Discontinued Patients Listing in Clinical Study Report
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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
The Discontinued Patients Listing provides subject-level detail supporting the report’s accounting of withdrawals, treatment discontinuations, or study discontinuations.
Key details
Core IssueICH 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.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
The exact categories and reasons should follow the study protocol and applicable submission conventions; this page does not impose one universal discontinuation taxonomy.
Further guidance
Content
Present the relevant subject identifiers and discontinuation information so the listing can be reconciled with disposition summaries in the report body.
Purpose
The Discontinued Patients Listing provides subject-level detail supporting the report’s accounting of withdrawals, treatment discontinuations, or study discontinuations.
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 12.4.1 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 11.4.2.6 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 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 appendix 16.1.6 calls for a listing of subjects who received specific investigational-product test-drug batches when more than one batch was used. This appendix is conditional on the use of more than one relevant batch and is distinct from broader investigational-product accountability, dose, and exposure narratives.
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 appendix 16.2.2 identifies a patient-level protocol-deviations listing, while the E3 Q&A clarifies the meaning of protocol deviation and important protocol deviation. This appendix-level listing is distinct from a general protocol-deviations narrative section, and classification should follow the study’s applicable definitions rather than an invented universal threshold.
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.
