AE/Events/Interventions Distributions Workflows and Computations

The AE Distribution report is used as an example to describe the analysis performed. This report has the most sophisticated dialog options of all the distribution reports for customizing the resulting reports. Other Events/Interventions domains follow a similar, although simpler, workflow .

AE Distribution requires (or expects) several demographic- and specific domain-related variables to generate full report results. The system is flexible. If a certain variable does not exist, the analysis is still performed without it whenever a related variable can be substituted. For example, in adverse event , required, or expected, variables include:

•

USUBJID ,

•	a treatment variable (examples include either TRTxxP or TRTxxA , ARM , or a specified comparison variable 1 ),

•	AGE , SEX , RACE , SITEID , COUNTRY , STUDYID (All are optional),

•	Treatment Date/Time variables (required if filtering interventions/events based on study treatment). These can include TRTSDTM , TRTSDTC , TRTEDTM , TRTEDTC ( ADSL ) or RFXSTDC , RFSTDTC , RFXENDTC , RFENDTC (DM domain), EXSTDTC , and EXENDTC (EX domain),

•	AEDECOD , AETERM , AEBODSYS , or other higher level term (at least one of these is required),

•	AESTDTC (Required),

•	AESER , either AESEV or AETOXGR , AEREL , AEOUT , and AEACN (All are optional).

The AE Distribution dialog (shown below) enables you to use the term level and group level that are available in your ae.sas7bdat data so that while AEDECOD and AEBODSYS are specified by default variables in the examples shown here, this specification can be customized based on the term levels available in the given Study.

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1

NONE can also be specified here.