adverse-event-clinical-research-outcomes
type: ValueSet
node role: treeRoot
id:
  v: adverse-event-clinical-research-outcomes
meta:
  profile:
    v: http://hl7.org/fhir/StructureDefinition/shareablevalueset
    link: http://hl7.org/fhir/StructureDefinition/shareablevalueset
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ValueSet adverse-event-clinical-research-outcomes Profile: Shareable ValueSet Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version ∅ Code Display C48275 Fatal C49494 Not recovering/not resolved C49495 Recovered/Resolved with sequelae C49498 Recovered/Resolved C49496 Recovering/Resolving
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
  value: code
    v: brr
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
  value: integer
    v: 1
url:
  v: http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes
identifier:
  system:
    v: urn:ietf:rfc:3986
  value:
    v: urn:oid:2.16.840.1.113883.11.21025
version:
  v: 1.0.0
name:
  v: AdverseEventClinicalResearchOutcomes
title:
  v: Adverse Event Clinical Research Outcomes
status:
  v: active
experimental:
  v: false
date:
  v: 2023-07-28T19:27:19+00:00
publisher:
  v: Health Level Seven International
contact:
  telecom:
    system:
      v: url
    value:
      v: http://hl7.org
  telecom:
    system:
      v: email
description:
  v: 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.
copyright:
  v: 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
compose:
  include:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    concept:
      code:
        v: C48275
      display:
        v: Fatal
    concept:
      code:
        v: C49494
      display:
        v: Not recovering/not resolved
    concept:
      code:
        v: C49495
      display:
        v: Recovered/Resolved with sequelae
    concept:
      code:
        v: C49498
      display:
        v: Recovered/Resolved
    concept:
      code:
        v: C49496
      display:
        v: Recovering/Resolving