Introduction: existing research on children consists primarily of phase I/II clinical trials for VEGFR-TKI. System reports of safety on the use of VEGFR-TKI in pediatrics are lacking.Aim: to investigate the safety profiles of VEGFR-TKI in pediatrics via the FDA Adverse Event Reporting System (FAERS).Method: data regarding VEGFR-TKIs were extracted from the FAERS between 2004Q1 to 2022Q3 and categorized by the Medical Dictionary for Regulatory Activities (MedDRA). Population characteristics were analyzed, and reporting odds ratio (ROR) was performed to identify risk signals associated with VEGFR-TKI.Results: 53,921 cases containing 561 children were identified in the database from 18 May 2005, to 30 September 2022. Among those in the system organ class, skin, subcutaneous tissue disorders, and blood and lymphatic system disorders in pediatrics contributed to over 140 cases. Palmar-plantar eythrodysesthesia syndrome (PPES) in VEGFR-TKI presented the most significant 340.9 (95% 229.2–507.0). And pneumothorax also gave a high reporting odds ratio of 48.9 (95% 34.7–68.9). For a specific drug, musculoskeletal pain gave a ROR of 78.5 (95% 24.4–252.6) in cabozantinib and oesophagitis in lenvatinib with a ROR of 95.2 (95% 29.5–306.9). Additionally, hypothyroidism presented a high signal, especially sunitinib, with a ROR of 107.8 (95% 37.6–308.7).Conclusion: the present study explored the safety profile of VEGFR-TKI in pediatrics using the FAERS database. Multiple skin and subcutaneous tissue disorders, as well as blood and lymphatic system disorders, were common VEGFR-TKI-related AEs in system organ class. No serious hepatobiliary AEs were detected. For the specific AEs, PPES and pneumothorax were VEGFR-TKI-related AEs that presented significantly higher signals than those in the general population.
Background: Existing research focuses primarily on common adverse events (AEs) in adults using Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI), systematic reports from real-world settings and safety research on off-label use in children are lacking. Therefore, we aimed to investigate the safety profiles of VEGFR-TKIs via the FAERS. Method: Data regarding VEGFR-TKIs were extracted from the FAERS between 2004Q1 to 2022Q2. Reporting odds ratio (ROR) was performed to identify risk signals associations of VEGFR-TKIs with AEs. A reported AE would be defined as a potential risk signal if it simultaneously met the report cases ≥ 3, ROR ≥ 2, the lower limit of 95% CI ≥1, and χ2 ≥ 4. and categorized by the MedDRA terms. Results: A total of 51,841 reports containing 536 children were identified from May 18, 2005, to June 30, 2022. Despite some differences, 7 VEGFR-TKIs had similar safety profiles in the general population. The most significant ROR was PPES and the most frequent SOC was gastrointestinal disorders. In pediatrics, results varied in these agents, and the most frequent AE with significant ROR were PPES, followed by pneumothorax. Furthermore, blood and lymphatic system disorders and investigation abnormalities were both the most common SOCs. Conclusion: Disproportionality analysis based on the FAERS database is an effective path to recognize VEGFR-TKI-related AEs. Findings of the general population were largely consistent with real-world setting studies, and the widely recorded data in FAERS also made it possible to retrieve the safety of these agents in pediatrics.
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