The Protect Adverse Drug and Product Reaction Database lists adverse drug reactions in 4.8 of the Summary of Product Characteristics (SPPC) of the EU authorized medicinal products based on centralized procedure. The database follows MedDRA terminology. MedDRA Preferred Terms (PT) are used to facilitate the accuracy of ADR descriptions.
MedDRA Preferred Terms (PT) are used to map terms of the SPC. When they are used in the SPC to add precision in the description of the ADR, Low Level Terms (LLTs) are also coded. PTs and LLTs are linked to a primary System Organ Class (SOC). The dataset also includes information on gender, causality, frequency, class warning and source of information for ADRs for which additional information is provided in the SPC.