Evaluation of the effectiveness of Eliquis® (apixaban) risk minimization tools in European

Study identification

• EU PAS number:
  EUPAS10443
• Study ID:
  19658
• Official title and acronym:
  Evaluation of the effectiveness of Eliquis® (apixaban) risk minimization tools in European
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  France

  Germany

  Italy

  Norway

  Spain

  Sweden

  United Kingdom
• Study description:
  Assessment of the risk minimization tools for Eliquis®
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug safety, Risk management & regulatory Practice, Pope Woodhead & Associates (PWA)

United Kingdom

Networks

PopeWoodhead Associates

Study timelines

Date when funding contract was signed

Actual: 28/04/2014

Study start date

Planned: 26/08/2015

Actual: 26/08/2015

Data analysis start date

Actual: 26/08/2016

Date of interim report, if expected

Planned: 28/11/2016

Date of final study report

Planned: 26/05/2017

Actual: 24/05/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb, Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)