| # | | 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 resolution date | hl7.fhir.uv.ae-research-backport-ig#current | R4 | The date the adverse event was resolved. |
| 4 | | 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. |
| 5 | | 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. |
| 6 | | 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. |
| 7 | | 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. |
| 8 | | 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. |
| 9 | | 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. |
| 10 | | Note | hl7.fhir.uv.ae-research-backport-ig#current | R4 | Comments made about the adverse event by the performer, subject or other participants. |
| 11 | | Participant | hl7.fhir.uv.ae-research-backport-ig#current | R4 | Indicates who or what participated in the adverse event and how they were involved. |
| 12 | | Research Subject record of subject | hl7.fhir.uv.ae-research-backport-ig#current | R4 | Communicates Research Subject related metadata. |
| 13 | | Resulting Effect | hl7.fhir.uv.ae-research-backport-ig#current | R4 | Information about the condition that occurred as a result of the adverse event. |
| 14 | | 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. |
| 15 | | 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. |
| 16 | | 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. |
| 17 | | Suspect Entity | hl7.fhir.uv.ae-research-backport-ig#current | R4 | Describes the entity that is suspected to have caused the adverse event. |
| 18 | | 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. |