Demoted Preferred Term Does Not Display in the PMDA Periodic Reports
Last updated on JULY 15, 2013
Applies to:Oracle Argus Safety Japan - Version 7.0.1 to 7.0.2 [Release 7.0.0]
Information in this document applies to any platform.
If the Preferred Term was demoted in the latest MedDRA version, this Preferred Term does not display in the following PMDA periodic reports
- ReSD > Tabulation for Unlisted Events Report (再審査報告 > 一覧： 未知の有害事象の一覧)
- ReSD > Tabulation for Listed Events Report (再審査報告 > 一覧： 既知の有害事象の一覧)
- Seiyakukyo Line Listing Report (個別報告共通ラインリスト - 未知・重篤副作用等の症例一覧)
Currently, the latest MedDRA version is 16.0. The term "Accidental exposure"(偶発的曝露) was demoted from the MedDRA v16.0.
In a case event, the term "Accidental exposure"(偶発的曝露) has already been coded in MedDRA Version 15.0.
When you print the above PMDA periodic report, the PT "偶発的曝露" will not display, or be counted, for this case because this Preferred Term was demoted in the latest version.
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