ICH E3 reserves section 14.3 for safety data displays, including adverse-event presentations and listings supporting deaths, serious events, laboratory findings, and other safety analyses. This page covers supporting ICH E3 safety displays and listings; it is distinct from the main Safety Results section and from patient narratives.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Safety tables in a CSR provide the detailed displays and listings that support the report body’s safety evaluation.
Key details
Core IssueICH E3 reserves section 14.3 for safety data displays, including adverse-event presentations and listings supporting deaths, serious events, laboratory findings, and other safety analyses.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This page covers supporting ICH E3 safety displays and listings; it is distinct from the main Safety Results section and from patient narratives.
Further guidance
Content
Organize section 14.3 displays so treatment groups, denominators, event categories, patient identifiers where appropriate, and links to the core safety discussion remain clear.
Purpose
Safety tables in a CSR provide the detailed displays and listings that support the report body’s safety evaluation.
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 9.5 calls for identification of the efficacy and safety variables assessed, the methods and timing of assessments, and the people or procedures responsible for measurements, often with a schedule or flow chart. This section defines variables and assessment methods; it is not the same artifact as the later efficacy or safety result tables.
ICH E3 reserves section 14.2 for efficacy tables, figures, and graphs referred to in the report but not included in the main text, allowing detailed displays to support the core efficacy analysis. This page is about supporting ICH E3 efficacy displays, not the broader Efficacy Results section that explains analyses and interprets findings in the report body.
ICH E3 section 12.6 calls for an overall safety evaluation that highlights important events, identifies patients or groups at increased risk, and discusses implications for possible use of the investigational product. This is an overall safety synthesis under ICH E3 12.6, not a duplicate event listing, safety table, or patient narrative.
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.
ICH E3 section 11.4.2.7 identifies special efficacy-analysis considerations for active-control studies intended to support equivalence. This is a CSR efficacy-results reporting issue for active-control equivalence designs; it does not define a universal equivalence margin or replace protocol-level design justification.
ICH E3 section 11.4.2.1 calls for covariate or prognostic-factor selection and adjustment to be explained, including adjustment methods, analysis results, supportive statistical documentation, and differences from planned analyses when relevant. This results-stage statistical issue is narrower than the general statistical-methods section and should not be used as a substitute for documenting the full analysis plan.
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.
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.
