Term and Group Level

Use this option to specify which levels of terms and groups to use as categories.

For Adverse Events

Possible term levels are listed in the following table:

Term Level1 Input data determines the availability of options. Not all term levels are available in all of the reports in which term levels are specified.	Corresponding Variable	Function
Reported Term for the Adverse Event	AETERM in AE	• Uses Reported Term for the Adverse Event level of adverse events as categories.
High Level Term (HLT)	AEHLT in AE	• A superordinate descriptor for multiple preferred terms (PTs).
Dictionary-Derived Term	AEDECOD in AE	• Uses Dictionary-Derived Term level of adverse events as categories.
High Level Group Term (HLGT)	AEHLGT in AE	• A superordinate descriptor for multiple higher level terms (HLTs)
Body System or Organ Class	AEBODSYS in AE	• Uses Body System or Organ Class level of adverse events as categories.

Possible group levels are listed in the following table:

Group Level2 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.	Corresponding Variable	Function
Reported Term for the Adverse Event	AETERM in AE	• Uses Reported Term for the Adverse Event level of adverse events as categories.
Dictionary-Derived Term	AEDECOD in AE	• Uses Dictionary-Derived Term level of adverse events as categories.
High Level Term (HLT)	AEHLT in AE	• A superordinate descriptor for multiple preferred terms (PTs).
High Level Group Term (HLGT)	AEHLGT in AE	• A superordinate descriptor for multiple higher level terms (HLTs)
Body System or Organ Class	AEBODSYS in AE	• Uses body system or Organ Class level of adverse events as categories.

For Events

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

Term Level3 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.	Corresponding Variable	Function
Reported Term for the Disposition Event	DSTERM in DS	• Uses Reported Term for the Disposition Event level.
Standardized Disposition Term	DSDECOD in DS	• Controlled terminology for the name of the disposition event or protocol milestone.
Category for the Disposition Event)	DSCAT	• Used to define a category of related events.

Possible group levels are listed in the following table:

Group Level	Corresponding Variable	Function
Reported Term for the Disposition Event	DSTERM in DS	• Uses Reported Term for the Disposition Event.
Standard Disposition Term	DSDECOD in DS	• Controlled terminology for the name of the disposition event or protocol milestone.
Category for Disposition Event	DSCAT	• Used to define a category of related events.

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.

Possible group levels are listed in the following table:

Group 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.
Standard 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.

To Specify the Term and Group Level:

8

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