Label the Algorithm
The system calculates listedness (the expectedness of the undesirable effect experienced in an AE) using an option that you choose when running the Periodic Benefit Risk Assessment Report (PBRER) or Development Safety Update Report (DSUR).
The following options are available:
- Use Assessment in cases from Event Assess table
- Use Assessment in cases from the Event Assess table for the configured License List
- Use Event Assess table with Report type + datasheets
- Re-assess cases against datasheet in effect at the beginning
- Re-assess cases against datasheet in effect at the end
This lets you specify which datasheet to look against for Listedness when running the report.
- When using the Event assessment from the case, the system considers only the As Determined listedness of the primary event or the case listedness.
- When you select the ALL datasheets Report Type, the system uses the most conservative listedness for the primary event, or the Case Listedness.
- When you select a specific datasheet, the system bases listedness on this datasheet.
- The datasheet for listedness on the Inclusion Criteria is calculated for ALL products within the case and not only for the first suspect drug.
For more information, see: