Evidence map›Paper›PMID 39740919›Full record

ArticleIn vivo (Athens, Greece)

Evaluation of Lung Adverse Events Associated With Lenvatinib: A Post-marketing Surveillance Study.

Yuko Kanbayashi, Yuki Kaneko, Momoko Kobayashi, Haruka Wakabayashi, Tadashi Shimizu, Mayako Uchida

Abstract read
In one paragraph

Article in In vivo (Athens, Greece). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. 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.

Yuko KanbayashiDepartment of Education and Research Center for Clinical Pharmacy, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, Japan; yuko.kambayashi@ompu.ac.jp.
Yuki KanekoDepartment of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Japan.
Momoko KobayashiDepartment of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Japan.
Haruka WakabayashiDepartment of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Japan.
Tadashi ShimizuSchool of Pharmacy, Hyogo Medical University, Kobe, Japan.
Mayako UchidaDepartment of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimDespite the seriousness of lung adverse events (AEs) associated with lenvatinib, comprehensive data on these events remain limited. This study was conducted to examine the disproportionality, time to onset, incidence rates, and outcomes of lenvatinib-associated lung AEs using the Japanese Adverse Drug Event Report database. PATIENTS AND

methodsWe analysed data for the period from April 2004 to May 2023. Data on lung AEs were extracted and the relative disproportionality of AEs was estimated using reporting odds ratios (RORs). Weibull distribution parameters were also calculated.

resultsAmong the 2,230,863 reports analysed, 7,684 reports of AEs associated with lenvatinib were identified, including 380 lung AEs. Signals were detected for three lung AEs: tracheal fistula, tracheo-oesophageal fistula, and tracheal haemorrhage. Fatal outcomes were observed for tracheal fistula and tracheal haemorrhage. A histogram of median times to onset indicated that lung AEs associated with lenvatinib occurred 15-111 days after administration. Weibull distributions showed that the incidence of these AEs remained constant throughout the exposure period (random failure type).

conclusionThe present study highlights post-marketing AEs associated with lenvatinib, with a particular focus on lung AEs. Tracheal fistula and tracheal haemorrhage were identified as AEs with potentially serious outcomes following lenvatinib administration. Monitoring patients for early signs of these AEs is important not only at treatment initiation, but also throughout the entire course of therapy.

Indexed as

Phenylurea CompoundsProduct Surveillance, PostmarketingQuinolinesAdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overAntineoplastic AgentsDatabases, FactualDrug-Related Side Effects and Adverse ReactionsFemaleHumansIncidenceJapanLungLung DiseasesAntineoplastic AgentslenvatinibPhenylurea CompoundsQuinolinesJapanese Adverse Drug Reaction Reporting databaseLenvatiniblung adverse eventoutcometime to onset

Identifiers

PMID39740919
PMCPMC11705116

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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.