Individual Clinically Significant Abnormalities in Clinical Study Report
ICH E3 section 12.4.2.3 calls for discussion and analysis of individual clinically significant laboratory abnormalities, including assessment of clinical significance and likely treatment relationship. This is not a listing of every abnormal value: the focus is on clinically significant changes and their interpretation within the ICH E3 safety framework.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use this subsection to discuss clinically significant laboratory changes, including relevant serious or otherwise significant cases and the likely relationship of changes to treatment.
Key details
Core IssueICH E3 section 12.4.2.3 calls for discussion and analysis of individual clinically significant laboratory abnormalities, including assessment of clinical significance and likely treatment relationship.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is not a listing of every abnormal value: the focus is on clinically significant changes and their interpretation within the ICH E3 safety framework.
Further guidance
Content
Discuss clinically significant changes using the applicant’s defined criteria and assess features such as dose relationship, drug concentration, dechallenge/rechallenge, and concomitant therapy when relevant.
Purpose
Use this subsection to discuss clinically significant laboratory changes, including relevant serious or otherwise significant cases and the likely relationship of changes to treatment.
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 appendix 16.2.6 designates individual efficacy response data as a patient-level listing in the clinical study report supporting material. This is a patient-level listing function, not a substitute for aggregate efficacy tables, statistical analyses, or the broader individual-patient-data appendix overview.
ICH E3 appendix 16.2.8 addresses listings of individual laboratory measurements by patient when such listings are required by regulatory authorities. ICH E3 makes these patient-level listings conditional on regulatory requirements; this page does not imply that every CSR must include the same laboratory appendix.
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 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 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.
