An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance.
Luis Correia PinheiroGianmario CandoreCosimo ZaccariaJim SlatteryPeter ArlettPublished in: Pharmacoepidemiology and drug safety (2017)
The results are encouraging and suggest that the algorithm could be useful for the detection of concerns that manifest as changes in frequency of reporting; however, further testing, including in prospective use, is warranted.