AdverseEvent (35)

#	Name	Source	Ver	Description
1	Adverse event caused subject to discontinue the study	hl7.fhir.uv.ae-research-backport-ig#current	R4	Indicates if the subject discontinued the study due to the adverse event.
2	Adverse event caused subject to discontinue the study	hl7.fhir.uv.ae-research-ig#current	R5	Indicates if the subject discontinued the study due to the adverse event.
3	Adverse Event Expectation	hl7.fhir.us.ctcae#current	R4	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.
4	Adverse Event resolution date	hl7.fhir.uv.ae-research-backport-ig#current	R4	The date the adverse event was resolved.
5	Adverse Event Resolved Date	hl7.fhir.us.ctcae#current	R4	The date (and time) when the adverse event ends or returns to baseline (NCI Thesaurus).
6	Adverse Event Resolved Date	hl7.fhir.us.pedcan#current	R4	The date (and time) when the adverse event ends or returns to baseline (NCI Thesaurus).
7	AgeAtTimeOfOnset	hl7.fhir.us.icsr-ae-reporting#current	R4	The age of the patient when the event occurred.
8	Contributing Factor	hl7.fhir.uv.ae-research-backport-ig#current	R4	The contributing factors suspected to have increased the probability or severity of the adverse event.
9	Criteria reviewed in determining serious adverse event	hl7.fhir.uv.ae-research-backport-ig#current	R4	TBD - Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
10	Criteria reviewed in determining serious adverse event	hl7.fhir.uv.ae-research-ig#current	R5	TBD - Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
11	CTC Adverse Event Grade	hl7.fhir.us.ctcae#current	R4	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
12	CTC Adverse Event Grade	hl7.fhir.us.pedcan#current	R4	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
13	DeathCause	hl7.fhir.us.cdmh#current	R4	Death Cause.
14	Episode of care	hl7.fhir.uv.extensions.r4#1.0.0	R4	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.
15	EventDuration	hl7.fhir.us.icsr-ae-reporting#current	R4	The duration of the adverse event.
16	EventEndDate	hl7.fhir.us.icsr-ae-reporting#current	R4	When the event ended.
17	EventSeriousness	hl7.fhir.us.icsr-ae-reporting#current	R4	Additional codes that give more detail around the adverse event seriousness.
18	Expected In Research Study	hl7.fhir.uv.ae-research-backport-ig#current	R4	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.
19	Mitigating Action	hl7.fhir.uv.ae-research-backport-ig#current	R4	Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.
20	Note	hl7.fhir.uv.ae-research-backport-ig#current	R4	Comments made about the adverse event by the performer, subject or other participants.
21	Participant	hl7.fhir.uv.ae-research-backport-ig#current	R4	Indicates who or what participated in the adverse event and how they were involved.
22	PCORNet Death Cause Code	hl7.fhir.us.cdmh#current	R4	Death Cause Code.
23	PCORNet Death Cause Confidence	hl7.fhir.us.cdmh#current	R4	Death Cause Confidence.
24	PCORNet Death Cause Source	hl7.fhir.us.cdmh#current	R4	Death Cause Source.
25	PCORNet Death Cause Type	hl7.fhir.us.cdmh#current	R4	Death Cause Type.
26	PCORNet Death Match Confidence	hl7.fhir.us.cdmh#current	R4	Death Match Confidence.
27	PCORNet Death Source Code	hl7.fhir.us.cdmh#current	R4	Death Source Type.
28	Radiotherapy Adverse Event Grade	hl7.fhir.us.codex-radiation-therapy#current	R4	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
29	Research Subject record of subject	hl7.fhir.uv.ae-research-backport-ig#current	R4	Communicates Research Subject related metadata.
30	Resulting Effect	hl7.fhir.uv.ae-research-backport-ig#current	R4	Information about the condition that occurred as a result of the adverse event.
31	Severity Or Grade	hl7.fhir.uv.ae-research-ig#current	R5	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.
32	Severity Or Grade	hl7.fhir.uv.ae-research-backport-ig#current	R4	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.
33	Supporting information relevant to the event	hl7.fhir.uv.ae-research-backport-ig#current	R4	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.
34	Suspect Entity	hl7.fhir.uv.ae-research-backport-ig#current	R4	Describes the entity that is suspected to have caused the adverse event.
35	Workflow Status	hl7.fhir.uv.ae-research-backport-ig#current	R4	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.

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C D

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S C (2)

S C (3)

S C (2)

S C (3)

S C (2)

S C (3)

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S C B M (3)

C B M (2)

S C B M (3)

S C B M (4)

S C B M (3)

S C (3)

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F (2)

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C (2)

S C (4)

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S C B M (6)

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F (3)

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C (3)

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B M

C B M

B M

S: There is slicing defined in the element(s)
C: There is cardinality erstrictions defined in the element(s)
I: There is invariants defined in the element(s)
F: There is a fixed or pattern value defined in the element(s)
D: There is document provided in the element(s)
B: There is terminology bindings defined in the element(s)
M: At least one of the element(s) has must-support = true
(N): The number of elements if > 1

Produced 08 Sep 2023