ICH E3 Section 10 requires accounting for patients who entered, were randomized, completed, or discontinued the study and for reasons for discontinuation, together with protocol-deviation information where applicable. This section is broader than a discontinued-patient listing: it explains the overall participant flow and disposition rather than serving only as a case-level appendix.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use the Study Patients section to show how participants moved through the study and to make disposition and important protocol deviations reviewable.
Key details
Core IssueICH E3 Section 10 requires accounting for patients who entered, were randomized, completed, or discontinued the study and for reasons for discontinuation, together with protocol-deviation information where applicable.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This section is broader than a discontinued-patient listing: it explains the overall participant flow and disposition rather than serving only as a case-level appendix.
Further guidance
Content
Present the patient disposition/accounting required by the protocol and report structure, explain discontinuations and relevant deviations, and cross-reference detailed listings when needed.
Purpose
Use the Study Patients section to show how participants moved through the study and to make disposition and important protocol deviations reviewable.
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 appendix 16.2.1 identifies a patient-level listing for discontinued patients as part of the clinical study report’s individual-patient data appendices. The exact categories and reasons should follow the study protocol and applicable submission conventions; this page does not impose one universal discontinuation taxonomy.
ICH E3 section 11.4.2.6 calls for efficacy analyses in relevant patient subsets to be presented or discussed when subgroup evidence is important to interpretation. Keep a defined efficacy subset distinct from the primary analysis population and from exploratory subgroup claims that require their own interpretation.
ICH E3 section 9.4.3 calls for the specific method used to assign patients to treatment groups, including relevant allocation, stratification, or blocking features. This report-body method section is distinct from the detailed randomization scheme and codes placed in appendix 16.1.7 and should not imply randomization when the study used another assignment method.
ICH E3 section 9.3.3 identifies Removal of Patients from Therapy or Assessment as a planned study-population subsection of the investigational plan. This subsection states planned removal criteria or procedures; it is not the same as the results-stage disposition of patients or a listing of patients who actually discontinued.
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.
