Thromboembolic events reported in association with idarucizumab and andexanet alfa: disproportionality analysis of the Food and Drugs Administration Adverse Eventr Resporting System (FAERS) database (Idarucizumab/andexanet alfa & thromboembolism)

Study identification

• EU PAS number:
  EUPAS107330
• Study ID:
  108399
• Official title and acronym:
  Thromboembolic events reported in association with idarucizumab and andexanet alfa: disproportionality analysis of the Food and Drugs Administration Adverse Eventr Resporting System (FAERS) database (Idarucizumab/andexanet alfa & thromboembolism)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Idarucizumab and andexanet alfa are drugs for the emergency reversal of pharmacological effect of direct oral anticoagulant (DOAC) drugs. However, given the recent commercialization of these two antidotes (2015 for idarucizumab, 2018 for andexanet) and their rare use in clinical practice, evidence on the safety of idarucizumab regarding thromboembolic risk is still limited. The aim of this study is to analyze the Food and Drugs Administration Spontenouse Reporting System (FAERS) database for generating hypothesis on the possible association between the use of idarucizumab and specific thromboembolic events, which can be subsequently verified through ad hoc observational studies.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

Study timelines

Date when funding contract was signed

Actual:25/08/2023

Study start date

Actual:02/10/2023

Date of final study report

Planned:30/11/2024

Sources of funding

Other

More details on funding

ARS

Regulatory

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