Evidence map›Paper›PMID 38762672›Full record

ArticleScientific reports2024

A real-world pharmacovigilance study of FDA adverse event reporting system events for Capmatinib.

Yiming Qi, Jing Li, Sisi Lin, Shuangshuang Wu, Kequn Chai, Xin Jiang, Jiancheng Qian, Cheng Jiang

Abstract read
In one paragraph

Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

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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

8 authors.

Yiming Qi *Tongde Hospital Affiliated to Zhejiang Chinese Medical University (Tongde Hospital of Zhejiang Province), No. 234, Gucui Road, Hangzhou, 310012, Zhejiang, China.
Jing Li *Tongde Hospital Affiliated to Zhejiang Chinese Medical University (Tongde Hospital of Zhejiang Province), No. 234, Gucui Road, Hangzhou, 310012, Zhejiang, China.
Sisi LinDepartment of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325000, Zhejiang, China.
Shuangshuang WuTongde Hospital Affiliated to Zhejiang Chinese Medical University (Tongde Hospital of Zhejiang Province), No. 234, Gucui Road, Hangzhou, 310012, Zhejiang, China.
Kequn ChaiTongde Hospital Affiliated to Zhejiang Chinese Medical University (Tongde Hospital of Zhejiang Province), No. 234, Gucui Road, Hangzhou, 310012, Zhejiang, China.
Xin JiangWenling Hospital of Traditional Chinese Medicine Affiliated to Zhejiang, Chinese Medical University, Wenling, 317500, Zhejiang, China.
Jiancheng QianTongde Hospital Affiliated to Zhejiang Chinese Medical University (Tongde Hospital of Zhejiang Province), No. 234, Gucui Road, Hangzhou, 310012, Zhejiang, China. key.i@163.com.
Cheng JiangTongde Hospital Affiliated to Zhejiang Chinese Medical University (Tongde Hospital of Zhejiang Province), No. 234, Gucui Road, Hangzhou, 310012, Zhejiang, China. jiangcheng0818@126.com.

Funding

Basic Public Welfare Research Program of Zhejiang Province Q23H280033Basic Public Welfare Research Program of Zhejiang Province Q24H290032Traditional Chinese Medicine Science and Technology Project of Zhejiang Province 2024ZF004Traditional Chinese Medicine Science and Technology Project of Zhejiang Province 2024ZL362Wenling Social Development Science and Technology Project 2021S00108
6 · The paper itself

Abstract

Capmatinib is a potent selective mesenchymal-epithelial transition inhibitor approved in 2020 for the treatment of metastatic non-small cell lung cancer. As real-world evidence is very limited, this study evaluated capmatinib-induced adverse events through data mining of the FDA Adverse Event Reporting System database. Four disproportionality analysis methods were employed to quantify the signals of capmatinib-related adverse events. The difference in capmatinib-associated adverse event signals was further investigated with respect to sex, age, weight, dose, onset time, continent, and concomitant drug. A total of 1518 reports and 4278 adverse events induced by capmatinib were identified. New significant adverse event signals emerged, such as dysphagia, dehydration, deafness, vocal cord paralysis, muscle disorder, and oesophageal stenosis. Notably, higher risk of alanine aminotransferase and aspartate aminotransferase increases were observed in females, especially when capmatinib was combined with immune checkpoint inhibitors. Compared with Europeans and Asians, Americans were more likely to experience peripheral swelling, especially in people > 65 years of age. Renal impairment and increased blood creatinine were more likely to occur with single doses above 400 mg and in Asians. This study improves the understanding of safety profile of capmatinib.

Indexed as

Adverse Drug Reaction Reporting SystemsBenzamidesPharmacovigilanceUnited States Food and Drug AdministrationAdolescentAdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungFemaleHumansImidazolesLung NeoplasmsMaleMiddle AgedTriazinesBenzamidescapmatinibImidazolesTriazines

Identifiers

PMID38762672
PMCPMC11102445

What OpenQuestion holds

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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.