POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN THE NETHERLANDS

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14470
• EU PAS number:
  EUPAS5184
• Study ID:
  14470
• Official title and acronym:
  POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN THE NETHERLANDS
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This will be a descriptive study using retrospectively collected data from electronic health record databases. The study will describe the utilization pattern of apixaban in the Netherlands (01 Dec 2011 through 31 Dec 2014).
• Study status:
  Finalised

Research institutions and networks

Institutions

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Study timelines

Date when funding contract was signed

Planned: 21/05/2012

Actual: 21/05/2012

Study start date

Planned: 01/10/2014

Actual: 01/12/2011

Date of final study report

Planned: 31/05/2016

Actual: 20/05/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb, Pfizer

Study protocol

Initial protocol

cv185102st-prot (pfizer-protocol-b0661018)

Updated protocol

cv185102st-prot-may2015-(pfizer-protocol-b0661018)-red

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable