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 Level

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: 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.

For Interventions

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

Term Level

Corresponding Variable

Function

Reported Term for the Drug, Med, or Therapy

CMTRT in CM
• Verbatim medication name that is either preprinted or collected on a CRF.

Standardized Medication Name

CMDECOD in CM
• Standardized or dictionary-derived text description of CMTRT. Equivalent to the generic drug name in WHO Drug.
Category for Medication

CMCAT in CM
• Used to define a category of medications/treatments.