ArticleTherapeutic advances in drug safety2017
The impact of database restriction on pharmacovigilance signal detection of selected cancer therapies.
Article in Therapeutic advances in drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- Disproportionality analysis of interstitial lung disease associated with novel antineoplastic agents during breast cancer treatment: a pharmacovigilance study.EClinicalMedicine · 2025Article
- Disproportionality Analysis and Causal Inference in Drug Safety.Pharmaceutical medicine · 2025Review
- Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis.Drug safety · 2024Article
- Emerging Toxicities of Antibody-Drug Conjugates for Breast Cancer: Clinical Prioritization of Adverse Events from the FDA Adverse Event Reporting System.Targeted oncology · 2024Article
- The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies.American journal of epidemiology · 2024Review
- A bibliometric analysis of research progress on pharmacovigilance and cancer from 2002 to 2021.Frontiers in oncology · 2023Review
- Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.Frontiers in drug safety and regulation · 2023Review
- Analysis of pharmacovigilance databases for spontaneous reports of adverse drug reactions related to substandard and falsified medical products: A descriptive study.Frontiers in pharmacology · 2022Article
- Cyclin-dependent kinase 4/6 inhibitors and interstitial lung disease in the FDA adverse event reporting system: a pharmacovigilance assessment.Breast cancer research and treatment · 2021Article
- Lessons to be Learnt from Real-World Studies on Immune-Related Adverse Events with Checkpoint Inhibitors: A Clinical Perspective from Pharmacovigilance.Targeted oncology · 2020Review
- Toxicities with Immune Checkpoint Inhibitors: Emerging Priorities From Disproportionality Analysis of the FDA Adverse Event Reporting System.Targeted oncology · 2019Observational
- Evaluation of quantitative signal detection in EudraVigilance for orphan drugs: possible risk of false negatives.Therapeutic advances in drug safety · 2019Review
- Suspected Adverse Drug Reactions Related to Breast Cancer Chemotherapy: Disproportionality Analysis of the Brazilian Spontaneous Reporting System.Frontiers in pharmacology · 2019Article
- Safety Profile of Levonorgestrel: A Disproportionality Analysis of Food and Drug Administration Adverse Event Reporting System (Faers) Database.Journal of reproduction & infertilityArticle
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5 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of this study was to investigate whether database restriction can improve oncology drug pharmacovigilance signal detection performance.
methodsWe used spontaneous adverse event (AE) reports in the United States (US) Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Positive control (PC) drug medical concept (DMC) pairs were selected from safety information not included in the product's first label but subsequently added as label changes. These medical concepts (MCs) were mapped to the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) used in FAERS to code AEs. Negative controls (NC) were MCs with circumscribed PTs not included in the corresponding US package insert (USPI). We calculated shrinkage-adjusted observed-to-expected (O/E) reporting frequencies for the aforementioned drug-PT pairs. We also formulated an adjudication framework to calculate performance at the MC level. Performance metrics [sensitivity, specificity, positive and negative predictive value (PPV, NPV), signal/noise (S/N), F and Matthews correlation coefficient (MCC)] were calculated for each analysis and compared.
resultsThe PC reference set consisted of 11 drugs, 487 PTs, 27 MCs, 37 drug-MC combinations and 638 drug-event combinations (DECs). The NC reference set consisted of 11 drugs, 9 PTs, 5 MCs, 40 drug-MC combinations and 67 DECs. Most drug-event pairs were not highlighted by either analysis. A small percentage of signals of disproportionate reporting were lost, more noise than signal, with no gains. Specificity and PPV improved whereas sensitivity, NPV, F and MCC decreased, but all changes were small relative to the decrease in sensitivity. The overall S/N improved.
conclusionThis oncology drug restricted analysis improved the S/N ratio, removing proportionately more noise than signal, but with significant credible signal loss. Without broader experience and a calculus of costs and utilities of correct
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