ICH E3 places patient-level adverse-event listings in the report appendices and calls for listings that identify individual patients and relevant event details supporting review. A listing is not the same as a summary adverse-event table or a selected patient narrative; each serves a different level of safety reporting.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Adverse-event listings in a CSR provide patient-level event data that support the report’s summarized safety analyses and allow detailed regulatory review.
Key details
Core IssueICH E3 places patient-level adverse-event listings in the report appendices and calls for listings that identify individual patients and relevant event details supporting review.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
A listing is not the same as a summary adverse-event table or a selected patient narrative; each serves a different level of safety reporting.
Further guidance
Content
Provide the fields needed to identify the patient and characterize each event as required by the applicable report standard; keep listings readable and separate from narrative case summaries.
Purpose
Adverse-event listings in a CSR provide patient-level event data that support the report’s summarized safety analyses and allow detailed regulatory review.
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 section 12.3.3 calls for analysis and discussion across deaths, other serious adverse events, and other significant adverse events after the relevant case listings and narratives. This is an interpretive synthesis, not a duplicate death/serious-event listing or a replacement for individual patient narratives.
ICH E3 section 12.2.3 calls for analysis of adverse events beyond their tabular display, focusing on patterns important to safety interpretation. Do not treat the analysis as a substitute for the event display or patient-level listing, and do not imply causality beyond what the study evidence supports.
ICH E3 section 12.2.1 calls for a brief summary of adverse events within the safety evaluation before more detailed displays and analyses. Keep this section a high-level summary; it is not a substitute for detailed adverse-event displays, patient-level listings, serious-event treatment, or narratives.
ICH E3 section 12.2.2 provides for structured display of adverse events as part of the clinical study report safety evaluation. A summary display is distinct from patient-level adverse-event listings and from narratives of selected serious or otherwise significant cases.
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 section 12.3.1.3 distinguishes other significant adverse events from deaths and other serious adverse events for focused safety reporting. Do not merge this category with all adverse events, deaths, or other serious adverse events; ICH E3 gives these safety groupings separate reporting roles.
ICH E3 requires other serious adverse events to receive focused safety reporting, including patient-level listing and narrative treatment when needed to understand the event and its relationship to study treatment. ICH E3 distinguishes deaths from other serious adverse events for listing purposes; a fatal serious event may be referenced in both contexts, so counting and cross-references must remain clear.
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.
