Post-authorisation Safety Study: Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide

First published 28/02/2013

Last updated 02/07/2024

EU PAS number:

EUPAS3590

Study

Finalised

Documents

Study protocol

Initial protocol

0303209 Final Protocol_V1.1_signed

English (717.61 KB - PDF)View document

Updated protocol

0303209 Final Protocol_V1.1_blackout

First published: 22/02/2024

English (744.28 KB - PDF)View document

Study results

Study report

Other information

Publications

Study publications

ENCePP Seal

ENCePP Seal documents

Signed checklist for study protocols

ENCePP Check list for Study Protocols (Revision2)_5Mar2013

English (1.58 MB - PDF)View document

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