Data Mining and Analysis of Trametinib Related Adverse Events of Nervous System Based on FAERS

Abstract

Objective: To provide a reference for clinical administration of trametinib (TRA), we mine the TRA-related adverse event (ADE) of respiratory system based on the FAERS and explore the characteristics of ADE occurrence, the correlation strength between ADE and TRA and the risk factors of TRA-related ADE of nervous system. Methods: We use reporting odds ratio (ROR) methods and healthcare products regulatory agency (MHRA) methods to mine the TRA-related ADE of nervous system based on the adverse reaction report data of 24 quarters from the first quarter of 2017 to the fourth quarter of 2022 extracted from the FAERS. Results: Totally 4 392 TRA-related reports were obtained, 86ADE of nervous system were reported. There were 15 PT with signal, which could be divided into 7 high level group term (HLGT). The top 3 reported PT were seizure, syncope, sleepy. The top 3 PT with the highest signal intensity were central nervous system lesion, hemiparesis and hydrocephalus. There were 15 PT that were not included in the drug instructions. Conclusions: Need to attach importance to TRA related nervous system the risk of ADE, especially the peripheral neuropathy and hydrocephalus, patients with underlying diseases related to the nervous system need to be closely monitored to ensure the safety of medication.