| Source | URL | Version | Realm | Type | Description |
|---|---|---|---|---|---|
| AdverseEvent | |||||
| hl7.fhir.uv.extensions.r4#1.0.0 | http://hl7.org/fhir/StructureDefinition/workflow-episodeOfCare|1.0.0 | 5.0.0 | uv | Reference | Identifies the episode(s) of care that this resource is relevant to. Establishes the EpisodeOfCare as a 'grouper' of resources that are relevant to that episode. Profile Paths: Observation, QuestionnaireResponse, ServiceRequest |
| hl7.fhir.us.cdmh#current | http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-match-confidence|1.0.0 | 4.0.1 | us | code | Death Match Confidence. Profile Paths: AdverseEvent |
| hl7.fhir.us.cdmh#current | http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-source|1.0.0 | 4.0.1 | us | code | Death Source Type. Profile Paths: AdverseEvent |
| hl7.fhir.us.codex-radiation-therapy#current | http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotheraphy-adverse-event-severity-or-grade|1.0.0 | 4.0.1 | us | CodeableConcept | The grade associated with the severity of an adverse event, using CTCAE criteria. The code '0' representing no adverse event may be used to provide positive confirmation that the clinician assessed or considered this particular AE, although the absence of an adverse event is generally not reportable. See https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm Profile Paths: AdverseEvent |
| hl7.fhir.us.ctcae#current | http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation|0.0.1 | 4.0.1 | us | CodeableConcept | A determination if the adverse event is or is not 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. Profile Paths: AdverseEvent |
| hl7.fhir.us.ctcae#current | http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-resolved-date|0.0.1 | 4.0.1 | us | dateTime | The date (and time) when the adverse event ends or returns to baseline (NCI Thesaurus). Profile Paths: AdverseEvent |
| hl7.fhir.us.ctcae#current | http://hl7.org/fhir/us/ctcae/StructureDefinition/ctcae-grade|0.0.1 | 4.0.1 | us | CodeableConcept | The grade associated with the severity of an adverse event, using CTCAE criteria. The code '0' representing no adverse event may be used to provide positive confirmation that the clinician assessed or considered this particular AE, although the absence of an adverse event is generally not reportable. See https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm Profile Paths: AdverseEvent |
| hl7.fhir.us.icsr-ae-reporting#current | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset|1.0.1 | 4.0.1 | us | Age | The age of the patient when the event occurred. Profile Paths: AdverseEvent |
| hl7.fhir.us.pedcan#current | http://hl7.org/fhir/us/pedcan/StructureDefinition/adverse-event-resolved-date|0.1.0 | 4.0.1 | us | dateTime | The date (and time) when the adverse event ends or returns to baseline (NCI Thesaurus). Profile Paths: AdverseEvent |
| hl7.fhir.us.pedcan#current | http://hl7.org/fhir/us/pedcan/StructureDefinition/ctcae-grade|0.1.0 | 4.0.1 | us | CodeableConcept | The grade associated with the severity of an adverse event, using CTCAE criteria. The code '0' representing no adverse event may be used to provide positive confirmation that the clinician assessed or considered this particular AE, although the absence of an adverse event is generally not reportable. See https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study|1.0.0-ballot | 4.0.1 | uv | boolean | Indicates if the subject discontinued the study due to the adverse event. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor|1.0.0-ballot | 4.0.1 | uv | (complex) | The contributing factors suspected to have increased the probability or severity of the adverse event. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study|1.0.0-ballot | 4.0.1 | uv | boolean | Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action|1.0.0-ballot | 4.0.1 | uv | (complex) | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note|1.0.0-ballot | 4.0.1 | uv | Annotation | Comments made about the adverse event by the performer, subject or other participants. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant|1.0.0-ballot | 4.0.1 | uv | (complex) | Indicates who or what participated in the adverse event and how they were involved. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref|1.0.0-ballot | 4.0.1 | uv | Reference | Communicates Research Subject related metadata. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date|1.0.0-ballot | 4.0.1 | uv | dateTime | The date the adverse event was resolved. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect|1.0.0-ballot | 4.0.1 | uv | Reference | Information about the condition that occurred as a result of the adverse event. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria|1.0.0-ballot | 4.0.1 | uv | (complex) | TBD - Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade|1.0.0-ballot | 4.0.1 | uv | CodeableConcept | Describes the severity of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity. For cancer related trials, severity is represented as a grade. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status|1.0.0-ballot | 4.0.1 | uv | code | The current workflow state of the adverse event or potential adverse event. This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info|1.0.0-ballot | 4.0.1 | uv | (complex) | Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-backport-ig#current | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity|1.0.0-ballot | 4.0.1 | uv | (complex) | Describes the entity that is suspected to have caused the adverse event. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-ig#current | http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study|1.0.0-ballot | 5.0.0 | uv | boolean | Indicates if the subject discontinued the study due to the adverse event. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-ig#current | http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria|1.0.0-ballot | 5.0.0 | uv | (complex) | TBD - Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events. Profile Paths: AdverseEvent |
| hl7.fhir.uv.ae-research-ig#current | http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/severity-or-grade|1.0.0-ballot | 5.0.0 | uv | CodeableConcept | Describes the severity of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity. For cancer related trials, severity is represented as a grade. Profile Paths: AdverseEvent |
| AdverseEvent.date | |||||
| hl7.fhir.us.icsr-ae-reporting#current | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration|1.0.1 | 4.0.1 | us | Duration | The duration of the adverse event. Profile Paths: AdverseEvent.date |
| hl7.fhir.us.icsr-ae-reporting#current | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate|1.0.1 | 4.0.1 | us | dateTime | When the event ended. Profile Paths: AdverseEvent.date |
| AdverseEvent.seriousness | |||||
| hl7.fhir.us.icsr-ae-reporting#current | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness|1.0.1 | 4.0.1 | us | CodeableConcept | Additional codes that give more detail around the adverse event seriousness. Profile Paths: AdverseEvent.seriousness |
| AdverseEvent.suspectEntity.causality | |||||
| hl7.fhir.us.cdmh#current | http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause|1.0.0 | 4.0.1 | us | string | Death Cause. Profile Paths: AdverseEvent.suspectEntity.causality |
| hl7.fhir.us.cdmh#current | http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-code|1.0.0 | 4.0.1 | us | code | Death Cause Code. Profile Paths: AdverseEvent.suspectEntity.causality |
| hl7.fhir.us.cdmh#current | http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-confidence|1.0.0 | 4.0.1 | us | code | Death Cause Confidence. Profile Paths: AdverseEvent.suspectEntity.causality |
| hl7.fhir.us.cdmh#current | http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-source|1.0.0 | 4.0.1 | us | code | Death Cause Source. Profile Paths: AdverseEvent.suspectEntity.causality |
| hl7.fhir.us.cdmh#current | http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-type|1.0.0 | 4.0.1 | us | code | Death Cause Type. Profile Paths: AdverseEvent.suspectEntity.causality |