Supplementary Analysis
https://w3id.org/m11-rdf/C217351.C218481
- Definition
- A description of the analyses that are conducted in addition to the main and sensitivity analysis with the intent to provide additional insights into the understanding of the treatment effect.
- Namespace
- ICH M11 Section 10 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.10+C218481(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218481 (EVS identifier)
NCIT_C218481 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217351.C218481 (EVS term IRI; does not resolve)
- Label from
- ICH M11 Terminology, NCI EVS, release 2025-12-19
Specifications in the Technical Specification
One row per component block of Appendix 1 that names this element. Text as printed.
| Block | Term | Section | Conformance | Cardinality | Data type | Value code list | Repeating / reuse |
|---|---|---|---|---|---|---|---|
| 477 | {<Supplementary Analysis>} | 10.4 Analyses Associated with the Primary Objective(s) 10.4.X.5 | Conditional: when there is Supplementary Analysis for a Primary Objective | One to one | Text (D) | Yes, repeatable for each objective as a series of level 4 sections (10.4.X.1, 10.4.X.2, 10.4.X.3, 10.4.X.4, 10.4.X.5). | |
| 489 | {<Supplementary Analysis>} | 10.5 Analyses Associated with the Secondary Objective(s) 10.5.X.5 | Conditional: when there is Supplementary Analysis for a Secondary Objective | One to one | Text (D) | Yes, repeatable for each objective as a series of level 4 sections (10.5.X.1, 10.5.X.2, 10.5.X.3, 10.5.X.4, 10.5.X.5). |
In the ICH M11 Template
The Template heading of 10.4.1.5 Supplementary Analysis, 10.5.1.5 Supplementary Analysis is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 10.4.1.5 Supplementary Analysis 10.4.1.5 | <Enter Supplementary Analysis> | conditional | p. 56 | ts-term / verb-dropped / section |
| 10.5.1.5 Supplementary Analysis 10.5.1.5 | <Enter Supplementary Analysis> | conditional | p. 57 | ts-term / verb-dropped / section |
Mapping statements to USDM v4
None: no row of the two pinned mappings is identified with this element and resolves in USDM v4.0.0.
Draft, not normative. A derived rendering of the ICH M11 Technical Specification, Template, code lists and OID Listing (© ICH, used under the ICH Legal Mentions) and of the ICH M11 Terminology published by NCI EVS (CC BY 4.0). Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH.