Published August 20, 2021 | Version 1.2
Project deliverable Open

ACCESS-Background rate of adverse events-definition –Coagulation disorders

  • 1. University Medical Center Utrecht
  • 2. University Utrecht
  • 3. Spanish Medicines Agency


This document contains the definition of Coagulation disorders, such as VTE, ischemic stroke, hemorrhagic stroke, cerebral venous sinus thromboembolism, DIC and Thrombotic Thrombocytopenia Syndrome) and the operationalization to extract this event from different electronic health care databases in the EU, to calculate background rates of AESI

The document contains the key definition, procedures and treatments, the diagnosis codes based on Codemapper output with changes/additions by data access providers, and when available published validation studies and background rates


This study (ACCESS project) was funded by the European Medicines Agency


ACCESS_Cogaluationdisorders event definitionforv1.120210820.pdf

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