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Logic Of How Serious Adverse Events are Distributed in 6.2 Summary Tabulations (Doc ID 3044853.1)

Last updated on SEPTEMBER 09, 2024

Applies to:

Oracle Life Sciences Argus Safety - Version 8.4 and later
Information in this document applies to any platform.

Goal

Please explain how Serious Adverse Events are distributed in different columns like Investigational Medicinal product, Active comparator, Blinded etc in the 6.2 Tabulation derived from ICH PSUR Report template.
 

Solution

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