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) at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

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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:2.16.840.1.113883.4.642.40.44.22.248</p><p><b>version</b>: 1.0.0-ballot3</p><p><b>name</b>: NCT03640312_otherOutcomeMeasure_0_OutcomeAnalysis_11_BetweenGroupAnalysis_OG000_OG001</p><p><b>title</b>: Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312</p><p><b>citeAs</b>: </p><div><p>Percentage of Participants With Serious Adverse Events (SAEs) 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 367952. Revised 2026-09-08. Available at: https://fevir.net/resources/Evidence/367952. Computable resource at: https://fevir.net/resources/Evidence/367952#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>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><p><b>description</b>: </p><div><p>This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>\n</div><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participants</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>intended</b>: <a href=\"Group-367881.html\">NCT03640312 Eligibility Criteria</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Group Assignment: QUARTET LDQT vs. Candesartan</p>\n</div><p><b>variableRole</b>: Exposure</p><p><b>comparatorCategory</b>: Candesartan</p><p><b>observed</b>: 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.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"EvidenceVariable-367896.html\">Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks (NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>note</b>: </p><blockquote><div><p>Outcome Analysis NonInferiority Type: Superiority</p>\n</div></blockquote><p><b>statisticType</b>: <span title=\"Codes:\">Risk Difference (RD)</span></p><p><b>quantity</b>: -0.06 Participants</p><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000037}\">standard error of the mean</span></p><p><b>quantity</b>: 0.04 Participants</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C44185}\">P-value</span></p><p><b>quantity</b>: 0.49</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>note</b>: </p><blockquote><div><p>CI Number of Sides: 2-Sided</p>\n</div></blockquote><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C53324}\">Confidence interval</span></p><p><b>level</b>: 0.95</p><p><b>range</b>: -0.15-0.02 Participants</p></blockquote><h3>ModelCharacteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Fisher Exact</span></td></tr></table></blockquote></div>"
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