Group Level

Use this option to specify the level for grouping preferred terms or verbatim terms.

Possible group levels are listed in the following table:

Group Level	Corresponding Variable	Function
Body System	AEBODSYS in AE	• Uses a dictionary-derived text description of the affected body system, listed in the AEBODSYS column in AE.
Higher Level Term (HLT)	AEHLT in AE	• A superordinate descriptor for multiple preferred terms (PTs).
Higher Level Group Term (HLGT)	AEHLGT in AE	• A superordinate descriptor for multiple higher level terms (HLTs)
Standard MedDRA Query		• Grouping of MedDRA terms, at a defined level, that describes a specific medical condition.
Primary System Organ Class (SOC)	AESOC in AE	• Uses Primary System Organ Class level of adverse events as categories.
Lowest Level Term (LLT)	AELLT in AE	• Uses Lowest Level Term level of adverse events as categories.
Body System or Organ Class	AEBODSYS in AE	• Uses body system or Organ Class level of adverse events as categories.
Dictionary-Derived Term	AEDECOD in AE	• Uses Dictionary-Derived Term level of adverse events as categories.
Reported Term for the Adverse Event	AETERM in AE	• Uses Reported Term for the Adverse Event level of adverse events as categories.
Category	CMCAT in CM, or SUCAT in SU	• Uses Category level of interventions as categories.
Category for Medication	CMCAT in CM, or SUCAT in SU	• Uses Category level of interventions as categories.

Multiple domains use this parameter. Input data determines the availability of Group Level options. Not all group levels are available in all of the reports in which term levels are specified.

Note: The dictionary name and version used to generate the descriptions should be included as part of the submission.

Note: In some reports, options are dynamically populated by available terms (with the list available filtered based only on hierarchically sensible grouping choices).

To Specify the Group Level:

8

Select the group level corresponding to the adverse event or intervention terms that you want to use from the drop-down menu.