Evidence mapPaperPMID 42490993Full record

ArticleAlzheimer's & dementia (Amsterdam, Netherlands)

Real-world pharmacovigilance for anti-Aβ therapies using a large language model.

Allan Fong, Azade Tabaie, Samantha Paylor, Tien Tran, Rabbiya Iqbal, Raj M Ratwani, Zafar Zafari, Lauren R Bangerter, Nicole J Brandt

Abstract read
In one paragraph

Article in Alzheimer's & dementia (Amsterdam, Netherlands). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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

9 authors.

Allan FongCenter for Biostatistics, Informatics, and Data Science MedStar Health Research Institute, MedStar Health Washington District of Columbia USA.ORCID https://orcid.org/0000-0002-7550-1569
Azade TabaieCenter for Biostatistics, Informatics, and Data Science MedStar Health Research Institute, MedStar Health Washington District of Columbia USA.
Samantha PaylorUniversity of Maryland School of Pharmacy Baltimore Maryland USA.
Tien TranUniversity of Maryland School of Pharmacy Baltimore Maryland USA.
Rabbiya IqbalGeorgetown University School of Medicine Washington District of Columbia USA.
Raj M RatwaniMedStar Health Research Institute-National Center for Human Factors in Healthcare Washington District of Columbia USA.
Zafar ZafariUniversity of Maryland School of Pharmacy Baltimore Maryland USA.
Lauren R BangerterMedStar Health Research Institute-National Center for Human Factors in Healthcare Washington District of Columbia USA.
Nicole J BrandtUniversity of Maryland School of Pharmacy Baltimore Maryland USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAnti-amyloid beta (Aβ) therapies for early Alzheimer's disease require enhanced safety monitoring, yet adverse event (AE) documentation is diffuse across heterogeneous electronic health record documents. Large language models (LLMs) may improve scalable pharmacovigilance.

methodsWe analyzed 20,123 clinical documents from 46 patients who received at least one dose of anti-Aβ therapy (June 24, 2024-July 30, 2025) at a large mid-Atlantic health-care system. We compared standard expert review versus an LLM-augmented workflow applied to the same documents. Expert reviewers annotated therapy-related AEs (e.g., amyloid-related imaging abnormalities with edema or hemorrhage, headache, syncope, hypersensitivity, gastrointestinal symptoms, infusion reactions). Discordant cases were adjudicated to establish a reference label.

resultsAfter adjudication, 76% (35/46) patients had an AE. The LLM-augmented workflow achieved 100% sensitivity (positive predictive value [PPV] 89.7%) versus expert review 88.6% sensitivity (PPV 100%). DISCUSSION: Findings provide preliminary indications that LLMs may serve as a pharmacovigilance signal detection tool, with a need for further validation and evaluation of clinical integration.

Indexed as

adverse event detectionanti‐amyloid therapyelectronic health recordslarge language modelspharmacovigilance

Identifiers

PMID42490993
PMCPMC13375930

What Socratic holds

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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 Socratic graph.