Published August 23, 2021 | Version 1.0
Project deliverable Open

ACCESS-Background rate of adverse events-definition –Single Organ Cutaneous Vasculitis

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

Description

This document contains the definition of Single Organ Cutaneous Vasculitis 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

Notes

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

Files

ACCESS_DefinitionForm_SOCVv1.020210823.pdf

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