Status: Finalised First registered on: 07/03/2013
Last updated on: 30/05/2017
1. Study identification
EU PAS Register NumberEUPAS3626
Official titlePan European Multi-Database Bladder Cancer Risk Characterisation Study
Study title acronym
Study typeObservational study
Brief description of the studyThis observational study is being undertaken to further assess the association between pioglitazone use and bladder cancer risk among patients with type 2 diabetes mellitus in four European countries: Finland, Netherlands, Sweden, and United Kingdom.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
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 group
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Korhonen
First name Pasi
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?4

Centre for Pharmacoepidemiology (CPE)
IQVIA
CPRD
PHARMO Institute
Countries in which this study is being conducted
International study

Finland
Netherlands
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/03/201230/03/2012
Start date of data collection30/07/201329/07/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/201630/09/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTakeda Global Research & Development Centre (Europe) Ltd100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-50-3652990 
Alternative phone number 
Fax number (incl. country code) 
Email address pasi.korhonen@epidresearch.com
Public Enquiries
Title Dr 
Last name Korhonen 
First name Pasi 
Address line 1EPID Research Oy 
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-50-3652990 
Alternative phone number 
Fax number (incl. country code) 
Email address pasi.korhonen@epidresearch.com 
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