Evidence map›Paper›PMID 41692910›Full record

ArticleScientific reports2026

A kNN based machine learning approach to automating causality assessment of adverse events.

Jun Ren, Hua Carroll, Kerry McCarthy, Jeff Allen, Jeff Tam, Jeffrey Philip, Monica Mehta, Douglas Clark

Abstract read
In one paragraph

Article in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Jun RenTechnology, Analytics & Data Insights (TADI), Biogen, Cambridge, MA, 02142, USA. jun.ren@biogen.com.
Hua CarrollGlobal PV, Reg Submissions Mgt, PV/Reg Quality, Biogen, Cambridge, MA, 02142, USA.
Kerry McCarthyGlobal PV, Reg Submissions Mgt, PV/Reg Quality, Biogen, Cambridge, MA, 02142, USA.
Jeff AllenTechnology, Analytics & Data Insights (TADI), Biogen, Cambridge, MA, 02142, USA.
Jeff TamTechnology, Analytics & Data Insights (TADI), Biogen, Cambridge, MA, 02142, USA.
Jeffrey PhilipTechnology, Analytics & Data Insights (TADI), Biogen, Cambridge, MA, 02142, USA.
Monica MehtaGlobal PV, Reg Submissions Mgt, PV/Reg Quality, Biogen, Cambridge, MA, 02142, USA.
Douglas ClarkTechnology, Analytics & Data Insights (TADI), Biogen, Cambridge, MA, 02142, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This paper introduces a machine learning classifier designed to automate causality assessment in Individual Case Safety Reports (ICSRs), utilizing the principle of event similarity. The classifier’s effectiveness was evaluated using adverse events from six marketed products. Furthermore, we incorporated an augmentation tool to efficiently manage the classification of ‘unassessable’ adverse events. To enhance medical review oversight, we developed a web-based application serving as a reliable decision-support tool for medical reviewers. The outcomes obtained from our model were highly encouraging, emphasizing the potential advantages of utilizing such a model in ICSR causality assessment.

Indexed as

Causality AssessmentICSRMachine LearningPharmacovigilanceSimilarity

Identifiers

PMID41692910
PMCPMC12996322

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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 OpenQuestion graph.