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Inferring adverse events (AEs) of medical products from Spontaneous Reporting Systems (SRS) databases is a core challenge in contemporary pharmacovigilance. Bayesian methods for pharmacovigilance are attractive for their rigorous ability to…

Methodology · Statistics 2025-02-17 Yihao Tan , Marianthi Markatou , Saptarshi Chakraborty

The vaccine adverse event reporting system (VAERS) is a vital resource for post-licensure vaccine safety monitoring and has played a key role in assessing the safety of COVID-19 vaccines. However it is difficult to properly identify rare…

Methodology · Statistics 2023-06-06 Ali Turfah , Xiaoquan Wen , Lili Zhao

It has been demonstrated that acoustic-emission (AE), inspection of structures can offer advantages over other types of monitoring techniques in the detection of damage; namely, an increased sensitivity to damage, as well as an ability to…

Applications · Statistics 2023-12-12 C. A. Lindley , M. R. Jones , T. J. Rogers , E. J. Cross , R. S. Dwyer-Joyce , N. Dervilis , K. Worden

Postmarketing safety surveillance relies on data from spontaneous reporting systems (SRS) such as FAERS, EudraVigilance and VigiBase, and commonly uses SRS data mining methods to assess the associations between drugs and adverse events…

Applications · Statistics 2026-04-29 Yihao Tan , Marianthi Markatou , Saptarshi Chakraborty

Post--marketing pharmacovigilance is essential for identifying adverse drug reactions (ADRs) that elude detection during pre--marketing clinical trials. This study explores a novel approach that integrates an adverse event (AE) ontology…

Despite extensive safety assessments of drugs prior to their introduction to the market, certain adverse drug reactions (ADRs) remain undetected. The primary objective of pharmacovigilance is to identify these ADRs (i.e., signals). In…

Methodology · Statistics 2024-04-23 Louis Dijkstra , Tania Schink , Ronja Foraita

Adverse drug reactions (ADRs) are big concern for public health. ADRs are one of most common causes to withdraw some drugs from markets. Now two major methods for detecting ADRs are spontaneous reporting system (SRS), and prescription event…

Computational Engineering, Finance, and Science · Computer Science 2013-09-02 Yihui Liu , Uwe Aickelin

The mining of adverse drug events (ADEs) is pivotal in pharmacovigilance, enhancing patient safety by identifying potential risks associated with medications, facilitating early detection of adverse events, and guiding regulatory…

Artificial Intelligence · Computer Science 2024-10-04 Pranab Sahoo , Ayush Kumar Singh , Sriparna Saha , Aman Chadha , Samrat Mondal

Data-mining techniques have frequently been developed for Spontaneous reporting databases. These techniques aim to find adverse drug events accurately and efficiently. Spontaneous reporting databases are prone to missing information, under…

Computational Engineering, Finance, and Science · Computer Science 2013-07-04 Jenna Reps , Jan Feyereisl , Jonathan M. Garibaldi , Uwe Aickelin , Jack E. Gibson , Richard B. Hubbard

Adverse drug reactions / events (ADR/ADE) have a major impact on patient health and health care costs. Detecting ADR's as early as possible and sharing them with regulators, pharma companies, and healthcare providers can prevent morbidity…

Computation and Language · Computer Science 2022-01-07 Hasham Ul Haq , Veysel Kocaman , David Talby

We present a graphical, knowledge-based method for reviewing treatment-emergent adverse events (AEs) in clinical trials. The approach enhances MedDRA by adding a hidden medical knowledge layer (Safeterm) that captures semantic relationships…

Computation and Language · Computer Science 2025-11-25 Francois Vandenhende , Anna Georgiou , Michalis Georgiou , Theodoros Psaras , Ellie Karekla , Elena Hadjicosta

Meta-analysis is a powerful tool for assessing drug safety by combining treatment-related toxicological findings across multiple studies, as clinical trials are typically underpowered for detecting adverse drug effects. However, incomplete…

Statistical agencies and other institutions collect data under the promise to protect the confidentiality of respondents. When releasing microdata samples, the risk that records can be identified must be assessed. To this aim, a widely…

Applications · Statistics 2015-06-03 Cinzia Carota , Maurizio Filippone , Roberto Leombruni , Silvia Polettini

Adverse drug interactions are a critical concern in pharmacovigilance, as both clinical trials and spontaneous reporting systems often lack the breadth to detect complex drug interactions. This study introduces a computational framework for…

Applications · Statistics 2025-04-02 Jules Bangard , Einar Holsbø , Kristian Svendsen , Vittorio Perduca , Etienne Birmelé

Adverse Drug Reaction (ADR) is a significant public health concern world-wide. Numerous graph-based methods have been applied to biomedical graphs for predicting ADRs in pre-marketing phases. ADR detection in post-market surveillance is no…

Machine Learning · Computer Science 2020-04-02 Heeyoung Kwak , Minwoo Lee , Seunghyun Yoon , Jooyoung Chang , Sangmin Park , Kyomin Jung

Automatic monitoring of adverse drug events (ADEs) or reactions (ADRs) is currently receiving significant attention from the biomedical community. In recent years, user-generated data on social media has become a valuable resource for this…

Computation and Language · Computer Science 2023-11-21 Ilseyar Alimova , Elena Tutubalina

We introduce a Bayesian nonparametric inference approach for aggregate adverse event (AE) monitoring across studies. The proposed model seamlessly integrates external data from historical trials to define a relevant background rate and…

Methodology · Statistics 2025-09-10 Shijie Yuan , Kevin Roberts , Noirrit Kiran Chandra , Yuan Ji , Peter Müller

Adverse drug events (ADEs) are an important aspect of drug safety. Various texts such as biomedical literature, drug reviews, and user posts on social media and medical forums contain a wealth of information about ADEs. Recent studies have…

Computation and Language · Computer Science 2024-05-21 Shaoxiong Ji , Ya Gao , Pekka Marttinen

We present a Bayesian dynamic borrowing (BDB) approach to enhance the quantitative identification of adverse events (AEs) in spontaneous reporting systems (SRSs). The method embeds a robust meta-analytic predictive (MAP) prior with a…

Computation and Language · Computer Science 2025-05-20 François Haguinet , Jeffery L Painter , Gregory E Powell , Andrea Callegaro , Andrew Bate

Active adverse event surveillance monitors Adverse Drug Events (ADE) from different data sources, such as electronic health records, medical literature, social media and search engine logs. Over the years, many datasets have been created,…

Computation and Language · Computer Science 2024-11-26 Xiang Dai , Sarvnaz Karimi , Abeed Sarker , Ben Hachey , Cecile Paris
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