ReSD Form 9 (Unlisted Events Table)

• The data is fetched directly from the case data.
• Data inclusion logic is same as that of the existing PSR NUPR Form 7.
• Includes Japan cases only.
• The data is fetched from the start of first time frame to the end of last time frame.
• Includes both ADR and Infections.
• Populates both Serious and Non-Serious Reactions which are segregated in the table layout in the form.
• Contains Related and Unlisted Events only (Listedness is determined based on both Case Assessment and Datasheet).
• Report output includes separate columns for Case Count and Event Count.
• Categorizes or groups preferred terms under SOC's.
• Generates the Case Listing report with an indication for events assessed as Unknown or blank.
• The report output supports advanced conditions and generation on DLP.