Evidence map›Paper›PMID 40542371›Full record

ArticleOrphanet journal of rare diseases2025

Toxicity spectrum of pegvaliase: A pharmacovigilance analysis using the FAERS database.

Luyao Xu, Kaili Mao, Songyang Zhong, Huayu Sun, Hongliang Zheng, Zhenling Fu

Abstract read
In one paragraph

Article in Orphanet journal of rare diseases, 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

6 authors.

Luyao XuDepartment of Pharmacy, The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou People's Hospital, No.100 Minjiang Road, Kecheng District, Quzhou, 324000, Zhejiang, China.
Kaili MaoDepartment of Pharmacy, The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou People's Hospital, No.100 Minjiang Road, Kecheng District, Quzhou, 324000, Zhejiang, China.
Songyang ZhongDepartment of Pharmacy, The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou People's Hospital, No.100 Minjiang Road, Kecheng District, Quzhou, 324000, Zhejiang, China.
Huayu SunDepartment of Pharmacy, The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou People's Hospital, No.100 Minjiang Road, Kecheng District, Quzhou, 324000, Zhejiang, China.
Hongliang ZhengDepartment of Pharmacy, The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou People's Hospital, No.100 Minjiang Road, Kecheng District, Quzhou, 324000, Zhejiang, China.
Zhenling FuDepartment of Pharmacy, The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou People's Hospital, No.100 Minjiang Road, Kecheng District, Quzhou, 324000, Zhejiang, China. 276784489@qq.com.ORCID http://orcid.org/0000-0003-1875-8162

Funding

Quzhou Municipal Science and Technology Bureau 2023K141
6 · The paper itself

Abstract

objectiveThis research aimed to assess the safety of pegvaliase through analyzed the data from the FAERS database, thus providing a theoretical foundation for the rational and safe application of pegvaliase in clinical settings.

methodsPegvaliase-associated adverse event reports were searched in FAERS database from the 2018 Q3 to 2023 Q2. These data were further mined through Four different algorithms, including ROR, PRR, BCPNN, and EBGM.

resultsA total of 5,076 AEs reports were obtained from the FAERS database. At the PTs level, it was discovered that AE reports associated with pegvaliase as the primary suspect were connected to the 27 SOCs. Among these PTs, 83 signals in total were found, and each of them concurrently complied with the four algorithms. Further, we ranked PTs first for arthralgia in order of frequency and first for decreased amino acid levels in order of signal intensity. The median time to onset of adverse reactions was 15 days.

conclusionWe mined and analyzed the AE signals of pegvaliase based on the FAERS database, it turned out that they were generally consistent with the drug inserts and clinical trial results. However, potential new AE signals were revealed, providing a basis for the identification of adverse reactions in the clinical setting.

Indexed as

AsparaginaseAlgorithmsDatabases, FactualFemaleHumansMalePharmacovigilanceAsparaginaseAdverse eventData miningFAERS databasePegvaliasePharmacovigilance

Identifiers

PMID40542371
PMCPMC12181874

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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.