Term and Group Level

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

For Adverse Events

Possible term and group levels are listed in the following table:

Term and Group Level

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.

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: 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.

For Events

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

Term and Group Level

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.

Note: 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.

For Interventions

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

Term and 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.

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.

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.