Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - 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-ballot3 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" xml:lang="en" lang="en"><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: 10; Last updated: 2026-01-26 16:43:36+0000; Language: en</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>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/clinicalTrialId</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://terminology.hl7.org/CodeSystem/itle-type plain-language}">Plain language 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:">Protocol code</span></p><p><b>value</b>: APHP211039</p></blockquote><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/title-type primary}">Primary 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><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/itle-type plain-language}">Plain language 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 2026-01-26. 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/ctisconvert</p></blockquote><p><b>status</b>: Active</p><p><b>phase</b>: <span title="Codes:{https://fevir.net/sevco SEVCO:01035}">Therapeutic confirmatory (Phase III)</span></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>classifier</b>: <span title="Codes:">Trial Category 2</span>, <span title="Codes:">Justification for trial category assignment: Phase III</span>, <span title="Codes:">Trial scope Therapy</span>, <span title="Codes:">Trial scope Safety</span>, <span title="Codes:">Trial scope Efficacy</span>, <span title="Codes:{https://fevir.net/resources/CodeSystem/419455 includes-females}">Includes female subjects</span>, <span title="Codes:{https://fevir.net/resources/CodeSystem/419455 includes-males}">Includes male subjects</span>, <span title="Codes:{https://fevir.net/resources/CodeSystem/419455 includes-vulnerable-population}">Includes vulnerable populations</span></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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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><blockquote><p><b>progressStatus</b></p><p><b>state</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-status overall-study}">Overall study</span></p><p><b>actual</b>: false</p><p><b>period</b>: ?? --> 2027-02-13</p></blockquote><blockquote><p><b>progressStatus</b></p><p><b>state</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-status recruit}">Recruiting</span></p><p><b>actual</b>: false</p><p><b>period</b>: 2024-02-13 --> (ongoing)</p></blockquote><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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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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</party>
</associatedParty>
<associatedParty>
<name value="Dr El Karoui Khalil"/>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-party-role"/>
<code value="general-contact"/>
<display value="General contact"/>
</coding>
<text value="scientific contact"/>
</role>
<party>
<reference value="#contact-190858"/>
<type value="PractitionerRole"/>
<display value="Dr El Karoui Khalil khalil.el-karoui@aphp.fr"/>
</party>
</associatedParty>
<progressStatus>
<state>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-status"/>
<code value="overall-study"/>
<display value="Overall study"/>
</coding>
</state>
<actual value="false"/>
<period>
<end value="2027-02-13"/>
</period>
</progressStatus>
<progressStatus>
<state>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-status"/>
<code value="recruit"/>
<display value="Recruiting"/>
</coding>
</state>
<actual value="false"/>
<period>
<start value="2024-02-13"/>
</period>
</progressStatus>
<recruitment>
<eligibility>🔗
<reference value="Group/346486"/>
<type value="Group"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Eligibility Criteria"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Eligibility Criteria"/>
</eligibility>
</recruitment>
<objective>
<name
value="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."/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the role of complement biomarkers in predicting therapeutic response"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name value="Primary Endpoints"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/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-ballot3 based on FHIR 6.0.0-ballot3.
Generated
2026-02-10
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