Table 2.

Exclusion criteria for drug‐event pairs within the complete paediatric age group (reports with ages less than 18 y)

Exclusion Criteria for Drug‐Event Pairs With the Following:	Rationale
<3 or >30 reports	A restriction was made to drug‐event pairs to represent between three and 30 reports. The lower threshold was set to enable enough reports for assessment, and the limit to the maximum number of reports was set to increase the likelihood of capturing previously unknown problems (ie, signals) as well as rare adverse drug reactions, which holds the primary purpose of the international compilation of reports in VigiBase.
Single‐reported country	To complement national centres by focusing on global problems
No reports received in VigiBase after 1 January 2012	To be relevant and capture current problems