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Narrative

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Source1

{
  "resourceType": "Evidence",
  "id": "367927",
  "meta": {
    "versionId": "26",
    "lastUpdated": "2025-08-18T13:22:42.074Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
    ]
  },
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "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/Evidence/367927",
  "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": "367927",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "type": {
        "text": "FEvIR Linking Identifier"
      },
      "system": "https://fevir.net/FLI",
      "value": "NCT03640312-otherOutcomeMeasure-0--OG000",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "name": "NCT03640312_otherOutcomeMeasure_0_OG000",
  "title": "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312",
  "citeAs": "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367927. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367927. Computable resource at: https://fevir.net/resources/Evidence/367927#json.",
  "status": "active",
  "author": [
    {
      "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
    }
  ],
  "publisher": "Computable Publishing LLC",
  "contact": [
    {
      "telecom": [
        {
          "system": "email",
          "value": "support@computablepublishing.com"
        }
      ]
    }
  ],
  "copyright": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "description": "This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.",
  "variableDefinition": [
    {
      "description": "QUARTET LDQT",
      "note": [
        {
          "text": "Outcome Measure Population Description: All randomized participants"
        },
        {
          "text": "Outcome Measure Denominator Units: Participants"
        }
      ],
      "variableRole": "population",
      "observed": {
        "identifier": {
          "type": {
            "text": "ClinicalTrials.gov Outcome Measurement Group Id"
          },
          "value": "OG000"
        },
        "display": "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
      }
    },
    {
      "variableRole": "outcome",
      "observed": {
        "reference": "EvidenceVariable/367896",
        "type": "EvidenceVariable",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-otherOutcome-0",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        },
        "display": "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks -  (NCT03640312)"
      }
    }
  ],
  "statistic": [
    {
      "statisticType": {
        "coding": [
          {
            "system": "https://fevir.net/sevco",
            "code": "STATO:0000047",
            "display": "count"
          }
        ],
        "text": "Count of Participants"
      },
      "quantity": {
        "value": 2,
        "unit": "Participants"
      },
      "sampleSize": {
        "knownDataCount": 32
      },
      "attributeEstimate": [
        {
          "type": {
            "text": "Percentage"
          },
          "quantity": {
            "value": 6.25,
            "unit": "%"
          }
        }
      ]
    }
  ]
}