Lionel Van Holle
Affiliation: GlaxoSmithKline Biologicals
- Optimization of a quantitative signal detection algorithm for spontaneous reports of adverse events post immunizationLionel Van Holle
Vaccine Safety Research Group, Vaccine Clinical Safety and Pharmacovigilance, GlaxoSmithKline Biologicals SA, Wavre, Belgium
Pharmacoepidemiol Drug Saf 22:477-87. 2013..To optimize the efficiency of signal detection by maximizing the proportion of true positive (TP) signals among signals detected by a disproportionality algorithm...
- Post-marketing monitoring of intussusception after rotavirus vaccination in JapanVincent Bauchau
Safety Department, GSK Vaccines, Wavre, Belgium
Pharmacoepidemiol Drug Saf 24:765-70. 2015..Some studies suggest that Rotarix(TM) may have a temporal association with a risk of intussusception (IS). We assessed a possible association between IS and Rotarix(TM) vaccination in Japan...
- Modelling Hospitalisation Ratios for Febrile Convulsions and Severe Varicella Under Combined Measles, Mumps, Rubella, and Varicella (MMRV-Priorix-Tetra™) Compared to Separate MMR + V VaccinationVincent Bauchau
GSK Vaccines, Avenue Fleming 20, 1300, Wavre, Belgium
Drug Saf 38:1095-102. 2015..However, the risk of developing febrile convulsions (FC) is higher in children vaccinated with MMRV...
- The upper bound to the Relative Reporting Ratio-a measure of the impact of the violation of hidden assumptions underlying some disproportionality methods used in signal detectionLionel Van Holle
Vaccine Safety Research Group, Vaccine Clinical Safety and Pharmacovigilance, GlaxoSmithKline Vaccines, Wavre, Belgium
Pharmacoepidemiol Drug Saf 23:787-94. 2014..Here, we provide the tools for allowing signal detection experts to assess the consequence of the violation of this assumption on their specific SRD...
- Signal detection based on time-to-onset: extending a new method from spontaneous reports to observational studiesLionel Van Holle
Vaccines Clinical Safety and Pharmacovigilance, GlaxoSmithKline Vaccines, Wavre, Belgium
Pharmacoepidemiol Drug Saf 23:849-58. 2014..The aim of this study was to assess the added value of this new TTO signal detection method adapted to observational studies...
- Use of logistic regression to combine two causality criteria for signal detection in vaccine spontaneous report dataLionel Van Holle
Vaccine Safety Research Group VSRG, Vaccines Clinical Safety and Pharmacovigilance VCSP, GlaxoSmithKline Vaccines, Parc de la Noire Epine, Avenue Fleming, 20, 1300, Wavre, Belgium
Drug Saf 37:1047-57. 2014....
- Using time-to-onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept studyLionel Van Holle
Safety and Observational Database Research, Epidemiology, GlaxoSmithKline Biologicals, Wavre, Belgium
Pharmacoepidemiol Drug Saf 21:603-10. 2012..In these analyses, time-to-onset (TTO; the time between vaccination and the onset of the adverse event) is rarely considered. Our objective is to assess the potential use of TTO to improve signal detection (SD)...
- 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 algorithmLionel Van Holle
Vaccine Safety Research Group VSRG, Vaccines Clinical Safety and Pharmacovigilance VCSP, GlaxoSmithKline Vaccines, Wavre, Belgium
Pharmacoepidemiol Drug Saf 23:178-85. 2014..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...