Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ResearchStudy 346485</b></p><a name="346485"> </a><a name="hc346485"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 9; Last updated: 2025-07-17 12:25:39+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-study-registry-record.html">StudyRegistryRecord</a></p></div><p><b>ResearchStudyIsLowInterventionTrial</b>: false</p><p><b>Artifact Author</b>: Computable Publishing®: CTIS-to-FEvIR Converter: </p><p><b>ArtifactPublicationStatus</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}">Active</span></p><p><b>url</b>: <a href="https://fevir.net/resources/ResearchStudy/346485">https://fevir.net/resources/ResearchStudy/346485</a></p><p><b>identifier</b>: FEvIR Object Identifier/346485, <code>https://euclinicaltrials.eu/ctis</code>/2024-516402-32-00 (use: official, ), <code>https://clinicaltrials.gov</code>/NCT05726916 (use: official, )</p><p><b>name</b>: CTIS_2024_516402_32_00_FHIR_Transform</p><p><b>title</b>: Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU)</p><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/title-type primary}">Public title</span></p><p><b>value</b>: Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU)</p></blockquote><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/title-type short-title}">Short title</span></p><p><b>value</b>: APHP211039</p></blockquote><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/title-type language}">French</span></p><p><b>value</b>: Eculizumab dans le syndrome hémolytique et urémique associé à l'urgence hypertensive: essai contrôlé multicentrique randomisé (HYPERSHU)</p></blockquote><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/title-type language}">French of public title</span></p><p><b>value</b>: Eculizumab dans le syndrome hémolytique et urémique associé à l'urgence hypertensive: essai contrôlé multicentrique randomisé (HYPERSHU)</p></blockquote><p><b>citeAs</b>: </p><div><p>Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU) [Database Entry: FHIR ResearchStudy Resource]. Contributors: Computable Publishing®: CTIS-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 346485. Revised 2025-07-17. Available at: https://fevir.net/resources/ResearchStudy/346485. Computable resource at: https://fevir.net/resources/ResearchStudy/346485#json.</p>
</div><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Transforms</p><p><b>target</b>: <a href="https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-516402-32-00">https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-516402-32-00</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Transformed With</p><p><b>target</b>: null @ https://fevir.net</p></blockquote><p><b>status</b>: Active</p><p><b>condition</b>: <span title="Codes:">Adult patients with aHUS associated with HE and severe kidney involvement (needing dialysis or serum creatinine ≥ 354μM)</span>, <span title="Codes:{https://www.meddra.org 10079840}">Atypical haemolytic uraemic syndrome</span></p><p><b>period</b>: 2024-02-13 --> 2027-02-13</p><blockquote><p><b>associatedParty</b></p><p><b>name</b>: DGOS - French Ministry of Health</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role funding-source}">Funding source</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Assistance Publique Hopitaux De Paris</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role sponsor}">Sponsor</span></p><p><b>party</b>: <a href="#hc346485/organization-554686">Assistance Publique Hopitaux De Paris</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Dr El Karoui Khalil</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role general-contact}">public contact</span></p><p><b>party</b>: <a href="#hc346485/contact-190857">Dr El Karoui Khalil khalil.el-karoui@aphp.fr</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Dr El Karoui Khalil</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role general-contact}">scientific contact</span></p><p><b>party</b>: <a href="#hc346485/contact-190858">Dr El Karoui Khalil khalil.el-karoui@aphp.fr</a></p></blockquote><h3>ProgressStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>State</b></td><td><b>Actual</b></td><td><b>Period</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/research-study-status overall-study}">Overall study</span></td><td>false</td><td>2024-02-13 --> 2027-02-13</td></tr></table><h3>Recruitments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Eligibility</b></td></tr><tr><td style="display: none">*</td><td><a href="Group-346486.html">CTIS2024-516402-32-00 Eligibility Criteria</a></td></tr></table><blockquote><p><b>objective</b></p><p><b>name</b>: To demonstrate the efficacy of early Eculizumab administration added on standard of care BP control on dialysis-dependence at month 6 in HEaHUS patients with severely impaired initial renal function.</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type primary}">Primary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To evaluate the role of complement biomarkers in predicting therapeutic response</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To evaluate the frequency of complement genetic rare variants in this population</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To evaluate the efficacy of early eculizumab administration added on standard of care BP control on 3-month (W13) and 12 months renal replacement therapy risk</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To evaluate the frequency of severe infections in both groups</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To evaluate the time to resolution of hemolysis and acute dialysis</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To evaluate the frequency of histological lesions and their prognosis (if kidney biopsy is performed)</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To evaluate the medico-economic impact of Eculizumab</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Objective of the first ancillary study: A first ancillary study will include a pangenomic analysis aimed at identifying new genetic variants associated with HE-aHUS. This ancillary study will be based on the residual genetic samples already scheduled in the biocollection. This ancillary study will be coordinated by Pr L. Mesnard (Nephrology Department, Tenon Hospital, Paris) and performed according to an already available funding</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Objective of any other potential ancillary study: biological collection For any other ancillary study: residual samples will be stored for a biological collection to identify new potential genetic and pathophysiological determinants of HE-aHUS (Department of Immunobiology, HEGP, Dr Frémeaux-Bacchi).</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Primary Endpoints</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type primary}">Primary</span></p><h3>OutcomeMeasures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Endpoint</b></td></tr><tr><td style="display: none">*</td><td>Response to therapy, defined by the absence of any of the following events: i) at 6-month follow-up: persistent renal replacement therapy, eGFR<15ml/mn/1,73m2, or patient death; ii) at W2 : persistent hemolysis despite well conducted antihypertensive therapy. Any Eculizumab rescue in the control group will be considered as a failure.</td><td><span title="Codes:{http://hl7.org/fhir/research-study-objective-type primary}">Primary</span></td><td><a href="EvidenceVariable-346487.html">CTIS2024-516402-32-00 Primary Outcome 1</a></td></tr></table></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Secondary Endpoints</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Prognosis role of repeat complement biomarkers (W1, W4, W13)</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p><p><b>endpoint</b>: <a href="EvidenceVariable-346488.html">CTIS2024-516402-32-00 Secondary Outcome 1</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Frequency of Complement genetic rare variants</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p><p><b>endpoint</b>: <a href="EvidenceVariable-346489.html">CTIS2024-516402-32-00 Secondary Outcome 2</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Renal replacement therapy rates at months 3 and 12 follow-up</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p><p><b>endpoint</b>: <a href="EvidenceVariable-346490.html">CTIS2024-516402-32-00 Secondary Outcome 3</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Frequency of severe infections (defined by the need for hospitalization)</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p><p><b>endpoint</b>: <a href="EvidenceVariable-346491.html">CTIS2024-516402-32-00 Secondary Outcome 4</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Time to resolution of haemolysis</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p><p><b>endpoint</b>: <a href="EvidenceVariable-346492.html">CTIS2024-516402-32-00 Secondary Outcome 5</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Time to resolution of renal replacement therapy</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p><p><b>endpoint</b>: <a href="EvidenceVariable-346493.html">CTIS2024-516402-32-00 Secondary Outcome 6</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Frequency and prognostic role of kidney lesions (glomerular and arteriolar microthromboses), glomerulosclerosis and kidney fibrosis if kidney biopsy is performed</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p><p><b>endpoint</b>: <a href="EvidenceVariable-346494.html">CTIS2024-516402-32-00 Secondary Outcome 7</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Costs relating to renal replacement therapy (or lack of), Eculizumab and other antihypertensive treatments, hospitalizations</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/research-study-objective-type secondary}">Secondary</span></p><p><b>endpoint</b>: <a href="EvidenceVariable-346495.html">CTIS2024-516402-32-00 Secondary Outcome 8</a></p></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #organization-554686</b></p><a name="346485/organization-554686"> </a><a name="hc346485/organization-554686"> </a><p><b>name</b>: Assistance Publique Hopitaux De Paris</p><p><b>description</b>: </p><div><p>Hospital/Clinic/Other health care facility</p>
</div></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: PractitionerRole #contact-190857</b></p><a name="346485/contact-190857"> </a><a name="hc346485/contact-190857"> </a><p><b>organization</b>: <a href="#hc346485/organization-554686">Assistance Publique Hopitaux De Paris</a></p><p><b>display</b>: Dr El Karoui Khalil khalil.el-karoui@aphp.fr</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Telecom</b></td></tr><tr><td style="display: none">*</td><td>Dr El Karoui Khalil</td><td><a href="mailto:khalil.el-karoui@aphp.fr">khalil.el-karoui@aphp.fr</a>, <a href="tel:+33156016317">+33156016317</a></td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: PractitionerRole #contact-190858</b></p><a name="346485/contact-190858"> </a><a name="hc346485/contact-190858"> </a><p><b>organization</b>: <a href="#hc346485/organization-554686">Assistance Publique Hopitaux De Paris</a></p><p><b>display</b>: Dr El Karoui Khalil khalil.el-karoui@aphp.fr</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Telecom</b></td></tr><tr><td style="display: none">*</td><td>Dr El Karoui Khalil</td><td><a href="mailto:khalil.el-karoui@aphp.fr">khalil.el-karoui@aphp.fr</a>, <a href="tel:+33156016317">+33156016317</a></td></tr></table></blockquote></div>
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<objective>
<name
value="To evaluate the role of complement biomarkers in predicting therapeutic response"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the frequency of complement genetic rare variants in this population"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the efficacy of early eculizumab administration added on standard of care BP control on 3-month (W13) and 12 months renal replacement therapy risk"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the frequency of severe infections in both groups"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the time to resolution of hemolysis and acute dialysis"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the frequency of histological lesions and their prognosis (if kidney biopsy is performed)"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name value="To evaluate the medico-economic impact of Eculizumab"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Objective of the first ancillary study: A first ancillary study will include a pangenomic analysis aimed at identifying new genetic variants associated with HE-aHUS. This ancillary study will be based on the residual genetic samples already scheduled in the biocollection. This ancillary study will be coordinated by Pr L. Mesnard (Nephrology Department, Tenon Hospital, Paris) and performed according to an already available funding"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Objective of any other potential ancillary study: biological collection For any other ancillary study: residual samples will be stored for a biological collection to identify new potential genetic and pathophysiological determinants of HE-aHUS (Department of Immunobiology, HEGP, Dr Frémeaux-Bacchi)."/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name value="Primary Endpoints"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
<outcomeMeasure>
<name
value="Response to therapy, defined by the absence of any of the following events: i) at 6-month follow-up: persistent renal replacement therapy, eGFR<15ml/mn/1,73m2, or patient death; ii) at W2 : persistent hemolysis despite well conducted antihypertensive therapy. Any Eculizumab rescue in the control group will be considered as a failure."/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
<endpoint>🔗
<reference value="EvidenceVariable/346487"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Primary Outcome 1"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Primary Outcome 1"/>
</endpoint>
</outcomeMeasure>
</objective>
<objective>
<name value="Secondary Endpoints"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<outcomeMeasure>
<name
value="Prognosis role of repeat complement biomarkers (W1, W4, W13)"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<endpoint>🔗
<reference value="EvidenceVariable/346488"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 1"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 1"/>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Frequency of Complement genetic rare variants"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<endpoint>🔗
<reference value="EvidenceVariable/346489"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 2"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 2"/>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="Renal replacement therapy rates at months 3 and 12 follow-up"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<endpoint>🔗
<reference value="EvidenceVariable/346490"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 3"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 3"/>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="Frequency of severe infections (defined by the need for hospitalization)"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<endpoint>🔗
<reference value="EvidenceVariable/346491"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 4"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 4"/>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Time to resolution of haemolysis"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<endpoint>🔗
<reference value="EvidenceVariable/346492"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 5"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 5"/>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Time to resolution of renal replacement therapy"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<endpoint>🔗
<reference value="EvidenceVariable/346493"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 6"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 6"/>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="Frequency and prognostic role of kidney lesions (glomerular and arteriolar microthromboses), glomerulosclerosis and kidney fibrosis if kidney biopsy is performed"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<endpoint>🔗
<reference value="EvidenceVariable/346494"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 7"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 7"/>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="Costs relating to renal replacement therapy (or lack of), Eculizumab and other antihypertensive treatments, hospitalizations"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<endpoint>🔗
<reference value="EvidenceVariable/346495"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 8"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 8"/>
</endpoint>
</outcomeMeasure>
</objective>
</ResearchStudy>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot3. Generated 2025-09-25
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