Report Parameters to Print Reactions or Serious Events

The Print Serious Adverse Events or Reactions parameter prints serious adverse events (SAE) or serious adverse reactions (SAR) based on the parameter value. This parameter can have the following possible values:

• Print Serious Adverse Reactions (default)

• Print Serious Adverse Events

Based on the value of this parameter, headings of various line listings or tabulations indicate whether they are for SAEs or SARs. The system displays the following titles for main line listing depending on the parameter values:

Table 6-3 Main Line Listing Titles

Parameter Value	Main Line Listing Title
Print Serious Adverse Reactions	DSUR Main Line Listing for Serious Adverse Reactions
Print Serious Adverse Events	DSUR Main Line Listing for Serious Adverse Events

The system uses the most conservative causality approach for identifying reactions. Most conservative causality means that either reported or company causality is defined for a combination of product and event.