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ReSD Listed/Unlisted Events Tabulation Prints 'Count Of Time To Onset For Events' in an Inappropriate Column (Doc ID 2755419.1)

Last updated on MARCH 01, 2021

Applies to:

Oracle Argus Safety Japan - Version 8.2.2 and later
Information in this document applies to any platform.


On PMDA ReSD at Tabulation for Listed/Unlisted Events section, the number of Count of Time to Onset for Events is printed at "Unknown" column instead of printed at appropriate matching Weeks or Years column.

Steps to Repeat:

  1. Create a new case and enter data for the case.
  2. Set Dosage Start Date and Dosage End Date for the case product, and set Event Onset Date for the event. Confirm that Onset Latency field is automatically filled by days value.
  3. Schedule ICSR for PMDA, generate it and submit it.
  4. Create a new ReSD and configure it so that the above case event is included. Agency --- The agency the above case ICSR was submitted. "Print all configuration criteria on separate cover page" check-box --- Checked. "ReSD Form-11" check-box --- Checked. "Unlisted Events Tabulation" check-box --- Checked. Schedule --- Set time frame period includes the submitted date of the above case ICSR.
  5. Print the ReSD as Draft.
  6. Save the generated ReSD output into an MS Word file.
  7. Check the generated ReSD output. ---> At Form-11, the Event of the case appears. This is fine. At the "Tabulation for Unlisted Events" section, the Event of the case appears in the table. However, the number for Count of Time to Onset for Events is not printed at appropriate matching Weeks or Years column but printed at "Unknown" column.


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