Adverse Events Hierarchy

Hierarchy Check

Introduction

AE tables contain several groups and sub-groups. The number of participants in each subgroup must be less than or equal to the number of participants in a group.

Purpose

• Validates that:
  • The N value is greater than or equal to the number of participants with AE or specific AEs (serious AE, for example).
  • The number of participants in each System Organ Class is greater than or equal to the number of participants with Preferred terms under that System Organ Class.

Applicability 

Inclusion conditions 

• AE tables are identified by the keywords in the table title:
  • adverse events
  • AE
  • TEAE
  • SAE
  • TESAE
• SOC tables are identified by the keywords:
  • System Organ Class
  • SOC

Exclusion 

• Empty tables
• Non-numeric values 
• Listing, Figure, ADaM, LoT

Discrepancies

• SOC value is larger than N: The N value is less than the number of participants with AE or specific AEs (serious AE, for example).
• PT value is larger than SOC: The number of participants in each System Organ Class is less than the number of participants with Preferred terms under that system organ class.

Discrepancy Example

• The N value is less than the number of participants with AE or specific AEs