Discontinuation Due to AE Consistency

Consistency Between Tables Check

Introduction

In the realm of clinical trials, it's imperative to meticulously track participants' progress. Premature discontinuation, particularly due to adverse events (AEs), necessitates thorough validation to ensure data integrity. It is crucial verifying that the number of subjects discontinuing due to AEs remains consistently reported. 

Purpose

Validates that the number of subjects discontinued from the study due to adverse events is consistent across all different tables in the project

Applicability 

Inclusion conditions 

• Summary of TEAEs tables
  • Tables that contain with the keywords withdrawn or discontinued, such as:
  • Discontinued from study
  • Discontinued from study drug
  • Overall summary of treatment emergent AE
  • Disposition tables
• The following characteristics are being validated:
  • Population
  • Treatment-related or All Causalities (can be both)
  • Phase
  • Subgroups
  • Period (mainly vaccine)

Exclusion 

• Empty table

Discrepancies

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

Discrepancy Example

The number or participant discontinued due to TEAEs differs, for the same cohort.