An observational study assessing the management of gastrointestinal and urogenital bleeding events in patients with atrial fibrillation treated with dabigatran etexilate (GI/GU bleeding management in AF patients using dab)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19556
• EU PAS number:
  EUPAS5214
• Study ID:
  19556
• Official title and acronym:
  An observational study assessing the management of gastrointestinal and urogenital bleeding events in patients with atrial fibrillation treated with dabigatran etexilate (GI/GU bleeding management in AF patients using dab)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study status:
  Finalised

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Multiple centres: 44 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned: 06/08/2012

Actual: 06/08/2012

Study start date

Planned: 10/01/2013

Actual: 21/01/2014

Data analysis start date

Planned: 23/06/2014

Actual: 30/09/2015

Date of final study report

Planned: 05/08/2014

Actual: 14/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable