Summary Tabulations of Serious Adverse Events
This section in the DSUR provides the main and cumulative summary tabulation of SAEs reported in the sponsor's clinical trials from the DIBD to the data lock point of the current DSUR. The report displays only serious events in this tabulation. You cannot display any non-serious events of special interest in this section as filtering is based on the seriousness of an event.
The tabulation is organized by Study and SOC for the investigational drug and for the comparator arm (active comparators, placebo, and treatment unknown due to blinding) used in the program.
The Development Safety Update Report provides the following tabulations:
- DSUR Main Summary Tabulation of Serious Adverse Events: This tabulation contains all serious cases from the main case series (interval period). For each case, the system prints a summary tabulation count SOC in the internationally agreed order, followed by PTs in rows.
- DSUR Fatal Cases Summary Tabulation: This tabulation is similar to the Main Summary tabulation, except that the report only prints cases where event seriousness criterion is death.
- DSUR Cumulative Summary Tabulation of Serious Adverse Events or DSUR
Cumulative Summary Tabulation of Serious Adverse Reactions: This
tabulation contains all serious cases from the cumulative case series. For each case
in the cumulative case series, the system prints summary tabulation counts broken
down by SOC in the internationally agreed order, followed by PTs in rows. This
tabulation prints either the serious adverse events or serious adverse reactions
based on the value of the report parameter Print Serious Adverse Events
or Reactions.
Based on the value of the above parameter, the heading of the cumulative tabulation indicates whether it is for a serious adverse reaction or a serious adverse event.
- DSUR Fatal Cases Cumulative Summary Tabulation of Serious Adverse Events
or DSUR Fatal Cases Cumulative Summary Tabulation of Serious Adverse
Reactions: This tabulation contains those serious cases from the
cumulative case series where the event seriousness criterion is death. For each
case, the system prints summary tabulation counts broken down by SOC in the
internationally agreed order, followed by PTs in rows.
This tabulation also uses the parameter Print Serious Adverse Events or Reactions.
- Print All Events: The summary tabulation displays all events present in the cases lying within the reporting period. The in period flag is not used. This is the default value.
- Print only In Period Events: This summary tabulation displays only events added within the reporting period. Events in the cases with Follow-up data that does not fall into the reporting period are not considered.
For more information, see: