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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14474
• EU PAS number:
  EUPAS5177
• Study ID:
  14474
• Official title and acronym:
  POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN SWEDEN
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  This will be a descriptive study using retrospectively collected data from electronic health recorddatabases. The study will describe the utilization pattern of apixaban in Sweden (01 Jan 2012 through 31 Dec 2014).
• Study status:
  Finalised

Research institution and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Contact details

Stephen Schachterle

Study contact

[e-mail]

Stephen Schachterle

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 16/09/2011

Actual: 16/09/2011

Data collection

Planned: 01/10/2014

Actual: 05/11/2014

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

cv185103st-prot (pfizer-protocol-b0661017)

Updated protocol

cv185103st-prot-may2015 (pfizer-protocol-b0661017)-red

Regulatory

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