Prohibited Concomitant Therapy
https://w3id.org/m11-rdf/C217347.C218762
- Definition
- Concomitant therapy that is banned from use in the trial.
- Namespace
- ICH M11 Section 6 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.6+C218762(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218762 (EVS identifier)
NCIT_C218762 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217347.C218762 (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 |
|---|---|---|---|---|---|---|---|
| 354 | {<Prohibited Concomitant Therapy>} | 6.10.1 Prohibited Concomitant Therapy | Conditional: when any prohibited concomitant therapies are defined | One to one | Text (D) | No |
In the ICH M11 Template
The Template heading of 6.10.1 Prohibited Concomitant Therapy is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 6.10.1 Prohibited Concomitant Therapy 6.10.1 | <Enter Prohibited Concomitant Therapy> | conditional | p. 42 | 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 214 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
| CDISC DDF-RA v4.0.0 row 217 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
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.