A pharmacoepidemiological study of rivaroxaban use and potential adverse outcomes in routine clinical practice in Sweden

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43212
• EU PAS number:
  EUPAS9895
• Study ID:
  43212
• Official title and acronym:
  A pharmacoepidemiological study of rivaroxaban use and potential adverse outcomes in routine clinical practice in Sweden
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• 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

Friberg Research AB, Karolinska Institute

Sweden

Study timelines

Date when funding contract was signed

Planned: 10/02/2015

Actual: 10/02/2015

Study start date

Planned: 01/06/2015

Actual: 15/06/2015

Date of final study report

Actual: 26/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer Pharma AG

Study protocol

Initial protocol

Sweden_Rivaroxaban protocol_EMA PASS template_20150120_clean_final

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)