HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT
0.0.1 - DRAFT
HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT
0.0.1 - DRAFT
HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT, published by HL7 International Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/standardhealth/fsh-ae/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-expectation-value-set | Version: 0.0.1 | |||
| Draft as of 2024-02-28 | Computable Name: AdverseEventExpectationVS | |||
An expected adverse event is one whose nature and severity have been previously observed, identified in nature, severity, or frequency, and documented in the investigator brochure, investigational plan, protocol, current consent form, scientific publication, or in other relevant and reliable document. An unexpected adverse event is one that has not been previously observed, whether or not the event was anticipated because of the pharmacologic properties of the study agent or the nature of the medical procedure. This includes events that are more serious than expected or occur more frequently than expected, particularly, any adverse experience, the nature, severity or frequency of which is not consistent with the product label, or with the current investigator brochure for investigational agent; or with the risk information described in the investigational plan or protocol or consent form (NCI Thesaurus).
References
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl| Code | Display |
| C41333 | Expected Adverse Event |
| C41334 | Unexpected Adverse Event |
This value set contains 0 concepts.
| Code | System | Display |
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |