Status: Finalised First registered on: 05/12/2013
Last updated on: 16/12/2016
1. Study identification
EU PAS Register NumberEUPAS5365
Official titleDrug Utilization Study of ZALTRAP® (aflibercept) Using European Databases
Study title acronymZaltrap Utilization Study
Study typeObservational study
Brief description of the studyDuring the registration application with EMA for aflibercept to be marketed in the EU, Sanofi proposed a three-year drug utlization study (DUS) using European databases as part of the post-approval commitments. The primary objectives of the proposed DUS are to monitor ZALTRAP use in cancer patients including potential off-label use and evaluate the potential for intravitreal use.
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 belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Schabert
First name Vernon
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

France
Germany
Italy
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/08/201316/10/2013
Start date of data collection01/01/201301/01/2013
Start date of data analysis02/06/201402/06/2014
Date of interim report, if expected30/11/201430/11/2014
Date of final study report30/11/201630/11/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSanofi100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schabert
First name Vernon
Address line 11725 Duke Street, Suite 510
Address line 2 
Address line 3 
CityAlexandria, Virginia 
Postcode22314 
CountryUnited States
Phone number (incl. country code)1-703-8375174 
Alternative phone number 
Fax number (incl. country code) 
Email address VSchabert@us.imshealth.com
Public Enquiries
Title Dr 
Last name Schabert 
First name Vernon 
Address line 11725 Duke Street, Suite 510 
Address line 2 
Address line 3 
CityAlexandria, Virginia 
Postcode22314 
CountryUnited States 
Phone number (incl. country code)1-703-8375174 
Alternative phone number 
Fax number (incl. country code) 
Email address VSchabert@us.imshealth.com 
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