Severe AE Consistency

Consistency Between Tables Check

Introduction 

AEs are assessed during clinical trials and are reported in multiple tables to regulatory authorities.In all clinical studies, adverse events are reported by their severity. There are 3 intensities for adverse events: Mild, Moderate, Severe. Severe AE are medically significant but not immediately life threatening. 

Purpose

Validates that the number of subjects with severe AEs is consistent across all different tables in the project.

Grade 3 is compared with Grade 3, while Severe is compared with Severe. 

In each study, the matching between files will be according to the details in the title:

• Population
• Treatment-related or All Causalities (can be both)
• Phase
• Subgroups
• Period (mainly vaccine)

Applicability 

Inclusion conditions 

Tables with the following keywords:

• Severity, severe, sev 
• Grade 3

Exclusion 

• Empty table

Discrepancies

A mismatch in values between 2 or more applicable tables.

Discrepancy Example