Treatment
https://w3id.org/m11-rdf/C217344.C49236
- Definition
- The treatment condition of interest and, as appropriate, the alternative treatment condition to which comparison will be made (referred to as "treatment" through the remainder of this document). These might be individual interventions, combinations of interventions administered concurrently, e.g. as add-on to standard of care, or might consist of an overall regimen involving a complex sequence of interventions.
- Namespace
- ICH M11 Section 3 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.3+C49236(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C49236 (EVS identifier)
NCIT_C49236 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217344.C49236 (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 |
|---|---|---|---|---|---|---|---|
| 182 | {<Treatment>} | 3.1 Primary Objective(s) and Associated Estimand(s) 3.1.X where X is a unique number for each Primary Objective | Conditional: If there is a treatment as estimand characteristic | One to Row Heading; One to Primary Objective Table; Project Identifier | Text (D) | Yes, repeatable for each numbered Primary Objective | |
| 200 | {<Treatment>} | 3.2 Secondary Objective(s) and Associated Estimand(s) 3.2.X where X is a unique number for each Secondary Objective | Conditional: If there is a population for Secondary | One to Row Heading, One to Secondary Objective Table, Project Identifier | Text (D) | Yes, repeatable for each numbered Secondary Objective. | |
| 218 | {<Treatment>} | 3.3 Exploratory Objective(s) 3.3.X where X is a unique number for each Exploratory Objective | Conditional: If there is a treatment as estimand | One to Row Heading; One to Exploratory Objective Table; Project Identifier | Text (D) | Yes, repeatable for each numbered Exploratory Objective. |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 3.1.1 Primary Objective 3.1.1 | <Enter Treatment> | conditional | p. 28 | ts-term / verb-dropped / section |
Mapping statements to USDM v4
One row per published mapping row that names this element (SSSOM record). The link to the USDM attribute is the mapping publisher's; how the row was tied to this element is in the third column. Paths as given.
| Source | USDM attribute (usdm-rdf) | Identified | Target path | Condition |
|---|---|---|---|---|
| HL7 CSP IG ballot row 120 | StudyIntervention-label stated: StudyIntervention.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| HL7 CSP IG ballot row 121 | AdministrableProduct-label stated: AdministrableProduct.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| HL7 CSP IG ballot row 123 | Administration-frequency stated: Administration.frequency (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| HL7 CSP IG ballot row 124 | Administration-route stated: Administration.route (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| HL7 CSP IG ballot row 125 | StudyIntervention-label stated: StudyIntervention.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| HL7 CSP IG ballot row 126 | AdministrableProduct-label stated: AdministrableProduct.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| HL7 CSP IG ballot row 128 | Administration-frequency stated: Administration.frequency (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| HL7 CSP IG ballot row 129 | Administration-route stated: Administration.route (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| HL7 CSP IG ballot row 130 | StudyIntervention-label stated: StudyIntervention.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| HL7 CSP IG ballot row 131 | AdministrableProduct-label stated: AdministrableProduct.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| HL7 CSP IG ballot row 133 | Administration-frequency stated: Administration.frequency (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| HL7 CSP IG ballot row 134 | Administration-route stated: Administration.route (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| CDISC DDF-RA v4.0.0 row 124 | StudyIntervention-label stated: StudyIntervention.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| CDISC DDF-RA v4.0.0 row 125 | AdministrableProduct-label stated: AdministrableProduct.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| CDISC DDF-RA v4.0.0 row 127 | Administration-frequency stated: Administration.frequency (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| CDISC DDF-RA v4.0.0 row 128 | Administration-route stated: Administration.route (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| CDISC DDF-RA v4.0.0 row 129 | StudyIntervention-label stated: StudyIntervention.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| CDISC DDF-RA v4.0.0 row 130 | AdministrableProduct-label stated: AdministrableProduct.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| CDISC DDF-RA v4.0.0 row 132 | Administration-frequency stated: Administration.frequency (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| CDISC DDF-RA v4.0.0 row 133 | Administration-route stated: Administration.route (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| CDISC DDF-RA v4.0.0 row 134 | StudyIntervention-label stated: StudyIntervention.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| CDISC DDF-RA v4.0.0 row 135 | AdministrableProduct-label stated: AdministrableProduct.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| CDISC DDF-RA v4.0.0 row 137 | Administration-frequency stated: Administration.frequency (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| CDISC DDF-RA v4.0.0 row 138 | Administration-route stated: Administration.route (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
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.