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 type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  IDARUCIZUMAB

  ANDEXANET ALFA

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  11000000

Study design details

• Main study objective:
  Generate hypotheses regarding the possible association between the use of idarucizumab and specific thromboembolic events, which can be subsequently verified through ad hoc observational studies.
• Data analysis plan:
  Using all reports of suspected adverse drug reactions in the database, the Reporting Odds Ratios will be calculated, with 95% confidence intervals, for idarucizumab and andexanet alfa, respectively, in association with the three relevant SMQs and subsequently in association with each of the PTs contained within each of the three SMQ. Drug-event pairs with ROR>1 and at least 3 reports will be considered as signals of disproportionate reporting. As a sensitivity analysis, the analysis will be restricted to reports concerning any DOAC (i.e. dabigatran, rivaroxaban, apixaban, edoxaban) among suspected, interacting or concomitant drug and at least one among idarucizumab, andexanet alfa or a prothrombin complex concentrate, i.e. the therapeutic alternative to idarucizumab, andexanet alfa, listed as suspected or interacting drug.