Status: Finalised First registered on: 18/11/2013
Last updated on: 28/07/2016
1. Study identification
EU PAS Register NumberEUPAS5177
Official titlePOST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN SWEDEN
Study title acronym
Study typeObservational study
Brief description of the studyThis will be a descriptive study using retrospectively collected data from electronic health record databases. The study will describe the utilization pattern of apixaban in Sweden (01 Jan 2012 through 31 Dec 2014).
Was this study requested by a regulator?Yes: Germany, United Kingdom
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 belongsClinical Pharmacology at Karolinska
Department/Research groupDivision of Clinical Pharmacology
Organisation/affiliationKarolinska Institutet
Website/Homepage
Details of (Primary) lead investigator
Title Dr
Last name Schachterle
First name Stephen
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

Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/09/201116/09/2011
Start date of data collection01/10/201405/11/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report31/05/201620/05/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBristol-Myers Squibb, Pfizer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schachterle
First name Stephen
Address line 1219 East 42nd Street
Address line 2 
Address line 3 
CityNew York 
Postcode10017 
CountryUnited States
Phone number (incl. country code)1-212-7339192 
Alternative phone number1-646-2705462 
Fax number (incl. country code) 
Email address stephen.schachterle@pfizer.com
Public Enquiries
Title Dr 
Last name Schachterle 
First name Stephen 
Address line 1219 East 42nd Street 
Address line 2 
Address line 3 
CityNew York 
Postcode10017 
CountryUnited States 
Phone number (incl. country code)1-212-7339192 
Alternative phone number1-646-2705462 
Fax number (incl. country code) 
Email address stephen.schachterle@pfizer.com 
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