FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

Publication Build: This will be filled in by the publication tooling

## Resource Profile: OncoAdverseEvent - XML Profile

Draft as of 2025-04-03

XML representation of the onco-adverse-event resource profile.

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    <StructureDefinition xmlns="http://hl7.org/fhir">
      <id value="onco-adverse-event"/>
      <text>
        <status value="extensions"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition onco-adverse-event</b></p><a name="onco-adverse-event"> </a><a name="hconco-adverse-event"> </a><a name="onco-adverse-event-en-US"> </a><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Le nom logique de lélément">Nom</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Drapeaux</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description et contraintes</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Ressource" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent">AdverseEvent</a><a name="AdverseEvent"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/adverseevent.html">AdverseEvent</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Medical care, research study or other healthcare event causing physical injury</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Extension simple" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.extension">Slices pour extension</a><a name="AdverseEvent.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.extension:end-date" title="Extension URL = https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date">extension:end-date</a><a name="AdverseEvent.extension.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#dateTime">dateTime</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">End date<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-adverse-event-end-date.html">https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date</a></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.event" title="The international MedDRA code (version 12.0) is used to describe the Adverse Event (AE) occurring during treatment.">event</a><a name="AdverseEvent.event"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Term to describe the adverse event<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-AdverseEventCode.html" title="https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode">Adverse Event Code Value Set</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.">extensible</a>)</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.subject">subject</a><a name="AdverseEvent.subject"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a href="StructureDefinition-onco-patient.html">Oncology Patient</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Subject impacted by event</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.date" title="Date of diagnosis of the adverse event.">date</a><a name="AdverseEvent.date"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#dateTime">dateTime</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date of diagnosis</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.seriousness" title="The Common Terminology Criteria For Adverse Events (CTCAE version 5.0) grade is used to define the severity of the AE.">seriousness</a><a name="AdverseEvent.seriousness"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Grade of the adverse event<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-AdverseEventGrade.html" title="https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade">Adverse Event Grade Value Set</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.seriousness.coding">coding</a><a name="AdverseEvent.seriousness.coding"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.seriousness.coding.code">code</a><a name="AdverseEvent.seriousness.coding.code"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Symbol in syntax defined by the system</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.suspectEntity">suspectEntity</a><a name="AdverseEvent.suspectEntity"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.suspectEntity.instance">instance</a><a name="AdverseEvent.suspectEntity.instance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a href="StructureDefinition-onco-medication-statement.html">Oncology-related Medication Statement</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Refers to the specific entity that caused the adverse event</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-onco-adverse-event-definitions.html#AdverseEvent.subjectMedicalHistory">subjectMedicalHistory</a><a name="AdverseEvent.subjectMedicalHistory"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a href="StructureDefinition-tumor-pathology-event.html">Tumor Pathology Event</a>)</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">AdverseEvent.subjectMedicalHistory</span></td></tr>
    <tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
      </text>
      <url
           value="https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-adverse-event"/>
      <version value="1.1.0"/>
      <name value="OncoAdverseEvent"/>
      <title value="Oncologic Adverse Event"/>
      <status value="draft"/>
      <date value="2025-04-03T14:14:07+02:00"/>
      <publisher value="institutcancer"/>
      <contact>
        <name value="institutcancer"/>
        <telecom>
          <system value="url"/>
          <value value="http://cancer.fr"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="osiris@institutcancer.fr"/>
        </telecom>
      </contact>
      <contact>
        <name value="Aurélien JOBARD"/>
        <telecom>
          <system value="email"/>
          <value value="osiris@institutcancer.fr"/>
        </telecom>
      </contact>
      <description
                   value="Adverse event related to a cancer-related treatment associated to a grade from MEDDRA terminology (ex: 10047700: &quot;Vomiting&quot;)."/>
      <fhirVersion value="4.0.1"/>
      <mapping>
        <identity value="fhir-osiris-adverseevent"/>
        <uri value="AdverseEvent"/>
        <name value="Fhir-osiris adverse event to osiris"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <uri value="http://hl7.org/fhir/fivews"/>
        <name value="FiveWs Pattern Mapping"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <uri value="http://hl7.org/v3"/>
        <name value="RIM Mapping"/>
      </mapping>
      <kind value="resource"/>
      <abstract value="false"/>
      <type value="AdverseEvent"/>
      <baseDefinition
                      value="http://hl7.org/fhir/StructureDefinition/AdverseEvent"/>
      <derivation value="constraint"/>
      <snapshot>
        <extension
                   url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
          <valueString value="4.0.1"/>
        </extension>
        <element id="AdverseEvent">
          <path value="AdverseEvent"/>
          <short
                 value="Medical care, research study or other healthcare event causing physical injury"/>
          <definition
                      value="Actual or  potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death."/>
          <alias value="AE"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="AdverseEvent"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <constraint>
            <key value="dom-2"/>
            <severity value="error"/>
            <human
                   value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
            <expression value="contained.contained.empty()"/>
            <xpath value="not(parent::f:contained and f:contained)"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="dom-3"/>
            <severity value="error"/>
            <human
                   value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
            <expression
                        value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
            <xpath
                   value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="dom-4"/>
            <severity value="error"/>
            <human
                   value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
            <expression
                        value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
            <xpath
                   value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="dom-5"/>
            <severity value="error"/>
            <human
                   value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
            <expression value="contained.meta.security.empty()"/>
            <xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
              <valueBoolean value="true"/>
            </extension>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
              <valueMarkdown
                             value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
            </extension>
            <key value="dom-6"/>
            <severity value="warning"/>
            <human
                   value="A resource should have narrative for robust management"/>
            <expression value="text.`div`.exists()"/>
            <xpath value="exists(f:text/h:div)"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="Entity. Role, or Act"/>
          </mapping>
        </element>
        <element id="AdverseEvent.id">
          <path value="AdverseEvent.id"/>
          <short value="Logical id of this artifact"/>
          <definition
                      value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
          <comment
                   value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.meta">
          <path value="AdverseEvent.meta"/>
          <short value="Metadata about the resource"/>
          <definition
                      value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.meta"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Meta"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.implicitRules">
          <path value="AdverseEvent.implicitRules"/>
          <short value="A set of rules under which this content was created"/>
          <definition
                      value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
          <comment
                   value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.implicitRules"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="uri"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.language">
          <path value="AdverseEvent.language"/>
          <short value="Language of the resource content"/>
          <definition
                      value="The base language in which the resource is written."/>
          <comment
                   value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.language"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="code"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
              <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/>
            </extension>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Language"/>
            </extension>
            <strength value="preferred"/>
            <description value="A human language."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
          </binding>
        </element>
        <element id="AdverseEvent.text">
          <path value="AdverseEvent.text"/>
          <short value="Text summary of the resource, for human interpretation"/>
          <definition
                      value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
          <comment
                   value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded information is added later."/>
          <alias value="narrative"/>
          <alias value="html"/>
          <alias value="xhtml"/>
          <alias value="display"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="DomainResource.text"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Narrative"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="Act.text?"/>
          </mapping>
        </element>
        <element id="AdverseEvent.contained">
          <path value="AdverseEvent.contained"/>
          <short value="Contained, inline Resources"/>
          <definition
                      value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/>
          <comment
                   value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/>
          <alias value="inline resources"/>
          <alias value="anonymous resources"/>
          <alias value="contained resources"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="DomainResource.contained"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Resource"/>
          </type>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="AdverseEvent.extension">
          <path value="AdverseEvent.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <ordered value="false"/>
            <rules value="open"/>
          </slicing>
          <short value="Extension"/>
          <definition value="An Extension"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="DomainResource.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="AdverseEvent.extension:end-date">
          <path value="AdverseEvent.extension"/>
          <sliceName value="end-date"/>
          <short value="End date"/>
          <definition value="End date of the adverse event"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="DomainResource.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
            <profile
                     value="https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date"/>
          </type>
          <condition value="ele-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.AdverseEvent_EndDate"/>
          </mapping>
        </element>
        <element id="AdverseEvent.modifierExtension">
          <path value="AdverseEvent.modifierExtension"/>
          <short value="Extensions that cannot be ignored"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="DomainResource.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="AdverseEvent.identifier">
          <path value="AdverseEvent.identifier"/>
          <short value="Business identifier for the event"/>
          <definition
                      value="Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server."/>
          <comment
                   value="This is a business identifier, not a resource identifier (see [discussion](http://hl7.org/fhir/R4/resource.html#identifiers)).  It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types.  For example, multiple Patient and a Person resource instance might share the same social insurance number."/>
          <requirements
                        value="Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.identifier"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Identifier"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.actuality">
          <path value="AdverseEvent.actuality"/>
          <short value="actual | potential"/>
          <definition
                      value="Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.actuality"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="code"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen."/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="AdverseEventActuality"/>
            </extension>
            <strength value="required"/>
            <description
                         value="Overall nature of the adverse event, e.g. real or potential."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1"/>
          </binding>
          <mapping>
            <identity value="w5"/>
            <map value="FiveWs.class"/>
          </mapping>
        </element>
        <element id="AdverseEvent.category">
          <path value="AdverseEvent.category"/>
          <short
                 value="product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment"/>
          <definition
                      value="The overall type of event, intended for search and filtering purposes."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="AdverseEvent.category"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="AdverseEventCategory"/>
            </extension>
            <strength value="extensible"/>
            <description
                         value="Overall categorization of the event, e.g. product-related or situational."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/adverse-event-category"/>
          </binding>
          <mapping>
            <identity value="w5"/>
            <map value="FiveWs.class"/>
          </mapping>
        </element>
        <element id="AdverseEvent.event">
          <path value="AdverseEvent.event"/>
          <short value="Term to describe the adverse event"/>
          <definition
                      value="The international MedDRA code (version 12.0) is used to describe the Adverse Event (AE) occurring during treatment."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.event"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode"/>
          </binding>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.AdverseEvent_Code"/>
          </mapping>
          <mapping>
            <identity value="w5"/>
            <map value="FiveWs.what[x]"/>
          </mapping>
        </element>
        <element id="AdverseEvent.subject">
          <path value="AdverseEvent.subject"/>
          <short value="Subject impacted by event"/>
          <definition value="This subject or group impacted by the event."/>
          <comment
                   value="If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject."/>
          <requirements
                        value="Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital."/>
          <alias value="patient"/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.subject"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-patient"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.Patient_Id"/>
          </mapping>
          <mapping>
            <identity value="w5"/>
            <map value="FiveWs.who"/>
          </mapping>
        </element>
        <element id="AdverseEvent.encounter">
          <path value="AdverseEvent.encounter"/>
          <short value="Encounter created as part of"/>
          <definition
                      value="The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated."/>
          <comment
                   value="This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter.  For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context.  If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.encounter"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Encounter"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="w5"/>
            <map value="FiveWs.context"/>
          </mapping>
        </element>
        <element id="AdverseEvent.date">
          <path value="AdverseEvent.date"/>
          <short value="Date of diagnosis"/>
          <definition value="Date of diagnosis of the adverse event."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.date"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.AdverseEvent_Date"/>
          </mapping>
          <mapping>
            <identity value="w5"/>
            <map value="FiveWs.init"/>
          </mapping>
        </element>
        <element id="AdverseEvent.detected">
          <path value="AdverseEvent.detected"/>
          <short value="When the event was detected"/>
          <definition
                      value="Estimated or actual date the AdverseEvent began, in the opinion of the reporter."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.detected"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.recordedDate">
          <path value="AdverseEvent.recordedDate"/>
          <short value="When the event was recorded"/>
          <definition
                      value="The date on which the existence of the AdverseEvent was first recorded."/>
          <comment
                   value="The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update.  The date of the last record modification can be retrieved from the resource metadata."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.recordedDate"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="w5"/>
            <map value="FiveWs.recorded"/>
          </mapping>
        </element>
        <element id="AdverseEvent.resultingCondition">
          <path value="AdverseEvent.resultingCondition"/>
          <short value="Effect on the subject due to this event"/>
          <definition
                      value="Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical)."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="AdverseEvent.resultingCondition"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Condition"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.location">
          <path value="AdverseEvent.location"/>
          <short value="Location where adverse event occurred"/>
          <definition
                      value="The information about where the adverse event occurred."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.location"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Location"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.seriousness">
          <path value="AdverseEvent.seriousness"/>
          <short value="Grade of the adverse event"/>
          <definition
                      value="The Common Terminology Criteria For Adverse Events (CTCAE version 5.0) grade is used to define the severity of the AE."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.seriousness"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade"/>
          </binding>
        </element>
        <element id="AdverseEvent.seriousness.id">
          <path value="AdverseEvent.seriousness.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.extension">
          <path value="AdverseEvent.seriousness.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.coding">
          <path value="AdverseEvent.seriousness.coding"/>
          <short value="Code defined by a terminology system"/>
          <definition
                      value="A reference to a code defined by a terminology system."/>
          <comment
                   value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
          <requirements
                        value="Allows for alternative encodings within a code system, and translations to other code systems."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="CodeableConcept.coding"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Coding"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.1-8, C*E.10-22"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="union(., ./translation)"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.coding.id">
          <path value="AdverseEvent.seriousness.coding.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.coding.extension">
          <path value="AdverseEvent.seriousness.coding.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.coding.system">
          <path value="AdverseEvent.seriousness.coding.system"/>
          <short value="Identity of the terminology system"/>
          <definition
                      value="The identification of the code system that defines the meaning of the symbol in the code."/>
          <comment
                   value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously."/>
          <requirements
                        value="Need to be unambiguous about the source of the definition of the symbol."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.system"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="uri"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.3"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./codeSystem"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.coding.version">
          <path value="AdverseEvent.seriousness.coding.version"/>
          <short value="Version of the system - if relevant"/>
          <definition
                      value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged."/>
          <comment
                   value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.version"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.7"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./codeSystemVersion"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.coding.code">
          <path value="AdverseEvent.seriousness.coding.code"/>
          <short value="Symbol in syntax defined by the system"/>
          <definition
                      value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)."/>
          <requirements
                        value="Need to refer to a particular code in the system."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.code"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="code"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.AdverseEvent_Grade"/>
          </mapping>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.1"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./code"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.coding.display">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <path value="AdverseEvent.seriousness.coding.display"/>
          <short value="Representation defined by the system"/>
          <definition
                      value="A representation of the meaning of the code in the system, following the rules of the system."/>
          <requirements
                        value="Need to be able to carry a human-readable meaning of the code for readers that do not know  the system."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.display"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.2 - but note this is not well followed"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="CV.displayName"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.coding.userSelected">
          <path value="AdverseEvent.seriousness.coding.userSelected"/>
          <short value="If this coding was chosen directly by the user"/>
          <definition
                      value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)."/>
          <comment
                   value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely."/>
          <requirements
                        value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.userSelected"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="Sometimes implied by being first"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="CD.codingRationale"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [     fhir:source &quot;true&quot;;     fhir:target dt:CDCoding.codingRationale\#O   ]"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness.text">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <path value="AdverseEvent.seriousness.text"/>
          <short value="Plain text representation of the concept"/>
          <definition
                      value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
          <comment
                   value="Very often the text is the same as a displayName of one of the codings."/>
          <requirements
                        value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="CodeableConcept.text"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.9. But note many systems use C*E.2 for this"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map
                 value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
          </mapping>
        </element>
        <element id="AdverseEvent.severity">
          <path value="AdverseEvent.severity"/>
          <short value="mild | moderate | severe"/>
          <definition
                      value="Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.severity"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="AdverseEventSeverity"/>
            </extension>
            <strength value="required"/>
            <description
                         value="The severity of the adverse event itself, in direct relation to the subject."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1"/>
          </binding>
        </element>
        <element id="AdverseEvent.outcome">
          <path value="AdverseEvent.outcome"/>
          <short
                 value="resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown"/>
          <definition
                      value="Describes the type of outcome from the adverse event."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.outcome"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="AdverseEventOutcome"/>
            </extension>
            <strength value="required"/>
            <description value="TODO (and should this be required?)."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1"/>
          </binding>
        </element>
        <element id="AdverseEvent.recorder">
          <path value="AdverseEvent.recorder"/>
          <short value="Who recorded the adverse event"/>
          <definition
                      value="Information on who recorded the adverse event.  May be the patient or a practitioner."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.recorder"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Patient"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="w5"/>
            <map value="FiveWs.author"/>
          </mapping>
        </element>
        <element id="AdverseEvent.contributor">
          <path value="AdverseEvent.contributor"/>
          <short
                 value="Who  was involved in the adverse event or the potential adverse event"/>
          <definition
                      value="Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities.  Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness)."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="AdverseEvent.contributor"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Device"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.suspectEntity">
          <path value="AdverseEvent.suspectEntity"/>
          <short value="The suspected agent causing the adverse event"/>
          <definition
                      value="Describes the entity that is suspected to have caused the adverse event."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="AdverseEvent.suspectEntity"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.suspectEntity.id">
          <path value="AdverseEvent.suspectEntity.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="AdverseEvent.suspectEntity.extension">
          <path value="AdverseEvent.suspectEntity.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="AdverseEvent.suspectEntity.modifierExtension">
          <path value="AdverseEvent.suspectEntity.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="AdverseEvent.suspectEntity.instance">
          <path value="AdverseEvent.suspectEntity.instance"/>
          <short
                 value="Refers to the specific entity that caused the adverse event"/>
          <definition
                      value="Identifies the actual instance of what caused the adverse event.  May be a substance, medication, medication administration, medication statement or a device."/>
          <alias value="Substance or Medication or Device"/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.suspectEntity.instance"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-medication-statement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.Treatment_Ref"/>
          </mapping>
        </element>
        <element id="AdverseEvent.suspectEntity.causality">
          <path value="AdverseEvent.suspectEntity.causality"/>
          <short value="Information on the possible cause of the event"/>
          <definition value="Information on the possible cause of the event."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="AdverseEvent.suspectEntity.causality"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.suspectEntity.causality.id">
          <path value="AdverseEvent.suspectEntity.causality.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="AdverseEvent.suspectEntity.causality.extension">
          <path value="AdverseEvent.suspectEntity.causality.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="AdverseEvent.suspectEntity.causality.modifierExtension">
          <path value="AdverseEvent.suspectEntity.causality.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="AdverseEvent.suspectEntity.causality.assessment">
          <path value="AdverseEvent.suspectEntity.causality.assessment"/>
          <short value="Assessment of if the entity caused the event"/>
          <definition value="Assessment of if the entity caused the event."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.suspectEntity.causality.assessment"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="AdverseEventCausalityAssessment"/>
            </extension>
            <strength value="example"/>
            <description
                         value="Codes for the assessment of whether the entity caused the event."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"/>
          </binding>
        </element>
        <element id="AdverseEvent.suspectEntity.causality.productRelatedness">
          <path value="AdverseEvent.suspectEntity.causality.productRelatedness"/>
          <short value="AdverseEvent.suspectEntity.causalityProductRelatedness"/>
          <definition
                      value="AdverseEvent.suspectEntity.causalityProductRelatedness."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path
                  value="AdverseEvent.suspectEntity.causality.productRelatedness"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.suspectEntity.causality.author">
          <path value="AdverseEvent.suspectEntity.causality.author"/>
          <short value="AdverseEvent.suspectEntity.causalityAuthor"/>
          <definition value="AdverseEvent.suspectEntity.causalityAuthor."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.suspectEntity.causality.author"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.suspectEntity.causality.method">
          <path value="AdverseEvent.suspectEntity.causality.method"/>
          <short value="ProbabilityScale | Bayesian | Checklist"/>
          <definition value="ProbabilityScale | Bayesian | Checklist."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="AdverseEvent.suspectEntity.causality.method"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="AdverseEventCausalityMethod"/>
            </extension>
            <strength value="example"/>
            <description value="TODO."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/adverse-event-causality-method"/>
          </binding>
        </element>
        <element id="AdverseEvent.subjectMedicalHistory">
          <path value="AdverseEvent.subjectMedicalHistory"/>
          <short value="AdverseEvent.subjectMedicalHistory"/>
          <definition value="AdverseEvent.subjectMedicalHistory."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="AdverseEvent.subjectMedicalHistory"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/tumor-pathology-event"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.TumorPathologyEvent_Ref"/>
          </mapping>
        </element>
        <element id="AdverseEvent.referenceDocument">
          <path value="AdverseEvent.referenceDocument"/>
          <short value="AdverseEvent.referenceDocument"/>
          <definition value="AdverseEvent.referenceDocument."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="AdverseEvent.referenceDocument"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="AdverseEvent.study">
          <path value="AdverseEvent.study"/>
          <short value="AdverseEvent.study"/>
          <definition value="AdverseEvent.study."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="AdverseEvent.study"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
      </snapshot>
      <differential>
        <element id="AdverseEvent">
          <path value="AdverseEvent"/>
        </element>
        <element id="AdverseEvent.extension">
          <path value="AdverseEvent.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <ordered value="false"/>
            <rules value="open"/>
          </slicing>
        </element>
        <element id="AdverseEvent.extension:end-date">
          <path value="AdverseEvent.extension"/>
          <sliceName value="end-date"/>
          <short value="End date"/>
          <definition value="End date of the adverse event"/>
          <min value="0"/>
          <max value="1"/>
          <type>
            <code value="Extension"/>
            <profile
                     value="https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date"/>
          </type>
          <mustSupport value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.AdverseEvent_EndDate"/>
          </mapping>
        </element>
        <element id="AdverseEvent.event">
          <path value="AdverseEvent.event"/>
          <short value="Term to describe the adverse event"/>
          <definition
                      value="The international MedDRA code (version 12.0) is used to describe the Adverse Event (AE) occurring during treatment."/>
          <min value="1"/>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode"/>
          </binding>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.AdverseEvent_Code"/>
          </mapping>
        </element>
        <element id="AdverseEvent.subject">
          <path value="AdverseEvent.subject"/>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-patient"/>
          </type>
          <mustSupport value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.Patient_Id"/>
          </mapping>
        </element>
        <element id="AdverseEvent.date">
          <path value="AdverseEvent.date"/>
          <short value="Date of diagnosis"/>
          <definition value="Date of diagnosis of the adverse event."/>
          <min value="1"/>
          <mustSupport value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.AdverseEvent_Date"/>
          </mapping>
        </element>
        <element id="AdverseEvent.seriousness">
          <path value="AdverseEvent.seriousness"/>
          <short value="Grade of the adverse event"/>
          <definition
                      value="The Common Terminology Criteria For Adverse Events (CTCAE version 5.0) grade is used to define the severity of the AE."/>
          <min value="1"/>
          <mustSupport value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade"/>
          </binding>
        </element>
        <element id="AdverseEvent.seriousness.coding.code">
          <path value="AdverseEvent.seriousness.coding.code"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.AdverseEvent_Grade"/>
          </mapping>
        </element>
        <element id="AdverseEvent.suspectEntity.instance">
          <path value="AdverseEvent.suspectEntity.instance"/>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-medication-statement"/>
          </type>
          <mustSupport value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.Treatment_Ref"/>
          </mapping>
        </element>
        <element id="AdverseEvent.subjectMedicalHistory">
          <path value="AdverseEvent.subjectMedicalHistory"/>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/tumor-pathology-event"/>
          </type>
          <mustSupport value="true"/>
          <mapping>
            <identity value="fhir-osiris-adverseevent"/>
            <map value="OSIRIS_pivot_AdverseEvent.TumorPathologyEvent_Ref"/>
          </mapping>
        </element>
      </differential>
    </StructureDefinition>