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

Documents

Study protocol

Initial protocol

0303209 Final Protocol_V1.1_signed

Updated protocol

0303209 Final Protocol_V1.1_blackout

First published: 22/02/2024

Study results

Study report

Other information

Publications

Study publications

Arana A, Johannes C, Varas C, Rothman KJ, McQuay L, Yang Q. Assessment of daily…

Arana A, Johannes CB, McQuay LJ, Varas-Lorenzo C, Fife D. Risk of Out-of-Hospit…

Varas-Lorenzo C, Arana A, Johannes CB, McQuay LJ, Rothman KJ, Fife D. Improving…

ENCePP Seal

The use of the ENCePP Seal has been discontinued since February 2025. The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

Signed checklist for study protocols

ENCePP Check list for Study Protocols (Revision2)_5Mar2013