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Packagehl7.fhir.uv.ebm
Resource TypeEvidence
IdEvidence-367948.json
FHIR VersionR6

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: Evidence 367948

version: 26; Last updated: 2025-08-18 13:22:42+0000; Language: en

Profile: ComparativeEvidence

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Evidence/367948

identifier: FEvIR Object Identifier/367948, FEvIR Linking Identifier/NCT03640312-secondaryOutcomeMeasure-6-OutcomeAnalysis-7-BetweenGroupAnalysis-OG000-OG001

name: NCT03640312_secondaryOutcomeMeasure_6_OutcomeAnalysis_7_BetweenGroupAnalysis_OG000_OG001

title: Medication Adherence at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

citeAs:

Medication Adherence at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan 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 367948. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367948. Computable resource at: https://fevir.net/resources/Evidence/367948#json.

status: Active

author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

copyright:

https://creativecommons.org/licenses/by-nc-sa/4.0/

description:

Logistic regression model adjusting for baseline systolic and diastolic blood pressure.

variableDefinition

note:

Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.

variableRole: Population

intended: Group NCT03640312 Eligibility Criteria

variableDefinition

description:

Group Assignment: QUARTET LDQT vs. Candesartan

variableRole: Exposure

comparatorCategory: Candesartan

observed: Group Assignment: 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. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.

variableDefinition

variableRole: Outcome

observed: Medication Adherence at 12 weeks (NCT03640312)

statistic

note:

Outcome Analysis NonInferiority Type: Superiority

statisticType: Odds Ratio (OR)

quantity: 0.64

attributeEstimate

type: P-value

quantity: 0.437

attributeEstimate

note:

CI Number of Sides: 2-Sided

type: Confidence interval

level: 0.95

range: 0.21-1.98

ModelCharacteristics

-Code
*Regression, Logistic

Source1

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  "id": "367948",
  "meta": {
    "versionId": "26",
    "lastUpdated": "2025-08-18T13:22:42.074Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"
    ]
  },
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
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  ],
  "url": "https://fevir.net/resources/Evidence/367948",
  "identifier": [
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      "type": {
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        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "367948",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "type": {
        "text": "FEvIR Linking Identifier"
      },
      "system": "https://fevir.net/FLI",
      "value": "NCT03640312-secondaryOutcomeMeasure-6-OutcomeAnalysis-7-BetweenGroupAnalysis-OG000-OG001",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "name": "NCT03640312_secondaryOutcomeMeasure_6_OutcomeAnalysis_7_BetweenGroupAnalysis_OG000_OG001",
  "title": "Medication Adherence at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312",
  "citeAs": "Medication Adherence at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan 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 367948. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367948. Computable resource at: https://fevir.net/resources/Evidence/367948#json.",
  "status": "active",
  "author": [
    {
      "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
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  "publisher": "Computable Publishing LLC",
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  "copyright": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "description": "Logistic regression model adjusting for baseline systolic and diastolic blood pressure.",
  "variableDefinition": [
    {
      "note": [
        {
          "text": "Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol."
        }
      ],
      "variableRole": "population",
      "intended": {
        "reference": "Group/367881",
        "type": "Group",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312 Eligibility Criteria",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      }
    },
    {
      "description": "Group Assignment: QUARTET LDQT vs. Candesartan",
      "variableRole": "exposure",
      "comparatorCategory": "Candesartan",
      "observed": {
        "display": "Group Assignment: 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. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
      }
    },
    {
      "variableRole": "outcome",
      "observed": {
        "reference": "EvidenceVariable/367889",
        "type": "EvidenceVariable",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-secondaryOutcome-6",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        },
        "display": "Medication Adherence at 12 weeks (NCT03640312)"
      }
    }
  ],
  "statistic": [
    {
      "note": [
        {
          "text": "Outcome Analysis NonInferiority Type: Superiority"
        }
      ],
      "statisticType": {
        "text": "Odds Ratio (OR)"
      },
      "quantity": {
        "value": 0.64
      },
      "attributeEstimate": [
        {
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
                "code": "C44185",
                "display": "P-value"
              }
            ]
          },
          "quantity": {
            "value": 0.437
          }
        },
        {
          "note": [
            {
              "text": "CI Number of Sides: 2-Sided"
            }
          ],
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
                "code": "C53324",
                "display": "Confidence interval"
              }
            ]
          },
          "level": 0.95,
          "range": {
            "low": {
              "value": 0.21
            },
            "high": {
              "value": 1.98
            }
          }
        }
      ],
      "modelCharacteristic": [
        {
          "code": {
            "text": "Regression, Logistic"
          }
        }
      ]
    }
  ]
}