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.

High(er) Level Term (HLT)

AEHLT in AE

A superordinate descriptor for multiple preferred terms (PTs).

High(er) 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.

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

To Specify the Term Level:

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