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

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

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

Raw json | Download

{
  "resourceType" : "EvidenceVariable",
  "id" : "367896",
  "meta" : {
    "versionId" : "25",
    "lastUpdated" : "2025-08-15T10:32:26.138Z",
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
    ]
  },
  "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: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 25; Last updated: 2025-08-15 10:32:26+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-variable-definition.html\">VariableDefinition</a></p></div><p><b>EvidenceVariableHandlingDetail</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 evidence-variable-handling-not-specified}\">Evidence variable handling not specified</span></p><p><b>url</b>: <a href=\"https://fevir.net/resources/EvidenceVariable/367896\">https://fevir.net/resources/EvidenceVariable/367896</a></p><p><b>identifier</b>: FEvIR Object Identifier/367896, FEvIR Linking Identifier/NCT03640312-otherOutcome-0</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 2025-08-15. 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>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</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>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><h3>Definitions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#hc367896/variable-definition\">Group: membership = conceptual</a></td></tr></table><p><b>handling</b>: extension</p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Group #variable-definition</b></p><a name=\"367896/variable-definition\"> </a><a name=\"hc367896/variable-definition\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-conceptual-cohort-definition.html\">ConceptualCohortDefinition</a></p></div><p><b>membership</b>: Conceptual</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Percentage of Participants With Serious Adverse Events (SAEs)</span></p><p><b>exclude</b>: false</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></blockquote></blockquote></div>"
  },
  "contained" : [
    {
      "resourceType" : "Group",
      "id" : "variable-definition",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/conceptual-cohort-definition"
        ]
      },
      "membership" : "conceptual",
      "characteristic" : [
        {
          "code" : {
            "text" : "defined by CodeableConcept"
          },
          "valueCodeableConcept" : {
            "text" : "Percentage of Participants With Serious Adverse Events (SAEs)"
          },
          "exclude" : false,
          "timing" : [
            {
              "text" : "12 weeks"
            }
          ]
        }
      ]
    }
  ],
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
      "valueCodeableConcept" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "evidence-variable-handling-not-specified",
            "display" : "Evidence variable handling not specified"
          }
        ]
      }
    }
  ],
  "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"
      }
    }
  ],
  "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 2025-08-15. Available at: https://fevir.net/resources/EvidenceVariable/367896. Computable resource at: https://fevir.net/resources/EvidenceVariable/367896#json.",
  "status" : "active",
  "author" : [
    {
      "name" : "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
    }
  ],
  "publisher" : "Computable Publishing LLC",
  "contact" : [
    {
      "telecom" : [
        {
          "system" : "email",
          "value" : "support@computablepublishing.com"
        }
      ]
    }
  ],
  "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" : "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "definition" : {
    "reference" : {
      "reference" : "#variable-definition",
      "type" : "Group"
    }
  },
  "handling" : "extension"
}