Appendixes | Report Option Descriptions | Term Level

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:
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.
AETERM in AE
AEBODSYS in AE
AEHLT in AE
AEHLGT in AE
AESOC in AE
Uses Primary System Organ Class level of adverse events as categories.
AELLT in AE
Uses Lowest Level Term level of adverse events as categories.
AEBODSYS in AE
AEDECOD in AE
AETERM in AE
either CMTRT (for Concomitant Medications) or SUTRT (for Substance Use)
either CMDECOD (for Concomitant Medications) or SUDECOD (for Substance Use)

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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:
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