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.

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.