Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

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

: Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)

Page standards status: Informative

Raw json | Download

{
  "resourceType" : "EvidenceVariable",
  "id" : "367896",
  "meta" : {
    "versionId" : "31",
    "lastUpdated" : "2026-09-08T12:21:25.982Z",
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: EvidenceVariable 367896</b></p><a name=\"367896\"> </a><a name=\"hc367896\"> </a><div style=\"display: inline-block; background-color: #fbffeb; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 31; Last updated: 2026-09-08 12:21:25+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-variable-definition.html\">VariableDefinition</a></p></div><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=\"EvidenceVariable-367896.html\">EvidenceVariable Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)</a></p><p><b>identifier</b>: FEvIR Object Identifier/367896, FEvIR Linking Identifier/NCT03640312-otherOutcome-0, <a href=\"http://terminology.hl7.org/7.5.0/NamingSystem-uri.html\" title=\"As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt \r\n\r\nThis oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: \r\n\r\nNote that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.\r\n\r\nThis OID may also be used in CD.codeSystem.\">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.24.171</p><p><b>version</b>: 1.0.0-ballot3</p><p><b>name</b>: Percentage_of_Participants_With_Serious_Adverse_Events_SAEs_NCT03640312</p><p><b>title</b>: Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)</p><p><b>citeAs</b>: </p><div><p>Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312) [Database Entry: FHIR EvidenceVariable Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367896. Revised 2026-09-08. Available at: https://fevir.net/resources/EvidenceVariable/367896. Computable resource at: https://fevir.net/resources/EvidenceVariable/367896#json.</p>\n</div><p><b>status</b>: Active</p><p><b>date</b>: 2026-11-05 14:34:28+0000</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href=\"http://www.hl7.org/Special/committees/dss\">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: </p><div><p>Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.</p>\n</div><p><b>copyright</b>: </p><div><p>Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).</p>\n</div><h3>Definitions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Percentage of Participants With Serious Adverse Events (SAEs) Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.</span></td></tr></table><p><b>handling</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 evidence-variable-handling-not-specified}\">Evidence variable handling not specified</span></p><h3>Timings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Text</b></td></tr><tr><td style=\"display: none\">*</td><td>12 weeks</td></tr></table></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
      "valueCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
            "code" : "active",
            "display" : "Active"
          }
        ]
      }
    }
  ],
  "url" : "https://fevir.net/resources/EvidenceVariable/367896",
  "identifier" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code" : "ACSN",
            "display" : "Accession ID"
          }
        ],
        "text" : "FEvIR Object Identifier"
      },
      "system" : "https://fevir.net/FOI",
      "value" : "367896",
      "assigner" : {
        "display" : "Computable Publishing LLC"
      }
    },
    {
      "type" : {
        "text" : "FEvIR Linking Identifier"
      },
      "system" : "https://fevir.net/FLI",
      "value" : "NCT03640312-otherOutcome-0",
      "assigner" : {
        "display" : "Computable Publishing LLC"
      }
    },
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.44.24.171"
    }
  ],
  "version" : "1.0.0-ballot3",
  "name" : "Percentage_of_Participants_With_Serious_Adverse_Events_SAEs_NCT03640312",
  "title" : "Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)",
  "citeAs" : "Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312) [Database Entry: FHIR EvidenceVariable Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367896. Revised 2026-09-08. Available at: https://fevir.net/resources/EvidenceVariable/367896. Computable resource at: https://fevir.net/resources/EvidenceVariable/367896#json.",
  "status" : "active",
  "date" : "2026-11-05T14:34:28+00:00",
  "author" : [
    {
      "name" : "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
    }
  ],
  "publisher" : "HL7 International / Clinical Decision Support",
  "contact" : [
    {
      "name" : "HL7 International / Clinical Decision Support",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/dss"
        }
      ]
    }
  ],
  "description" : "Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.",
  "copyright" : "Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).",
  "definition" : {
    "concept" : {
      "text" : "Percentage of Participants With Serious Adverse Events (SAEs) Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above."
    }
  },
  "handling" : {
    "coding" : [
      {
        "system" : "https://fevir.net/resources/CodeSystem/179423",
        "code" : "evidence-variable-handling-not-specified",
        "display" : "Evidence variable handling not specified"
      }
    ]
  },
  "timing" : {
    "text" : "12 weeks"
  }
}