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Table 2 Insulin aspart: matching adverse events on PT, HLT, and HLT or SMQ level

From: Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase®

LevelEVDASFAERSVigiBase®Medical concept
PTKetoacidosisKetoacidosisKetoacidosisKetoacidosis (PT)
HLTDiabetic comaComaComaComa states (HLT)
HLT or SMQRetinal haemorrhageRetinal haemorrhageVitreous haemorrhageRetinal disorders (SMQ)
  1. EVDAS EudraVigilance Data Analysis System, FAERS FDA Adverse Event Reporting System, FDA Food and Drug Administration, HLT High Level Term, PT Preferred Term in MedDRA®, SMQ Standardized MedDRA® Query