DSUR Fatal Line Listing

From the cases present in the main case series generated from the CTPR report configuration, the system prints only fatal cases (event seriousness=death) in the DSUR Fatal line listing. This line listing does not restrict cases based on reaction terms. That is, Print Serious Adverse Events or Reactions parameters are not used for Fatal line listing.

The following additional fields have been added to Fatal line listing over the Main line listing fields:

Table 6-4 Fatal Line Listing Fields

Field Name Description

Death Date and Cause of Death

Patient death date along with cause of patient death.

Verified

Y if the patient cause of death has been verified.

If CASE_DEATH_DETAILS.TERM_TYPE=2, cause of death came from autopsy results, which means cause of death verified=Y; otherwise N.