Status: Finalised First registered on: 01/10/2015
Last updated on: 23/09/2021
1. Study identification
EU PAS Register NumberEUPAS11141
Official titleA pharmacoepidemiological study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice in the Netherlands
Study title acronym
Study typeObservational study
Brief description of the studyThis prospective cohort study will provide information about: Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first time The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.
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 belongsPHARMO Institute
Department/Research groupUtrecht, Netherlands
Organisation/affiliationThe PHARMO Institute for Drug Outcomes Research
Website/Homepagewww.pharmo.nl
Details of (Primary) lead investigator
Title Dr
Last name Herings
First name Ron
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
National study

Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/01/2012
Start date of data collection01/02/2012
Start date of data analysis
Date of interim report, if expected
Date of final study report26/11/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer HealthCare AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Herings
First name Ron
Address line 1Van Deventerlaan 30-40
Address line 2 
Address line 3 
CityUtrecht 
Postcode3528 AE 
CountryNetherlands
Phone number (incl. country code)31307440800 
Alternative phone number31307440803 
Fax number (incl. country code) 
Email address pharmo@pharmo.nl
Public Enquiries
Title Dr 
Last name Bayer HealthCare AG 
First name CTP Team / Ref: "ENCePP"/ Bayer Pharma AG 
Address line 1Müllerstraße 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayerhealthcare.com 
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