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Adverse events reporting of XPO1 inhibitor - selinexor: a real-word analysis from FAERS database
Yi Liu1, Runyu Yang1, Hui Feng1
1Department of Hematology, The First Affiliated Hospital of Xi'an Jiaotong University, No. 277 Yanta West Road, Xi'an, 710061, Shaanxi, China.
Abstract:
As the world's first oral nuclear export inhibitor, selinexor is increasingly being used in clinical applications for malignant tumors. However, there is no extensive exploration on selinexor's adverse events (ADEs), necessitating a real-word assessment of its clinical medication safety. FAERS data (July 2019-June 2023) were searched for selinexor ADE reports across all indications. Use the system organ class (SOC) and preferred terms (PT) from the medical dictionary for regulatory activities (MedDRA) to describe, categorize, and statistic ADEs. Disproportionality analysis was employed through calculation of reporting odds ratio (ROR) and proportional reporting ratio (PRR). Based on total of 4392 selinexor related ADE reports as the primary suspect (PS), of which 2595 instances were severe outcomes. The predominant ADEs included gastrointestinal disorders, myelosuppression symptoms, and various nonspecific manifestations. 124 signals associated with selinexor ADE were detected, and 10 of these top 15 signals were not included into the instructions. Our study provides real-world evidence regarding the drug safety of selinexor, which is crucial for clinicians to safeguard patients' health.
Insights
Selinexor, an oral cancer drug, has significant adverse events (ADEs) including gastrointestinal and blood disorders. This real-world study identified 124 safety signals, with 10 not listed in current drug instructions.
Area of Science:
- Pharmacovigilance
- Oncology
- Clinical Pharmacology
Background:
- Selinexor is the first oral nuclear export inhibitor for malignant tumors.
- Limited real-world data exists on selinexor's adverse drug events (ADEs).
Purpose of the Study:
- To conduct a real-world safety assessment of selinexor's ADEs.
- To identify and categorize selinexor-associated ADEs using FAERS data.
Main Methods:
- Utilized FDA Adverse Event Reporting System (FAERS) data from July 2019 to June 2023.
- Employed Medical Dictionary for Regulatory Activities (MedDRA) for ADE classification (SOC, PT).
- Applied disproportionality analysis (ROR, PRR) to detect safety signals.
Main Results:
- Analyzed 4,392 selinexor-related ADE reports, with 2,595 severe outcomes.
- Predominant ADEs involved gastrointestinal disorders, myelosuppression, and nonspecific symptoms.
- Detected 124 selinexor ADE signals; 10 of the top 15 were not in product labeling.
Conclusions:
- Provides crucial real-world evidence on selinexor's drug safety profile.
- Highlights the need for updated clinical guidance on selinexor-associated risks.
- Supports enhanced patient monitoring and risk management strategies for selinexor therapy.
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