Aim: We aimed to systematically characterize ear and labyrinth toxicities after immune checkpoint inhibitors (ICIs) initiation. Materials & methods: Data were extracted from the US FDA Adverse Event Reporting System database. Disproportionality analysis including information component and reporting odds ratio (ROR) was performed to access potential signals. Results: In FDA Adverse Event Reporting System database, 284 records for ICIs-associated ear/labyrinth adverse events (AEs) were involved. In general, there was no significant association between total ICIs use and total ear and labyrinth AEs (ROR025: 0.576). However, in ICIs monotherapy and polytherapy groups, signals were detected in several specific ear and labyrinth AEs. Conclusion: Total ear and labyrinth toxicities were not significantly reported with ICI immunotherapy, while class-specific ear toxicities were detected in some strategies.

中文翻译：

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免疫检查点抑制剂引起的耳和迷路毒性：2014 年至 2019 年的不成比例分析。

目的：我们旨在系统地表征免疫检查点抑制剂 (ICI) 启动后的耳部和迷路毒性。材料和方法：数据来自美国 FDA 不良事件报告系统数据库。执行包括信息成分和报告优势比 (ROR) 在内的不成比例分析以获取潜在信号。结果：在 FDA 不良事件报告系统数据库中，涉及 ICI 相关耳/迷路不良事件 (AE) 的 284 条记录。一般而言，总 ICI 使用与总耳道和迷路 AE 之间没有显着关联（ROR025：0.576）。然而，在 ICI 单药治疗和多药治疗组中，在几个特定的​​耳部和迷路 AE 中检测到信号。结论：使用 ICI 免疫疗法没有显着报告总耳和迷路毒性，