Drug and event hierarchies

A hierarchy determines how adverse event terms and drug terms are organized in the source data. For example, the FOI FDA Adverse Event Reporting System (AERS) database uses the Medical Dictionary for Regulatory Activities (MedDRA) classification system. Other databases might use the Coding Symbols for a Thesaurus of Adverse Events (COSTART) or the WHO Anatomical Therapeutic Chemical (ATC) classification systems.

Hierarchy terms are stored in an Oracle database account called the hierarchy account. You associate each variable in a data configuration with a hierarchy level in the hierarchy account. For example, if the source data contains MedDRA terms, you associate each variable in the data configuration with a MedDRA hierarchy level such as PT, HLT, HLGT, or SOC in the hierarchy account.

If a data configuration supports timestamped data, you must specify a hierarchy version for each time period in the source data. A time period is a range of dates during which only one hierarchy version was used.

When you set up hierarchy information, users can:

• Select the Enable Drug Hierarchy Browser user preference.
• Select the Include drug/event hierarchies' primary paths in run results option in the Data Mining Parameters page.
• Display a sector map for data mining results.

Note:

You can also set up hierarchy information using hierarchy tables. Hierarchy tables are supported for backward compatibility.