Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot2: STU1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

: Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU) - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:ResearchStudy ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "346485"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "4" ] ;
fhir:lastUpdated [ fhir:v "2025-03-07T13:36:24.212Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/ctis-record"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/ctis-record>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"^^rdf:XMLLiteral
  ] ; # 
  fhir:contained ( [
a fhir:Organization ;
fhir:id [ fhir:v "organization-554686" ] ;
fhir:name [ fhir:v "Assistance Publique Hopitaux De Paris" ] ;
fhir:description [ fhir:v "Hospital/Clinic/Other health care facility" ]
  ] [
a fhir:PractitionerRole ;
fhir:id [ fhir:v "contact-190857" ] ;
fhir:organization [
fhir:reference [ fhir:v "#organization-554686" ] ;
fhir:type [ fhir:v "Organization"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Assistance Publique Hopitaux De Paris" ]     ] ;
fhir:display [ fhir:v "Dr El Karoui Khalil khalil.el-karoui@aphp.fr" ] ;
    ( fhir:contact [
      ( fhir:name [
fhir:text [ fhir:v "Dr El Karoui Khalil" ]       ] ) ;
      ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "khalil.el-karoui@aphp.fr" ]       ] [
fhir:system [ fhir:v "phone" ] ;
fhir:value [ fhir:v "+33156016317" ]       ] )     ] )
  ] [
a fhir:PractitionerRole ;
fhir:id [ fhir:v "contact-190858" ] ;
fhir:organization [
fhir:reference [ fhir:v "#organization-554686" ] ;
fhir:type [ fhir:v "Organization"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Assistance Publique Hopitaux De Paris" ]     ] ;
fhir:display [ fhir:v "Dr El Karoui Khalil khalil.el-karoui@aphp.fr" ] ;
    ( fhir:contact [
      ( fhir:name [
fhir:text [ fhir:v "Dr El Karoui Khalil" ]       ] ) ;
      ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "khalil.el-karoui@aphp.fr" ]       ] [
fhir:system [ fhir:v "phone" ] ;
fhir:value [ fhir:v "+33156016317" ]       ] )     ] )
  ] ) ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ] ;
fhir:value [
a fhir:ContactDetail ;
fhir:name [ fhir:v "Computable Publishing®: CTIS-to-FEvIR Converter" ]     ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "transforms"       ]     ] [
fhir:url [ fhir:v "targetUri"^^xsd:anyURI ] ;
fhir:value [
a fhir:uri ;
fhir:v "https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-516402-32-00"^^xsd:anyURI       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "transformed-with"       ]     ] [
fhir:url [ fhir:v "targetUri"^^xsd:anyURI ] ;
fhir:value [
a fhir:uri ;
fhir:v "https://fevir.net"^^xsd:anyURI       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to"^^xsd:anyURI ]
  ] ) ; # 
  fhir:url [ fhir:v "https://fevir.net/resources/ResearchStudy/346485"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ACSN" ] ;
fhir:display [ fhir:v "Accession ID" ]       ] ) ;
fhir:text [ fhir:v "FEvIR Object Identifier" ]     ] ;
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "https://fevir.net/FOI/346485" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://euclinicaltrials.eu/ctis"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2024-516402-32-00" ]
  ] ) ; # 
  fhir:name [ fhir:v "CTIS_2024_516402_32_00_FHIR_Transform"] ; # 
  fhir:title [ fhir:v "Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU)"] ; # 
  fhir:label ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ;
fhir:display [ fhir:v "Primary title" ]       ] ) ;
fhir:text [ fhir:v "Public title" ]     ] ;
fhir:value [ fhir:v "Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU)" ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "short-title" ] ;
fhir:display [ fhir:v "Short title" ]       ] )     ] ;
fhir:value [ fhir:v "APHP211039" ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "language" ] ;
fhir:display [ fhir:v "Different language" ]       ] ) ;
fhir:text [ fhir:v "French" ]     ] ;
fhir:value [ fhir:v "Eculizumab dans le syndrome hémolytique et urémique associé à l'urgence hypertensive: essai contrôlé multicentrique randomisé (HYPERSHU)" ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "language" ] ;
fhir:display [ fhir:v "Different language" ]       ] ) ;
fhir:text [ fhir:v "French of public title" ]     ] ;
fhir:value [ fhir:v "Eculizumab dans le syndrome hémolytique et urémique associé à l'urgence hypertensive: essai contrôlé multicentrique randomisé (HYPERSHU)" ]
  ] ) ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:condition ( [
fhir:text [ fhir:v "Adult patients with aHUS associated with HE and severe kidney involvement (needing dialysis or serum creatinine ≥ 354μM)" ]
  ] [
    ( fhir:coding [
fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ] ;
fhir:version [ fhir:v "20.1" ] ;
fhir:code [ fhir:v "10079840" ] ;
fhir:display [ fhir:v "Atypical haemolytic uraemic syndrome" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Example of CTISRecord Profile"] ; # 
  fhir:period [
fhir:start [ fhir:v "2024-02-13"^^xsd:date ] ;
fhir:end [ fhir:v "2027-02-13"^^xsd:date ]
  ] ; # 
  fhir:note ( [
fhir:text [ fhir:v "The target number for this trial (66) was not found in the EU CTIS record but it was found in the corresponding ClinicalTrials.gov record (NCT05726916)." ]
  ] ) ; # 
  fhir:associatedParty ( [
fhir:name [ fhir:v "Dr El Karoui Khalil" ] ;
fhir:role [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-party-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "general-contact" ] ;
fhir:display [ fhir:v "general-contact" ]       ] ) ;
fhir:text [ fhir:v "public contact" ]     ] ;
fhir:party [
fhir:reference [ fhir:v "#contact-190857" ] ;
fhir:type [ fhir:v "PractitionerRole"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Dr El Karoui Khalil khalil.el-karoui@aphp.fr" ]     ]
  ] [
fhir:name [ fhir:v "Dr El Karoui Khalil" ] ;
fhir:role [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-party-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "general-contact" ] ;
fhir:display [ fhir:v "general-contact" ]       ] ) ;
fhir:text [ fhir:v "scientific contact" ]     ] ;
fhir:party [
fhir:reference [ fhir:v "#contact-190858" ] ;
fhir:type [ fhir:v "PractitionerRole"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Dr El Karoui Khalil khalil.el-karoui@aphp.fr" ]     ]
  ] ) ; # 
  fhir:progressStatus ( [
fhir:state [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "overall-study" ] ;
fhir:display [ fhir:v "Overall study" ]       ] )     ] ;
fhir:actual [ fhir:v false ] ;
fhir:period [
fhir:start [ fhir:v "2024-02-13"^^xsd:date ] ;
fhir:end [ fhir:v "2027-02-13"^^xsd:date ]     ]
  ] ) ; # 
  fhir:recruitment [
fhir:targetNumber [ fhir:v "66"^^xsd:nonNegativeInteger ] ;
fhir:eligibility [
fhir:reference [ fhir:v "Group/346486" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]         ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Eligibility Criteria" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]         ]       ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Eligibility Criteria" ]     ]
  ] ; # 
  fhir:objective ( [
fhir:name [ fhir:v "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." ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ;
fhir:display [ fhir:v "Primary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "To evaluate the role of complement biomarkers in predicting therapeutic response" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "To evaluate the frequency of complement genetic rare variants in this population" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "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" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "To evaluate the frequency of severe infections in both groups" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "To evaluate the time to resolution of hemolysis and acute dialysis" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "To evaluate the frequency of histological lesions and their prognosis (if kidney biopsy is performed)" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "To evaluate the medico-economic impact of Eculizumab" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "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" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "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)." ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] [
    ( fhir:extension [
      ( fhir:extension [
fhir:url [ fhir:v "name"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "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."         ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ;
fhir:display [ fhir:v "Primary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "EvidenceVariable/346487" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Primary Outcome 1" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Primary Outcome 1" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"^^xsd:anyURI ]     ] ) ;
fhir:name [ fhir:v "Primary Endpoints" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ;
fhir:display [ fhir:v "Primary" ]       ] )     ]
  ] [
    ( fhir:extension [
      ( fhir:extension [
fhir:url [ fhir:v "name"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Prognosis role of repeat complement biomarkers (W1, W4, W13)"         ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "EvidenceVariable/346488" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 1" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 1" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "name"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Frequency of Complement genetic rare variants"         ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "EvidenceVariable/346489" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 2" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 2" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "name"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Renal replacement therapy rates at months 3 and 12 follow-up"         ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "EvidenceVariable/346490" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 3" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 3" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "name"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Frequency of severe infections (defined by the need for hospitalization)"         ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "EvidenceVariable/346491" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 4" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 4" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "name"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Time to resolution of haemolysis"         ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "EvidenceVariable/346492" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 5" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 5" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "name"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Time to resolution of renal replacement therapy"         ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "EvidenceVariable/346493" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 6" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 6" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "name"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Frequency and prognostic role of kidney lesions (glomerular and arteriolar microthromboses), glomerulosclerosis and kidney fibrosis if kidney biopsy is performed"         ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "EvidenceVariable/346494" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 7" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 7" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "name"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Costs relating to renal replacement therapy (or lack of), Eculizumab and other antihypertensive treatments, hospitalizations"         ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "EvidenceVariable/346495" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 8" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "CTIS2024-516402-32-00 Secondary Outcome 8" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"^^xsd:anyURI ]     ] ) ;
fhir:name [ fhir:v "Secondary Endpoints" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ]
  ] ) . #