ArticlePharmacoepidemiology and drug safety2019
Time to onset in statistical signal detection revisited: A follow-up study in long-term onset adverse drug reactions.
Article in Pharmacoepidemiology and drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Association of potentially inappropriate medications with rehospitalisation and death within three months in older patients: a systematic review and meta-analysis.International journal of clinical pharmacy · 2026Pooled it
- Pharmacovigilance and network toxicology analysis of risdiplam-associated adverse events in pediatric patients with spinal muscular atrophy.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Theoretical Framework and Key Considerations for Time-to-Onset Analysis in Spontaneous Reporting Systems.Drug safety · 2026Review
- Article
- Safety profile of lanreotide: a retrospective post-marketing pharmacovigilance study based on the real-world data from FAERS database.Endocrine · 2025Article
- Natural language processing for automated triage and prioritization of individual case safety reports for case-by-case assessment.Frontiers in drug safety and regulation · 2023Article
- Time to onset in statistical signal detection revisited: A follow-up study in long-term onset adverse drug reactions.Pharmacoepidemiology and drug safety · 2019Article
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4 authors.
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No grant is acknowledged in the PubMed record.
Abstract
purposeIn a previous study, we developed a signal detection method using the time to onset (TTO) of adverse drug reactions (ADRs). The aim of the current study was to investigate this method in a subset of ADRs with a longer TTO and to compare its performance with disproportionality analysis.
methodsUsing The Netherlands's spontaneous reporting database, TTO distributions for drug-ADR associations with a median TTO of 7 days or more were compared with other drugs with the same ADR using the two-sample Anderson-Darling (AD) test. Presence in the Summary of Product Characteristics (SPC) was used as the gold standard for identification of a true ADR. Twelve combinations with different values for the number of reports and median TTO were tested. Performance in terms of sensitivity and positive predictive value (PPV) was compared with disproportionality analysis. A sensitivity analysis was performed to compare the results with those from the previous study.
resultsA total of 38 017 case reports, containing 32 478 unique drug-ADR associations. Sensitivity was lower for the TTO method (range 0.08-0.34) compared with disproportionality analysis (range 0.60-0.87), whereas PPV was similar for both methods (range 0.93-1.0). The results from the sensitivity analysis were similar to the original analysis.
conclusionsBecause of its low sensitivity, the developed TTO method cannot replace disproportionality analysis as a signal detection tool. It may be useful in combination with other methods.
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