Signal mining and analysis of adverse events of sacituzumab govitecan
- VernacularTitle:戈沙妥珠单抗的药物不良事件信号挖掘与分析
- Author:
Yilu WANG
1
;
Ke ZHANG
1
;
Zhengxiang LI
1
Author Information
1. Dept. of Pharmacy，Tianjin Medical University General Hospital，Tianjin 300052，China
- Publication Type:Journal Article
- Keywords:
sacituzumab govitecan;
adverse drug event;
antibody-drug conjugate;
data mining
- From:
China Pharmacy
2024;35(20):2527-2532
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To mine the adverse drug event （ADE） signals of sacituzumab govitecan and provide a reference for its clinical safety application. METHODS The data of sacituzumab govitecan-related ADE reports were collected from the FDA Adverse Event Reporting System （FAERS） database from April 1， 2020 to April 30， 2024. The reporting odds ratio（ROR） method， the United Kingdom Medicines and Healthcare Products Regulatory Agency comprehensive standard method （MHRA） and Bayesian confidence propagation neural network （BCPNN） method were used for data mining. Systematic organ classification （SOC） and preferred term （PT） in the ADE terminology set of version 27.0 of the Medical Dictionary for Regulatory Activities （MedDRA） were used for data classification and statistics. RESULTS A total of 753 ADE reports were obtained for sacituzumab govitecan， including 46 ADE signals， involving 12 SOCs， and 13 new suspicious ADE signals not recorded in the instructions. Top 5 PTs in terms of occurrence frequency were disease progression， death， diarrhea， off label use and inappropriate schedule of product administration. Top 5 PTs in terms of signal strength were febrile bone marrow aplasia， neutropenic colitis， disease progression， pulmonary sepsis， general physical condition abnormal. New ADE not recorded in the drug instructions included neutropenic sepsis， hepatic cytolysis， meningitis， aplasia， etc. CONCLUSIONS When using sacituzumab govitecan in clinical practice， special attention should be paid to ADE with highly reported cases and strong signal intensity， such as febrile neutropenia， febrile bone marrow aplasia， weight fluctuations， colitis. We should also be alert to new suspected ADE such as neutropenic sepsis， hepatic cytolysis， meningitis， and aplasia to ensure patient medication safety.
