Any AE Consistency

Consistency Between Tables Check

Introduction 

An adverse event (AE) is any untoward medical occurrence in a patient or participant in a clinical trial, which does not necessarily have a causal relationship with the treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

Purpose

Validates that: 

• The total number of AEs are consistent across all tables in the project.
• The total number of subjects/participants with AEs are consistent across all tables in the project.
• The following characteristics are validated:
  • Population
  • Treatment-related and/or All Causalities 
  • Phase
  • Subgroups
  • Period (mainly vaccine)

Applicability 

Inclusion conditions 

• Tables with the following keywords:

• Number of AEs: 
  • Number of adverse events 
  • Number of TEAEs 
  • Total preferred term events 
  • Total No. of AEs by preferred term
• Participants with AEs: 
  • Subjects with adverse events
  • Participants with adverse events
  • With any adverse event 
  • Subjects with TEAEs

Exclusion 

• Empty table

Discrepancies

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

Discrepancy Example

The total number of TEAE in the two tables differs for the same group: