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Ear and labyrinth toxicities induced by immune checkpoint inhibitors: a disproportionality analysis from 2014 to 2019.
- Source :
-
Immunotherapy [Immunotherapy] 2020 May; Vol. 12 (7), pp. 531-540. Date of Electronic Publication: 2020 May 27. - Publication Year :
- 2020
-
Abstract
- 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 (ROR <subscript>025</subscript> : 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.
- Subjects :
- Adverse Drug Reaction Reporting Systems statistics & numerical data
Drug-Related Side Effects and Adverse Reactions epidemiology
Drug-Related Side Effects and Adverse Reactions etiology
Female
Humans
Immunotherapy adverse effects
Male
Ototoxicity epidemiology
United States epidemiology
United States Food and Drug Administration statistics & numerical data
Immune Checkpoint Inhibitors adverse effects
Ototoxicity etiology
Subjects
Details
- Language :
- English
- ISSN :
- 1750-7448
- Volume :
- 12
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Immunotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 32456497
- Full Text :
- https://doi.org/10.2217/imt-2019-0120