Status: Finalised First registered on: 09/02/2019
Last updated on: 13/06/2019
1. Study identification
EU PAS Register NumberEUPAS27963
Official titleSevere hypersensitivity reactions associated with iv iron containing medicinal products in countries of the European Economic Area – before and after implementation of risk minimisation measures
Study title acronym
Study typeOther: This is a pharmacoepidemiologic study with case-population design.
Brief description of the studyEvaluation of the reported rate of severe hypersensitivity reactions after administration of iv irons with respect to overall exposure in countries of the European Economic Area by using information from existing data sources
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsIQVIA
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Annegret
First name Gohlke
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Austria
Belgium
Bulgaria
Croatia
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Lithuania
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/11/2018
Start date of data collection26/11/201826/11/2018
Start date of data analysis07/12/201817/12/2018
Date of interim report, if expected
Date of final study report15/02/201919/02/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesVifor International AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name Ehlken
First name Birgit
Address line 1Landshuter Allee 10
Address line 2 
Address line 3 
CityMuenchen 
Postcode80637 
CountryGermany
Phone number (incl. country code)49-89-4579126400 
Alternative phone number 
Fax number (incl. country code) 
Email address birgit.ehlken@iqvia.com
Public Enquiries
Title Mrs 
Last name Ehlken 
First name Birgit 
Address line 1Landshuter Allee 10 
Address line 2 
Address line 3 
CityMuenchen 
Postcode80637 
CountryGermany 
Phone number (incl. country code)49-89-4579126400 
Alternative phone number 
Fax number (incl. country code) 
Email address birgit.ehlken@iqvia.com 
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