Study identification

PURI

https://redirect.ema.europa.eu/resource/40537

EU PAS number

EUPAS40527

Study ID

40537

Official title and acronym

Incidence rates of adverse events of special interest: Guillain-Barré syndrome and Bell’s palsy

DARWIN EU® study

No

Study countries

France
Germany
United Kingdom

Study description

Background rates of adverse events of special interest (AESIs) are important in order to be able to determine if an event rate in patients with a certain drug exposure is higher than expected in the general, non-exposed population. Such background rates can then serve as comparator data when reports of suspected adverse reactions are reviewed, for example in the case of immune-mediated or neurologic events for COVID-19 vaccines. This study assesses the feasibility of generating background rates of events of interest in the IMS® Disease Analyzer databases, using two AESIs as a case study: Guillain-Barré syndrome (GBS) and Bell’s palsy. The present study has obtained event rates for Guillain-Barré syndrome and Bell’s palsy using similar methods as in the ACCESS protocol (EUPAS study 37274) 1, 2. Results from this study will be compared to results from ACCESS and from the ADVANCE project 3, 4, which published incidence rates of autoimmune diseases in European healthcare databases 4 between 2003 and 2014. This study also serves as a pilot to define a process for rapid generation of background rates should data be promptly required to address potential safety concerns emerging from the COVID-19 vaccination campaigns.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Karin and Robert Hedenmalm and Flynn

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable