence in the general population are excluded.
The content of the DME list is not definitive and may change as further experience with its use is gathered.
The DME list is published for transparency purposes only." То есть, по сути, перечень DME - это список предпочтительных терминов (ну, или терминов предпочтительного употребления) MedDRA, соответствующих НЛР самых разных лекарственных средств.
Следовательно, DME можно перевести, например, как "установленные нежелательные (или клинические) явления".
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