A real-world pharmacovigilance study of FDA adverse event reporting system events for Capmatinib

Area of Science:

• Oncology
• Pharmacovigilance
• Drug Safety

Background:

• Capmatinib is an approved targeted therapy for metastatic non-small cell lung cancer.
• Real-world data on capmatinib's safety profile is limited.
• Understanding drug-induced adverse events is crucial for patient safety.

Purpose of the Study:

• To evaluate capmatinib-induced adverse events using real-world data.
• To identify novel safety signals associated with capmatinib treatment.
• To investigate demographic and clinical factors influencing adverse event risk.

Main Methods:

• Data mining of the FDA Adverse Event Reporting System (FAERS) database.
• Application of four disproportionality analysis methods to detect adverse event signals.
• Stratified analysis based on sex, age, weight, dose, onset time, continent, and concomitant medications.

Main Results:

• 1518 reports and 4278 adverse events linked to capmatinib were identified.
• New significant signals included dysphagia, dehydration, deafness, vocal cord paralysis, muscle disorder, and oesophageal stenosis.
• Specific risks were noted for females (liver enzyme increases, especially with immune checkpoint inhibitors), Americans over 65 (peripheral swelling), and Asians (renal impairment with doses >400mg).

Conclusions:

• This study expands the known safety profile of capmatinib.
• Identified adverse events and risk factors can inform clinical practice and patient monitoring.
• Further real-world data analysis is essential for comprehensive drug safety assessment.