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.

BlockTermSectionConformanceCardinalityData typeValue code listRepeating / 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 characteristicOne to Row Heading; One to Primary Objective Table; Project IdentifierText (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 SecondaryOne to Row Heading, One to Secondary Objective Table, Project IdentifierText (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 estimandOne to Row Heading; One to Exploratory Objective Table; Project IdentifierText (D)Yes, repeatable for each numbered Exploratory Objective.

In the ICH M11 Template

SectionFieldTemplatePageLinked by
3.1.1 Primary Objective 3.1.1<Enter Treatment>conditionalp. 28ts-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.

SourceUSDM attribute (usdm-rdf)IdentifiedTarget pathCondition
HL7 CSP IG ballot
row 120
StudyIntervention-label
stated: StudyIntervention.label (attribute name)
by-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@labelStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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-codeStudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decodeStudyVersion/@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.