A pharmacoepidemiological study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice in the Netherlands

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43223
• EU PAS number:
  EUPAS11141
• Study ID:
  43223
• Official title and acronym:
  A pharmacoepidemiological study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice in the Netherlands
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This prospective cohort study will provide information about: Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first time The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.
• Study status:
  Finalised

Research institution and networks

Institutions

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Study timelines

Date when funding contract was signed

Actual: 30/01/2012

Study start date

Actual: 01/02/2012

Date of final study report

Actual: 26/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer HealthCare AG

Study protocol

Initial protocol

16646_PHARMO_Rivaroxaban protocol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)