Term Level

Use this option to specify which level of terms (for example, adverse event, intervention, or MedDRA) to use as categories.

Possible term levels are report-specific and are listed in the following table:

Term Level1	Corresponding Variable	Function
Preferred Term (PT)	AEDECOD in AE	• Uses a dictionary-derived text description of the adverse event, listed in the AEDECOD column in AE, that defines the corresponding value in the AETERM or AEMODIFY column. • A preferred term is restricted to a single medical concept.
Verbatim Term (VT)	AETERM in AE	• Select this option to use the term as listed in the adverse event term variable. • Verbatim terms are identified by values within the reported term (AETERM) variable of AE.sas7bdat data set.
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.
Reported Name	either CMTRT (for Concomitant Medications) or SUTRT (for Substance Use)	• Uses Reported Name level of intervention as categories.
Standardized Name	either CMDECOD (for Concomitant Medications) or SUDECOD (for Substance Use)	• Uses Standardized Name level of intervention as categories.

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1

Input data determines the availability of options. Not all term 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.

To Specify the Term Level:

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