Adverse Events of Special Interest
https://w3id.org/m11-rdf/C217350.C217358
- Definition
- A description of the processes and procedures used to define, measure, confirm, and report the occurrence of adverse events that are of special interest to the specific trial, or state not applicable.
- Namespace
- ICH M11 Section 9 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.9+C217358(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217358 (EVS identifier)
NCIT_C217358 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217350.C217358 (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 |
|---|---|---|---|---|---|---|---|
| 449 | {<Adverse Events of Special Interest>} Or {<Not applicable>} | 9.2.4 Adverse Events of Special Interest | Required | One to one | Text (D) | No |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 9.2.4 Adverse Events of Special Interest 9.2.4 | <Enter Adverse Events of Special Interest> | conditional | p. 53 | evs-label / 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.