Postmarketing safety of anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS).

ABSTRACT:

Background

Inhibitors of the anaplastic lymphoma kinase (ALK) gene mutation are highly effective treatments for ALK-positive lung cancer. We conducted this pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS).

Patients and methods

FAERS files from 2012 to 2020 were used. Reports for crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib were filtered. We used the Medical Dictionary for Regulatory Activities (MedDRA version 22.1). Further, we searched for adverse events on the preferred term (PT) level based on case reports in the literature. After filtering duplicate reports, disproportionality analysis was used to detect safety signals by calculating proportional reporting ratios (PRRs), reporting odds ratios (RORs),

SUBMITTER: Omar NE 

PROVIDER: S-EPMC8649649 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature