Evidence map›Paper›PMID 42379740›Full record

ArticleIn vivo (Athens, Greece)

Adverse Event Profiling and Comparative Analysis of HER2-targeting Antibody-drug Conjugates Using Pharmacovigilance Databases.

Kousuke Hosonaka, Kenta Yamaoka, Mayako Uchida, Yoshihiro Uesawa, Kazushige Takahashi, Tadashi Shimizu

Abstract read
PubMed Full text at PMC Publisher
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 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.

Kousuke HosonakaSchool of Pharmacy, Hyogo Medical University, Kobe, Japan.
Kenta YamaokaSchool of Pharmacy, Hyogo Medical University, Kobe, Japan.
Mayako UchidaDepartment of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
Yoshihiro UesawaDepartment of Medical Molecular Informatics, Meiji Pharmaceutical University, Tokyo, Japan.
Kazushige TakahashiDepartment of Pharmacy, Osaka-fu Saiseikai Noe Hospital, Osaka, Japan.
Tadashi ShimizuSchool of Pharmacy, Hyogo Medical University, Kobe, Japan; shimizu-t@hyo-med.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimAnti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugates have incompletely characterized safety profiles. Therefore, we compared the adverse events for trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd) using the Japanese Adverse Drug Event Report (JADER) database and U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). PATIENTS AND

methodsWe analyzed the JADER (April 2004-April 2025) and FAERS (Q1 1997-Q1 2025) databases for the target drugs T-DM1 and T-DXd, with trastuzumab and pertuzumab as comparators. All reported cases were included regardless of severity grade.

resultsHepatobiliary disorder signals were detected for T-DM1, whereas hematotoxicity- and infection-related signals were prominent for T-DXd, including sepsis and

conclusionAnalyses using JADER and FAERS revealed the adverse event profiles of HER2 antibody-drug conjugates. Hepatobiliary disorders were characteristic of T-DM1, whereas hematotoxicity and infection-related events were characteristic of T-DXd. Interstitial lung disease was detected for both agents. These findings were consistent with those of clinical trials. Infection-related events associated with T-DXd were identified as potential signals, highlighting the clinical relevance of PJP, with a median time to onset of approximately 90 days.

Indexed as

Antineoplastic Agents, ImmunologicalDrug-Related Side Effects and Adverse ReactionsErb-b2 Receptor Tyrosine KinasesImmunoconjugatesPharmacovigilanceAdo-Trastuzumab EmtansineAdultAdverse Drug Reaction Reporting SystemsAgedAntibodies, Monoclonal, HumanizedCamptothecinDatabases, FactualFemaleHumansMaleMiddle AgedAdo-Trastuzumab EmtansineAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatespertuzumabTrastuzumabtrastuzumab deruxtecanAntibody-drug conjugatedisproportionality analysisJapanese Adverse Drug Event Reportpharmacovigilancetrastuzumab deruxtecantrastuzumab emtansine

Identifiers

PMID42379740
PMCPMC13321999

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.