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Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS
Objective: Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm the platinum agent-associated mild, severe, and lethal hypersensitivity reactions. Methods: Authorized pharmacovigilance tools were used for quantitative signal detection, includin...
Autores principales: | , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
Ivyspring International Publisher
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3100741/ https://www.ncbi.nlm.nih.gov/pubmed/21611115 |
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author | Sakaeda, Toshiyuki Kadoyama, Kaori Yabuuchi, Hiroaki Niijima, Satoshi Seki, Kyoko Shiraishi, Yukinari Okuno, Yasushi |
author_facet | Sakaeda, Toshiyuki Kadoyama, Kaori Yabuuchi, Hiroaki Niijima, Satoshi Seki, Kyoko Shiraishi, Yukinari Okuno, Yasushi |
author_sort | Sakaeda, Toshiyuki |
collection | PubMed |
description | Objective: Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm the platinum agent-associated mild, severe, and lethal hypersensitivity reactions. Methods: Authorized pharmacovigilance tools were used for quantitative signal detection, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Excess2, given by the multi-item gamma Poisson Shrinker algorithm, was used to evaluate the effects of dexamethasone and diphenhydramine on oxaliplatin-induced hypersensitivity reactions. Results: Based on 1,644,220 AERs from 2004 to 2009, carboplatin and oxaliplatin proved to cause mild, severe, and lethal hypersensitivity reactions, whereas cisplatin did not. Dexamethasone affected oxaliplatin-induced mild hypersensitivity reactions, but had lesser effects on severe and lethal reactions. The effects of diphenhydramine were not confirmed. Conclusion: The FDA's adverse event reporting system, AERS, with optimized data mining tools is useful to authorize potential associations between platinum agents and hypersensitivity reactions. |
format | Text |
id | pubmed-3100741 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Ivyspring International Publisher |
record_format | MEDLINE/PubMed |
spelling | pubmed-31007412011-05-24 Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS Sakaeda, Toshiyuki Kadoyama, Kaori Yabuuchi, Hiroaki Niijima, Satoshi Seki, Kyoko Shiraishi, Yukinari Okuno, Yasushi Int J Med Sci Research Paper Objective: Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm the platinum agent-associated mild, severe, and lethal hypersensitivity reactions. Methods: Authorized pharmacovigilance tools were used for quantitative signal detection, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Excess2, given by the multi-item gamma Poisson Shrinker algorithm, was used to evaluate the effects of dexamethasone and diphenhydramine on oxaliplatin-induced hypersensitivity reactions. Results: Based on 1,644,220 AERs from 2004 to 2009, carboplatin and oxaliplatin proved to cause mild, severe, and lethal hypersensitivity reactions, whereas cisplatin did not. Dexamethasone affected oxaliplatin-induced mild hypersensitivity reactions, but had lesser effects on severe and lethal reactions. The effects of diphenhydramine were not confirmed. Conclusion: The FDA's adverse event reporting system, AERS, with optimized data mining tools is useful to authorize potential associations between platinum agents and hypersensitivity reactions. Ivyspring International Publisher 2011-05-21 /pmc/articles/PMC3100741/ /pubmed/21611115 Text en © Ivyspring International Publisher. This is an open-access article distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by-nc-nd/3.0/). Reproduction is permitted for personal, noncommercial use, provided that the article is in whole, unmodified, and properly cited. |
spellingShingle | Research Paper Sakaeda, Toshiyuki Kadoyama, Kaori Yabuuchi, Hiroaki Niijima, Satoshi Seki, Kyoko Shiraishi, Yukinari Okuno, Yasushi Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS |
title | Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS |
title_full | Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS |
title_fullStr | Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS |
title_full_unstemmed | Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS |
title_short | Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS |
title_sort | platinum agent-induced hypersensitivity reactions: data mining of the public version of the fda adverse event reporting system, aers |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3100741/ https://www.ncbi.nlm.nih.gov/pubmed/21611115 |
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