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 Level1	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.

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1

Multiple domains use this parameter. Input data determines the availability of 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:

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