Signal detection on spontaneous reports of adverse events following immunisation: a comparison of the performance of a disproportionality-based algorithm and a time-to-onset-based algorithm.
Bottom Line: Time-to-onset (TTO) methods measure how unexpected the TTO distribution of a vaccine-event pair is compared with what is expected from other vaccines and events.Our purpose is to compare the performance associated with each method.The vaccine product labels were used as proxies for true safety signals.
Affiliation: Vaccine Safety Research Group (VSRG), Vaccines Clinical Safety & Pharmacovigilance (VCSP), GlaxoSmithKline Vaccines, Wavre, Belgium.Show MeSH
Mentions: Receiver operating characteristic plots 12 were generated for the three TTO algorithms (with time windows of 30, 60 and 90 days after immunisation) by varying the p-value threshold from 0 to 1 by 0.01 and for each MGPS set of stratification factors by varying the EB05 threshold from 0 to 10 by 0.1 (Figure 1). The ROC curves associated to TTO algorithms are above all MGPS ROC curves, whatever the choice of stratifications.
Affiliation: Vaccine Safety Research Group (VSRG), Vaccines Clinical Safety & Pharmacovigilance (VCSP), GlaxoSmithKline Vaccines, Wavre, Belgium.