products. Organization of the dictionary The MedDRA dictionary is organized with a five-level hierarchy. The highest or broadest level is System Organ Class (SOC), further divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT), and finally into the most granular Lowest Level Terms (LLT). In addition, the MedDRA dictionary includes Standardized MedDRA Queries (SMQs). SMQs are groupings of terms that relate to a defined medical condition or area of interest. SMQs are developed to facilitate retrieval of MedDRA-coded data as a first step in investigating drug safety issues in pharmacovigilance and clinical development. As of MedDRA 25.1, 110 SMQs have been created comprising 120 lower-level SMQs. Additional SMQs are created as the need arises. Individual cases are usually coded for data entry at the most specific (LLT) level, and outputs of counts or cases are usually provided at the PT level. The higher levels (HLT, HLGT, and SOC), as well as SMQs, are used for searching and for organizing and subtotalling outputs. MedDRA hierarchy The five-level hierarchy provides degrees or levels of super-ordination and subordination. The superordinate term is a broad grouping term applicable to each subordinate descriptor linked to it. Hierarchical levels thus represent vertical links in the terminology. Hierarchies are an important mechanism for flexible data retrieval and for the clear presentation of data. The five-level structure of this terminology provides options for retrieving data by specific or broad groupings, according to the level of specificity required. The Lowest Level Term (LLT) level provides maximum specificity. The terminology was not developed as a formal classification or taxonomy; each level in the hierarchy may reflect a variable degree of specificity or “granularity” from one System Organ Class to another. High-Level Terms (HLTs) and High-Level Group Terms (HLGTs) facilitate data retrieval and presentation by providing clinically relevant grouping of terms. Collectively, the HLT and HLGT levels are sometimes referred to as the “grouping terms” in MedDRA. The 27 System Organ Classes (SOCs) represent parallel axes that are not mutually exclusive. This characteristic, called “multi-axiality,” allows a term to be represented in more than one SOC and to be grouped by different classifications (e.g., by etiology or manifestation site), allowing retrieval and presentation via different data sets. Grouping terms are pre-defined in the terminology and not selected on an ad hoc basis by data entry staff. Rather, the terminology is structured so that selection of a data entry