Evidence map›Paper›PMID 21611115›Full record

ArticleInternational journal of medical sciences2011

Platinum agent-induced hypersensitivity reactions: data mining of the public version of the FDA adverse event reporting system, AERS.

Toshiyuki Sakaeda, Kaori Kadoyama, Hiroaki Yabuuchi, Satoshi Niijima, Kyoko Seki, Yukinari Shiraishi, Yasushi Okuno

Open access · goldAbstract read
In one paragraph

Article in International journal of medical sciences, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
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  15. Carboplatin-induced hypersensitivity reaction.Case reports in oncology · 2012
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Toshiyuki SakaedaCenter for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan. sakaedat@pharm.kyoto-u.ac.jp
Kaori Kadoyama
Hiroaki Yabuuchi
Satoshi Niijima
Kyoko Seki
Yukinari Shiraishi
Yasushi Okuno
Kyoto University · JPKobe Rosai Hospital · JPKyoto Pharmaceutical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAdverse 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.

methodsAuthorized 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.

resultsBased 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.

conclusionThe FDA's adverse event reporting system, AERS, with optimized data mining tools is useful to authorize potential associations between platinum agents and hypersensitivity reactions.

Indexed as

Adverse Drug Reaction Reporting SystemsAntineoplastic AgentsBayes TheoremCarboplatinCisplatinDatabases, FactualData MiningDexamethasoneDiphenhydramineDrug HypersensitivityDrug Therapy, CombinationHumansOrganoplatinum CompoundsOxaliplatinUnited StatesUnited States Food and Drug AdministrationAntineoplastic AgentsCarboplatinCisplatinDexamethasoneDiphenhydramineOrganoplatinum CompoundsOxaliplatinadverse eventAERShypersensitivityplatinum agent

Identifiers

PMID21611115
PMCPMC3100741
OpenAlexW2167352770

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.