Patients Excluded From Efficacy Analysis Listing
ICH E3 appendix 16.2.3 identifies a patient-level listing for patients excluded from the efficacy analysis. The listing supports the analysis-population explanation; it should not invent exclusions after the fact or replace the prespecified analysis-set definitions.
The excluded-patients listing makes efficacy-analysis exclusions transparent at patient level so reviewers can connect analysis-population decisions with individual subjects.
Key details
Important caveats
Scope Boundary
The listing supports the analysis-population explanation; it should not invent exclusions after the fact or replace the prespecified analysis-set definitions.
Further guidance
Content
Identify the affected subjects and the applicable exclusion basis clearly enough to reconcile the listing with the efficacy populations and analyses described in the report body.
Purpose
The excluded-patients listing makes efficacy-analysis exclusions transparent at patient level so reviewers can connect analysis-population decisions with individual subjects.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E3 Structure and Content of Clinical Study Reports (opens in a new tab)U.S. Food and Drug Administration · FDA-hosted ICH E3 guidance defining the structure and content of a core clinical study report