Clinical Study Schedule of Activities
1.0.0 - trial-use
Clinical Study Schedule of Activities
1.0.0 - trial-use
Clinical Study Schedule of Activities, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> .
@prefix mesh: <http://id.nlm.nih.gov/mesh/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix sct: <http://snomed.info/id/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:ResearchStudy ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "H2Q-MC-LZZT-ResearchStudy"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"H2Q-MC-LZZT-ResearchStudy\"> </a></p><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\">Resource ResearchStudy "H2Q-MC-LZZT-ResearchStudy" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ResearchStudySoa.html\">ResearchStudySoa</a></p></div><p><b>identifier</b>: id: H2Q-MC-LZZT (use: USUAL), id: NCTA12313212 (use: OFFICIAL), id: 60809</p><p><b>title</b>: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>protocol</b>: <a href=\"PlanDefinition-H2Q-MC-LZZT-ProtocolDesign.html\">PlanDefinition/H2Q-MC-LZZT-ProtocolDesign</a></p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: Treatment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-prim-purp-type.html\">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-phase.html\">ResearchStudyPhase</a>#phase-3)</span></p><p><b>category</b>: Interventional Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C98388)</span>, Randomized Clinical Trial <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C15417)</span>, Double Blind Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C15228)</span>, Placebo Control <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C49648)</span>, Parallel Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C82639)</span></p><p><b>focus</b>: Xanomeline <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C152926)</span>, Transdermal Patch Dosage Form <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C149996)</span>, PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>condition</b>: Alzheimer's Disease (Disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#26929004)</span></p><p><b>contact</b>: Bob James, Ph.D.: ph: 555-555-5555(WORK)</p><h3>RelatedArtifacts</h3><table class=\"grid\"><tr><td>-</td><td><b>Type</b></td><td><b>Label</b></td><td><b>Display</b></td><td><b>Citation</b></td><td><b>Url</b></td></tr><tr><td>*</td><td>documentation</td><td>Arch Neurol.1997;54(4):465-473</td><td>Arch Neurol.1997;54(4):465-473</td><td>Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022</td><td> </td></tr><tr><td>*</td><td>documentation</td><td>Protocol H2Q-MC-LZZT(c)</td><td> </td><td> </td><td><a href=\"https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf\">https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf</a></td></tr></table><p><b>keyword</b>: Selective M1 muscarinic agonists <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D018721)</span>, Alzheimer Disease <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D000544)</span>, Selective M1 muscarinic agonists <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D018721)</span></p><p><b>description</b>: ## Xanomeline (LY246708)\n### Protocol H2Q-MC-LZZT(c) \nSafety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>sponsor</b>: <a href=\"Organization-EliLillyAndCompany.html\">Organization/EliLillyAndCompany</a></p><p><b>principalInvestigator</b>: <a href=\"Practitioner-SamGetWell.html\">Practitioner/SamGetWell</a> " HOME"</p><p><b>reasonStopped</b>: Accrual Goal Met <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-reason-stopped.html\">ResearchStudyReasonStopped</a>#accrual-goal-met)</span></p><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo</p><p><b>type</b>: C49648 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C49648)</span></p><p><b>description</b>: Placebo arm</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Low-dose xanomeline arm</p><p><b>type</b>: C174266 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C174266)</span></p><p><b>description</b>: Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: High-dose xanomeline arm</p><p><b>type</b>: C174266 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C174266)</span></p><p><b>description</b>: High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)</p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To document the safety profile of the xanomeline TTS.</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the treatment response as a function of Apo E genotype.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote></div>"
] ; #
fhir:identifier ( [
fhir:use [ fhir:v "usual" ] ;
fhir:value [ fhir:v "H2Q-MC-LZZT" ]
] [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://clinicaltrials.gov/show/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCTA12313212" ]
] [
fhir:value [ fhir:v "60809" ]
] ) ; #
fhir:title [ fhir:v "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"] ; #
fhir:protocol ( [
fhir:reference [ fhir:v "PlanDefinition/H2Q-MC-LZZT-ProtocolDesign" ]
] ) ; #
fhir:status [ fhir:v "completed"] ; #
fhir:primaryPurposeType [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "treatment" ] ] )
] ; #
fhir:phase [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-phase"^^xsd:anyURI ] ;
fhir:code [ fhir:v "phase-3" ] ] )
] ; #
fhir:category ( [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C98388" ] ;
fhir:display [ fhir:v "Interventional Study" ] ] )
] [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C15417" ] ;
fhir:display [ fhir:v "Randomized Clinical Trial" ] ] )
] [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C15228" ] ;
fhir:display [ fhir:v "Double Blind Study" ] ] )
] [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C49648" ] ;
fhir:display [ fhir:v "Placebo Control" ] ] )
] [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C82639" ] ;
fhir:display [ fhir:v "Parallel Study" ] ] )
] ) ; #
fhir:focus ( [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C152926" ] ;
fhir:display [ fhir:v "Xanomeline" ] ] )
] [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C149996" ] ;
fhir:display [ fhir:v "Transdermal Patch Dosage Form" ] ] )
] [
fhir:text [ fhir:v "PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease" ]
] ) ; #
fhir:condition ( [
( fhir:coding [
a sct:26929004 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "26929004" ] ;
fhir:display [ fhir:v "Alzheimer's Disease (Disorder)" ] ] )
] ) ; #
fhir:contact ( [
fhir:name [ fhir:v "Bob James, Ph.D." ] ;
( fhir:telecom [
fhir:system [ fhir:v "phone" ] ;
fhir:value [ fhir:v "555-555-5555" ] ;
fhir:use [ fhir:v "work" ] ] )
] ) ; #
fhir:relatedArtifact ( [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "Arch Neurol.1997;54(4):465-473" ] ;
fhir:display [ fhir:v "Arch Neurol.1997;54(4):465-473" ] ;
fhir:citation [ fhir:v "Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022" ]
] [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "Protocol H2Q-MC-LZZT(c)" ] ;
fhir:url [ fhir:v "https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf"^^xsd:anyURI ]
] ) ; #
fhir:keyword ( [
( fhir:coding [
a mesh:D018721 ;
fhir:system [ fhir:v "https://www.nlm.nih.gov/mesh"^^xsd:anyURI ] ;
fhir:code [ fhir:v "D018721" ] ] ) ;
fhir:text [ fhir:v "Selective M1 muscarinic agonists" ]
] [
( fhir:coding [
a mesh:D000544 ;
fhir:system [ fhir:v "https://www.nlm.nih.gov/mesh"^^xsd:anyURI ] ;
fhir:code [ fhir:v "D000544" ] ] ) ;
fhir:text [ fhir:v "Alzheimer Disease" ]
] [
( fhir:coding [
a mesh:D018721 ;
fhir:system [ fhir:v "https://www.nlm.nih.gov/mesh"^^xsd:anyURI ] ;
fhir:code [ fhir:v "D018721" ] ] ) ;
fhir:text [ fhir:v "Selective M1 muscarinic agonists" ]
] ) ; #
fhir:description [ fhir:v "## Xanomeline (LY246708)\n### Protocol H2Q-MC-LZZT(c) \nSafety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"] ; #
fhir:sponsor [
fhir:reference [ fhir:v "Organization/EliLillyAndCompany" ]
] ; #
fhir:principalInvestigator [
fhir:reference [ fhir:v "Practitioner/SamGetWell" ]
] ; #
fhir:reasonStopped [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-reason-stopped"^^xsd:anyURI ] ;
fhir:code [ fhir:v "accrual-goal-met" ] ] )
] ; #
fhir:arm ( [
fhir:name [ fhir:v "Placebo" ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C49648" ] ] ) ] ;
fhir:description [ fhir:v "Placebo arm" ]
] [
fhir:name [ fhir:v "Low-dose xanomeline arm" ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C174266" ] ] ) ] ;
fhir:description [ fhir:v "Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)" ]
] [
fhir:name [ fhir:v "High-dose xanomeline arm" ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C174266" ] ] ) ] ;
fhir:description [ fhir:v "High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)" ]
] ) ; #
fhir:objective ( [
fhir:name [ fhir:v "To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg])." ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ] ) ]
] [
fhir:name [ fhir:v "To document the safety profile of the xanomeline TTS." ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ] ) ]
] [
fhir:name [ fhir:v "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas." ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ] ) ]
] [
fhir:name [ fhir:v "To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas." ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ] ) ]
] [
fhir:name [ fhir:v "To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment." ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ] ) ]
] [
fhir:name [ fhir:v "To assess the treatment response as a function of Apo E genotype." ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ] ) ]
] ) . #
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.vulcan-schedule#1.0.0 based on FHIR 4.0.1. Generated 2023-04-18
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