ICH E3 section 11.4.6 identifies by-patient displays as a distinct part of efficacy evaluation for showing individual response information when useful. A by-patient efficacy display is not the same as the appendix listing of adverse events or a narrative case report; keep efficacy and safety purposes distinct.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
By-patient displays let reviewers inspect individual efficacy patterns behind aggregate summaries without replacing the primary statistical analysis.
Key details
Core IssueICH E3 section 11.4.6 identifies by-patient displays as a distinct part of efficacy evaluation for showing individual response information when useful.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
A by-patient efficacy display is not the same as the appendix listing of adverse events or a narrative case report; keep efficacy and safety purposes distinct.
Further guidance
Content
Use a patient-level display structure that makes treatment, relevant baseline information, and response values traceable enough for the intended review.
Purpose
By-patient displays let reviewers inspect individual efficacy patterns behind aggregate summaries without replacing the primary statistical analysis.
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.
ICH E3 emphasizes that analyses, tables, and figures should clearly identify the set of patients from which the displayed result was generated. This is a results-display identification rule, not a substitute for prospectively defining analysis populations in a protocol or statistical analysis plan.
ICH E3 states that estimated or derived values used in a table, figure, or data listing should be conspicuously identified and their derivation and underlying assumptions explained. This display rule is broader than the patient-level listing guide: it applies across tables, figures, and data listings wherever estimated or derived values appear.
ICH E3 section 12.4.2.2 calls for analysis of individual patient laboratory changes by treatment group and gives several possible display approaches. This subsection focuses on within-patient change; it is distinct from group-level values-over-time summaries and from the raw measurement listing.
ICH E3 uses appendices for individual-patient data listings that support critical analyses, including specified listings for disposition, deviations, demographics, efficacy, adverse events, and laboratory measurements. The exact listings and submission format can depend on the reviewing authority; this page is about the ICH E3 report function, not a universal requirement to publish raw patient data publicly.
ICH E3 calls for narrative descriptions for deaths, other serious adverse events, and selected other significant adverse events when needed to understand the clinical course and relationship to study treatment. Narratives are not required for every participant or every event. Follow the applicable CSR/regulatory criteria for which cases warrant narrative treatment and protect personal information appropriately.
ICH E3 section 9.4.5 addresses rules or methods used to select the dose and timing of dose for individual patients. This is the patient-level dosing procedure subsection, not the preceding rationale for selecting the study doses or the later results analysis of dose-response relationships.
ICH E3 distinguishes specified patient listings in Appendix 16.2 from all individual-patient archival listings requested only in the United States under Appendix 16.4. The Appendix 16.4 archival-listing statement is explicitly U.S.-specific in ICH E3 and should not be generalized to every ICH region.
ICH E3 section 12.4.1 points to a by-patient listing of abnormal laboratory values in section 14.3.4 and distinguishes that safety display from the broader listing of individual laboratory measurements. This page is about the dedicated abnormal-value listing under ICH E3 14.3.4; it is distinct from the full individual-measurement appendix under 16.2.8 and from analytical discussion in section 12.4.2.
