Number of Deaths Consistency

Consistency Between Tables Check

Introduction

Unfortunately in some studies, patients might not make it until the end of the study. This is very important to track, since this is the worst possible outcome, and it might have a great effect on the study endpoints or treatment approval

Purpose

Validates that the number of deceased patients is consistent across all different tables in the project. 

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:

• ‘Grade 5’ 
•  ‘death/s’ in the title or headers. 

Exclusion 

• Empty table

Discrepancies

• A mismatch in values between 2 or more applicable tables.

Discrepancy Example

There are different values in the number of death at the summary table to theTEAE causing by death table

Table1:

Table2: