ArticleFrontiers in pharmacology2022
Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data.
Article in Frontiers in pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 9 citations in OpenAlex.
- Pharmacovigilance and network toxicology analysis of risdiplam-associated adverse events in pediatric patients with spinal muscular atrophy.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Drug-induced gastric motility disorders: A disproportionality analysis from the FAERS and CVARD databases.PloS one · 2026Article
- Real-world safety profile of T-cell engagers: evidence from multi-database analysis with CAR-T comparisons.Frontiers in immunology · 2026Article
- Synergistic toxicity and clinical prioritization of docetaxel combined with nintedanib for non-small cell lung cancer: a real-world safety analysis using the FAERS database.Frontiers in oncology · 2026Article
- Real-world pharmacovigilance assessment of meropenem-associated adverse events: age stratification and time-to-onset analysis using FAERS.Frontiers in medicine · 2026Article
- Male sexual dysfunction associated with TNF-α inhibitors: an indication-stratified global pharmacovigilance analysis.Frontiers in pharmacology · 2026Article
- Safety profile of entrectinib in NSCLC: Multi-source pharmacovigilance analysis using FAERS and JADER.PloS one · 2026Article
- A multidimensional investigation of myelosuppression associated with sintilimab: integrating pharmacovigilance signal mining with real-world clinical evidence.Frontiers in pharmacology · 2026Article
- Real-world safety profile and mechanistic insights into regorafenib-induced liver failure: a pharmacovigilance study integrated with network toxicology.Frontiers in pharmacology · 2025Article
- The real-world safety of lacosamide and perampanel in children: a disproportionality analysis of the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2025Article
- Optimal Significance Levels and Sample Sizes for Signal Detection Methods Based on Non-constant Hazards.Drug safety · 2024Article
- Neurological and Psychiatric Adverse Events Associated with Cyclin-Dependent Kinase 4/6 Inhibitors in Breast Cancer Patients: Insights from a Pharmacovigilance Study via the FDA Adverse Event Reporting System.Clinical drug investigation · 2024Article
- Safety assessment of anti-B cell maturation antigen chimeric antigen receptor T cell therapy: a real-world study based on the FDA adverse event reporting system database.Frontiers in immunology · 2024Article
- Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.Drug safety · 2023Article
- Temporal Trends in Antineoplastic Agent-associated Interstitial Lung Disease Involving Immune Checkpoint Inhibitors in the JADER Database.In vivo (Athens, Greece)Article
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Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pharmacovigilance is the process of monitoring the emergence of harm from a medicine once it has been licensed and is in use. The aim is to identify new adverse drug reactions (ADRs) or changes in frequency of known ADRs. The last decade has seen increased interest for the use of electronic health records (EHRs) in pharmacovigilance. The causal mechanism of an ADR will often result in the occurrence being time dependent. We propose identifying signals for ADRs based on detecting a variation in hazard of an event using a time-to-event approach. Cornelius et al. proposed a method based on the Weibull Shape Parameter (WSP) and demonstrated this to have optimal performance for ADRs occurring shortly after taking treatment or delayed ADRs, and introduced censoring at varying time points to increase performance for intermediate ADRs. We now propose two new approaches which combined perform equally well across all time periods. The performance of this new approach is illustrated through an EHR Bisphosphonates dataset and a simulation study. One new approach is based on the power generalised Weibull distribution (pWSP) introduced by Bagdonavicius and Nikulin alongside an extended version of the WSP test, which includes one censored dataset resulting in improved detection across time period (dWSP). In the Bisphosphonates example, the pWSP and dWSP tests correctly signalled two known ADRs, and signal one adverse event for which no evidence of association with the drug exist. A combined test involving both pWSP and dWSP is reliable independently of the time of occurrence of ADRs.
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