Table 3.

Filters applied to the drug event paediatric age group list during initial manual assessment

Filter	Rationale
Serious eventa and new drug in the age groupb (≥2009)	To capture problems that were unlikely to be discovered in clinical trials or in national databases. A “new drug” reported for the age group can suggest that a new product has been approved for the age group or that a new clinical use of the drug is emerging in the age group and therefore needs monitoring.
Serious eventa and new drug in the age groupb (≥2005)
Serious eventa (no restriction to the newness of the drug)	Because this was the first screening of paediatric global data, the test included drug events that represented a wider scope, to allow previously unrecognised safety issues to emerge also for drugs, which had been on the market for a long time.
Negative disproportionality measure in the full VigiBase data setc and automatic exclusion of labelled adverse drug reactions based on the US Food and Drug Administration (FDA) product label24 and the European Summary of Product Characteristics (EU SmPC).25	To increase the chances of capturing signals specific to the paediatric age group but still being unknown and less likely to have been highlighted in previous signal detection screenings of the full VigiBase data set.

^aReports series referring to serious events using the ICH seriousness criteria,23 flagging pairs where all reports in the E2B format fulfilled one of the ICH seriousness criteria.23

^bNew drugs were defined as drugs first reported to VigiBase in the specific paediatric age group on/after 1st of January 2009 (≥ 2009) or on/after 1st of January 2005 (≥ 2005).

^cThe negative disproportionality measure referred here is based on the negative lower end point of the 95% credibility interval of the Information Component5, 6 (IC025 < 0) and denotes less reporting than expected in the full VigiBase data set.