HL7 Terminology (THO)
6.3.0 - UTG Consensus Review Change Request UP-676 International flag

HL7 Terminology (THO), published by HL7 International - Vocabulary Work Group. This guide is not an authorized publication; it is the continuous build for version 6.3.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/UTG/ and changes regularly. See the Directory of published versions

ValueSet: Adverse Event Clinical Research Outcomes

Official URL: http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes Version: 1.0.0
Active as of 2023-07-28 Maturity Level: 1 Responsible: Health Level Seven International Computable Name: AdverseEventClinicalResearchOutcomes
Other Identifiers: OID:2.16.840.1.113883.11.21025

Copyright/Legal: This material derives from the HL7 Terminology THO. THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html

This value set includes codes that describe the type of outcome from the adverse event as typically used in reporting for Clinical Research, post-market surveillance (e.g. Medwatch forms). NCI codes used here This list originates from the ICH E2B R3 (https://database.ich.org/sites/default/files/E2D_Guideline.pdf), specifically CDISC CL.C66768.OUT. For information on ICH see https://admin.ich.org/sites/default/files/inline-files/OID_Information_Paper_1.pdf from the INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) document ICH E2B(R3), the Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide Data Elements and Message Specification, and ICH M8, the Electronic Common Technical Document.

References

This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version Not Stated (use latest from terminology server)
    CodeDisplay
    C48275Fatal
    C49494Not recovering/not resolved
    C49495Recovered/Resolved with sequelae
    C49498Recovered/Resolved
    C49496Recovering/Resolving

 

Expansion

Expansion from tx.fhir.org based on fragment NCI Thesaurus version null

This value set contains 5 concepts

SystemCodeDisplay (en)JSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C48275Death Related to Adverse Event
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C49494Not recovering/not resolved
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C49495Recovered/Resolved with sequelae
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C49498Recovered/Resolved
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C49496Recovering/Resolving

Description of the above table(s).

History

DateActionAuthorCustodianComment
2024-03-02createBret HealeBRRAdverseEvent Clinical Research value sets; up-485