ArticleDrug safety2010
Modelling the time to onset of adverse reactions with parametric survival distributions: a potential approach to signal detection and evaluation.
Article in Drug safety, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 16 citations in OpenAlex.
- Adverse event profile of fondaparinux sodium: a disproportionality analysis based on FAERS, JADER, and VigiAccess databases.Frontiers in medicine · 2026Article
- Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination.Drug safety · 2024Article
- Tumor lysis syndrome signal with the combination of encorafenib and binimetinib for malignant melanoma: a pharmacovigilance study using data from the FAERS database.Frontiers in pharmacology · 2024Article
- A real-world pharmacovigilance analysis of adverse events associated with irbesartan using the FAERS and JADER databases.Frontiers in pharmacology · 2024Article
- Time to onset in statistical signal detection revisited: A follow-up study in long-term onset adverse drug reactions.Pharmacoepidemiology and drug safety · 2019Article
- Estimating time-to-onset of adverse drug reactions from spontaneous reporting databases.BMC medical research methodology · 2014Article
- The impact of duration of treatment on reported time-to-onset in spontaneous reporting systems for pharmacovigilance.PloS one · 2013Article
- A signal detection method to detect adverse drug reactions using a parametric time-to-event model in simulated cohort data.Drug safety · 2012Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIt has been postulated that the time to onset of adverse drug reactions is connected to the underlying pharmacological (or toxic) mechanism of adverse drug reactions whether the reaction is time dependent or not.
objectiveWe have conducted a preliminary study using the parametric modelling of the time to onset of adverse reactions as an approach to signal detection on spontaneous reporting system databases.
methodsWe performed a parametric modelling of the reported time to onset of adverse drug reactions for which the underlying toxic mechanism is characterized. For the purpose of our study, we have used the reported liver injuries associated with bosentan, and the infections associated with the use of the tumour necrosis factor (TNF) inhibitors, adalimumab, etanercept and infliximab, which are used in Crohn's disease and rheumatoid arthritis, reported to EudraVigilance between December 2001 and September 2006.
resultsThe main results reflect the fact that the reported time to onset is a surrogate of the true time to onset of the reaction and combines three hazards (occurrence, diagnosis and reporting) that cannot be disentangled. Consequently, the modelling of the time to onset of reactions reported with TNF inhibitors showed differences that could reflect different pharmacological activities, indications, monitoring of the patients or different reporting patterns. These variations could also limit the interpretation of the parametric modelling.
conclusionsSome consistency that was found between the occurrences of the infections with the TNF inhibitors suggests a causal association. There are statistical issues that are important to keep in mind when interpreting the results (the impact of the data quality on the fit of the distributions and the absence of a test of hypothesis linked to the absence of a relevant comparator). The study suggests that the modelling of the reported time to onset of adverse reactions could be a useful adjunct to other signal detection methods.
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