Evidence map›Paper›PMID 40846919›Full record

ArticleBMC cancer2025

Osimertinib-related myotoxicity: a disproportionality analysis of the FDA adverse event reporting system.

Yaqian Tan, Qi Song

Abstract read
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Article
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

2 authors.

Yaqian TanDepartment of Pharmacy, The Affiliated Brain Hospital, Guangzhou Medical University, Mingxin Road 36, Liwan District, Guangzhou, 510370, China. tanyaqian2013@163.com.
Qi SongDepartment of Pharmacy, Guangzhou Institute of Cancer Research, the Affiliated Cancer Hospital, Guangzhou Medical University, Guangzhou, China.

Funding

Basic and Applied Basic Research Foundation of Guangdong Province 2020A1515110008Guangzhou Municipal Key Discipline in Medicine 2025-2027Guangzhou Municipal Science and Technology Project 202102021022, 2023A04J0601, 2024A04J10001, and 2025A03J3308Guangzhou Municipal Science and Technology Project for Medicine and Healthcare 20211A011044National Natural Science Foundation of China 82104223 and 82204372
6 · The paper itself

Abstract

backgroundOsimertinib is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor that has been widely applied as a standard first-line treatment in advanced non-small cell lung cancer. However, the risk signals of osimertinib-related myotoxicity have not yet been fully examined. This study aimed to explore osimertinib-related myotoxicity by conducting a real-world disproportionality analysis.

methodsData from January 1st 2015 to March 31st 2024 were retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System database. Reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) were employed to perform disproportionality analysis.

resultsA total of 121 cases with osimertinib-related myotoxicity were identified and analyzed. The adverse events were mostly reported in females (n = 74, 61.2%) and patients aged over 65 years old (n = 56, 46.3%). The median value of adverse event onset time was 40 (13.3, 164.5). Disproportionality analysis revealed that blood creatine phosphokinase increased (ROR

conclusionsOur study comprehensively revealed the safety characteristics of osimertinib-associated myotoxicity. The results would offer referable evidence on the safety and prognosis of osimertinib.

Indexed as

AcrylamidesAdverse Drug Reaction Reporting SystemsAniline CompoundsAntineoplastic AgentsCarcinoma, Non-Small-Cell LungLung NeoplasmsMuscular DiseasesProtein Kinase InhibitorsAdultAgedAged, 80 and overFemaleHumansIndolesMaleMiddle AgedAcrylamidesAniline CompoundsAntineoplastic AgentsIndolesosimertinibProtein Kinase InhibitorsPyrimidinesAdverse eventFAERSMyotoxicityOsimertinibPharmacovigilance

Identifiers

PMID40846919
PMCPMC12374422

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Registered trials

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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 OpenQuestion graph.