Abstract
OBJECTIVE: To detect and quantify adverse drug event (ADE) signals linked to 120 mg denosumab in the real world. METHODS: We queried the US Food and Drug Administration Adverse Event Reporting System (FAERS) for reports on 120 mg denosumab, standardized, and categorized these events with Preferred Terms (PT) and System Organ Classes (SOC) from MedDRA version 27.1. Disproportionality analysis was performed using the reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN). RESULTS: We identified 10,963 ADE reports for 120 mg of denosumab. Among 10 963 reports, 41.6% of patients were ≥ 65 years old, 37.1% were from the United States, and 17.7% were from Japan; 77.0% were serious. Data mining revealed 294 positive disproportionality signals across 27 SOCs. The highest signal proportions were for neoplasms (15.99%), musculoskeletal disorders (13.27%), infections (11.56%), gastrointestinal disorders (10.88%), and procedural complications (10.20%). The most frequent ADEs were osteonecrosis of the jaw (n = 3,082, 28.11%), death (n = 803, 7.32%), hypocalcemia (n = 799, 7.29%), and fatigue (n = 282, 2.57%). The strongest signals by ROR were bone giant cell tumor (7888.08), bone giant cell tumor malignant (6502.96), osteonecrosis of the jaw (396.57), and bone giant cell tumor benign (312.37). Thirty-two unlisted events were identified, including exostosis of jaw, osteosarcoma, tooth fracture, and bone lesions. CONCLUSIONS: Clinicians should maintain vigilance for both established toxicities and these 32 emerging signals to ensure the safety of patients receiving 120 mg of denosumab for oncological purposes.