Anti-Cancer Therapies Hierarchy

Hierarchy Check 

Introduction 

In Oncology studies, patients are often given a few different types of therapies before joining an experimental study. To examine the drug's effect, the study keeps track of these previous therapies in specific tables that describe additional anti-cancer treatments, both prior to the treatment or follow-up.

Purpose

Validates that the subgroup number of participants in every anti-cancer treatment is less than the overall number of participants with at least one anti-cancer treatment.

Applicability 

Inclusion conditions 

• Oncology studies only
• Only ADCM source data tables containing  the following phrases: 
  • “Prior anti cancer”
  • “Prior treatment”
  • “Prior therapy”
  • “Prior treatment prior therapy”

Exclusion 

• Non-oncology studies 
• All tables except ADCM 
• Empty tables
• Listing, Figure, ADaM, LoT

Discrepancies

• The number of participants in an anti-cancer treatment is greater than the number of overall participants with at least one anti-cancer treatment.

Discrepancy Example

• In the example shown here, the number of participants in the subgroup (“Subjects with at least one follow-up anti-cancer drug therapy”) is greater than the number of overall participants with at least one anti-cancer treatment (“Subjects with at least one type of follow-up anti-cancer therapy”).