1. User's Guide
  2. Reports
  3. Reports: PMDA Periodic Reports
  4. Seiyakukyo Line Listing Report (Individual Report Common Line List)
  5. Report Output Filter Criterion

Report Output Filter Criterion

  • Regular (Clinical) and Domestic Study Cases - All the data is fetched based on the events reported in the Expedited/E2B reports already reported to PMDA.
    • Only the Expedited/E2B reports sent to the reporting destinations which are configured as the Seiyakukyo Configuration > Subject of Report tab > Primary Agency are considered.
    • Only the Expedited/E2B reports whose cases have at least one of their Case Classifications configured as Seiyakukyo Configuration > Study Selection tab > Selected Classifications for Regular and Domestic Study Cases are considered.
    • Only the Expedited/E2B reports that have J.11 (mhlwcompoundnum) element value same as one of the values configured as Seiyakukyo Configuration > Study Selection tab > Selected Clinical Compound Numbers are considered.
    • Only the Expedited/E2B reports that have J.4a (mhlwadmicsrcasenumclass) element value as 8, 9, 10, and 11 (reporting categories - H, I, J, and K) are considered.
    • All Nullification and Downgrade reports are ignored. However, their Initial and Follow-up reports that fall within the Seiyakukyo current timeframe are still considered.
    • If multiple Initial or Follow-up Expedited/E2B reports for any product license (any series of Expedited/E2B reports) fall within the current timeframe, all of them are considered.
    • Only the Expedited/E2B reports that have Report Submission Date (GMT) between and including the Start and End date (after conversion to GMT based on database time zone offset) configured for the current timeframe of the Seiyakukyo report are considered.
    • If the radio option to include Unlisted events only is configures, it includes only those reported events from the Expedited/E2B reports that are unlisted in the case.

      Unlisted - Specified as Unlisted in the case against at least one Japanese Investigational license (License Drug Authorization Country as Japan) having same clinical compound number as configured in Seiyakukyo report. The Listedness specified as Unknown is not considered.

    • If the radio option to include Listed and Unlisted events is configures, it includes all the reported events (listed and unlisted both).
    • If the check box to exclude incompletion reports is checked on the Individual Report Common Line List configuration tab, any Expedited/E2B report that have J.6 (Mhlwadmicsrcompleteclass) element value as 1 (Incomplete) is ignored.
    • If the check box to exclude Paper reports is checked on Individual Report Common Line List Configuration tab, all PMDA Paper Expedited reports are ignored.
    • If the same AE/Infection event is reported in multiple eligible reports from the same case, all of them are reported multiple times in the Seiyakukyo report as well.
    • All the events in Seiyakukyo report for Regular (Clinical) and Domestic Study Cases are sorted in the following order:
      • Case ID Number (ascending)
      • Report Submission Date (Old to New)
      • Events as ordered in the expedited/E2B report
  • Foreign Ichihen Study Cases - All the data is fetched based on the events present in the case data.
    • Only the cases that have Country of Incidence other than Japan are considered.
    • Only the cases that have at least one of their Case Classifications configured as Seiyakukyo Configuration > Study Selection tab > Selected Classifications for Foreign Ichihen Study Cases are considered.
    • Only the cases that have at least one of their Japan Information Receipt Date (significant follow-up or initial receipt date) between and including the Start and End date configured for the current timeframe of the Seiyakukyo report are considered.
    • Only the cases that have one of their Japanese licenses as present in the Case Form > Event Assessment tab and have the same Clinical Compound Number configured as Seiyakukyo configuration > Study Selection tab > Selected Clinical Compound Numbers are considered.
    • Only those events from the cases that have the Seiyakukyo products specified as:

      Related - At least one of the As Reported and As Determined Causality in the case is specified as Reportable for this Product Event combination.

      Unlisted - Specified as Unlisted in the case against at least one Japanese Marketed or Investigational license (License Drug Authorization Country as Japan) having same clinical compound number as configured in Seiyakukyo report. The Listedness specified as Unknown is not considered.

      Serious - The event is specified as Serious.

    • All the events in the Seiyakukyo report for Foreign Ichihen Study Cases are sorted in the following order:
      • Case ID Number (ascending)
      • Japan Information Receipt Date (significant follow-up or Initial Receipt Date) (Old to New)
      • Events as ordered in the case
  • If the check box to include foreign AE marked as Not include for the report in Japan is checked on the Individual Report Common Line List Configuration tab, those events are also included. Else, such events are ignored from the cases.

Parent topic: Seiyakukyo Line Listing Report (Individual Report Common Line List)