Status: Finalised First registered on: 30/11/2017
Last updated on: 08/09/2021
1. Study identification
EU PAS Register NumberEUPAS20720
Official titleIntravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions
Study title acronym
Study typeObservational study
Brief description of the studyIn September 2013, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (EMA-PRAC) recommended that marketing authorisation holders of intravenous iron compounds conduct a postauthorisation safety study (PASS) to further characterise the safety concerns regarding hypersensitivity reactions. This is a multinational, longitudinal cohort study of new users of intravenous iron compounds conducted in populations covered through electronic health databases and patient registries in Denmark, the Netherlands, France, Germany, and Sweden. The study aims to evaluate the risk of anaphylactic or severe immediate hypersensitivity reactions on the day of or the day after the first intravenous iron use by estimating the incidence proportions of anaphylactic reactions in patients who were first dispensed/administered intravenous iron (new users). Incidence estimates will be calculated for patients overall, by group of intravenous iron product, and by type of intravenous iron product. Risk ratios will be used to compare the risk of anaphylaxis between intravenous iron groups and among the various intravenous iron types at the first exposure. The risk of anaphylactic reactions among new users of an intravenous anaphylaxis marker (penicillin), a compound for which anaphylaxis is a well-recognised side effect, will be estimated to provide context for the risk in users of intravenous iron.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Mrs
Last name Gutierrez
First name Lia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?9

Centre for Pharmacoepidemiology (CPE)
PHARMO Institute
BIPS GmbH
Aarhus University Dept. of Clinical Epidemiology
RTI-HS
Bordeaux PharmacoEpi
DIMDI
Carl von Ossietzky University of Oldenburg, Oldenburg, Germany
University Hospital of Cologne - Board of Trustees for Dialysis and Kidney Transplantation (KfH-QiN), Cologne, Germany
Countries in which this study is being conducted
International study

Denmark
France
Germany
Netherlands
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/02/201716/03/2017
Start date of data collection30/03/201809/03/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report30/03/202029/04/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesIV Iron Marketing Authorisation Holders (MAH) Consortium, comprising 17 MAHs (see Annex 3 in protocol for full list)100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name Gutierrez
First name Lia
Address line 1Av. Diagonal, 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34-932417764 
Alternative phone number34-932417766 
Fax number (incl. country code)34-937608507 
Email address lgutierrez@rti.org
Public Enquiries
Title Mrs 
Last name Gutierrez 
First name Lia 
Address line 1Av. Diagonal, 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34-932417764 
Alternative phone number34-932417766 
Fax number (incl. country code)34-937608507 
Email address lgutierrez@rti.org 
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