Study Design and Data Collection
This is a retrospective, pharmacovigilance study of adverse event
analysis of the U.S. Food and Drug Administration’s Adverse Event
Reporting System (FEARS) database. FAERS is an online publicly available
post-marketing pharmacovigilance database that records millions of
adverse events, medication error reports, and product quality complaints
submitted by healthcare professionals, manufacturers, and consumers
worldwide for approved drugs and biologic products. Reports are
evaluated by clinical reviewers in the Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research. The
database includes data regarding the suspected pharmaceutical agent,
indication for its use, patient characteristics, as well as the reported
adverse event including its date of occurrence, nature, and outcome,
among others. Since the data is anonymized, approval by an ethics
committee (i.e. IRB approval) was not required for this analysis. We
aimed to evaluate the cardiovascular adverse events associated with
newly FDA-approved multiple-myeloma therapeutic agents from the approval
till May 2021. Queries for the specific adverse event terms were
performed according to the Medical Dictionary for Regulatory Activities.
The terms used include “atrial fibrillation”, “congestive cardiac
failure, cardiac failure congestive”, “ventricular dysfunction”,
“systolic dysfunction”; “diastolic dysfunction”, “cardiac
disfunction”, “cardiac failure”, “cardiomyopathy”, “myocardial
infarction”, “angina pectoris”, “coronary artery disease”,
“coronary artery occlusion”, “angina unstable”, silent myocardial
infarction, “acute coronary syndrome” and were organized in these main
groups.