In the NDA report under section Tabulation by SOC of All Events Reported should all Event Types be counted ?
(Doc ID 1354218.1)
Last updated on OCTOBER 24, 2011
Oracle Argus Safety - Version: 6.0 and later [Release: 6.0 and later ]
Information in this document applies to any platform.
In the NDA Periodic Report - Tabulation by SOC of All Events Reported - should symptoms that have been subsumed under a diagnosis appear and be counted?
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