Evaluation of the Safety and Effectiveness of Anticoagulants Among Sub-Groups of Venous Thromboembolism Patients (VTE Subgroups)

Study identification

• EU PAS number:
  EUPAS32365
• Study ID:
  50355
• Official title and acronym:
  Evaluation of the Safety and Effectiveness of Anticoagulants Among Sub-Groups of Venous Thromboembolism Patients (VTE Subgroups)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will add real-world evidence regarding demographic and clinical characteristics, risks of major bleeding, clinically relevant non-major bleeding, and recurrent VTE among VTE patients who initiated treatment with apixaban or warfarin, especially among some high-risk subgroups of patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

SIMr STATinMED

Study timelines

Date when funding contract was signed

Planned:23/04/2019

Actual:23/04/2019

Study start date

Planned:30/11/2019

Actual:18/11/2019

Date of final study report

Planned:15/11/2023

Actual:14/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer/BMS

Regulatory

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