0.1.1 - ci-build
ScheduleOfActivityIG - Local Development build (v0.1.1). See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:ResearchStudy;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "H2Q-MC-LZZT-ResearchStudy"];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: H2Q-MC-LZZT (USUAL), id: NCTA12313212 (OFFICIAL), PLAC: NCTA12313212 (SECONDARY), PUBCHEM: 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\">Generated Summary: url: http://example.org/br-and-r/soa/PlanDefinition/H2Q-MC-LZZT-ProtocolDesign; version: 0.1.1; status: active; date: May 26, 2021, 2:52:13 PM</a></p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: <span title=\"Codes: \">treatment</span></p><p><b>phase</b>: <span title=\"Codes: \">phase-3</span></p><p><b>category</b>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C98388}\">Interventional Study</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C15417}\">Randomized Clinical Trial</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C15228}\">Double Blind Study</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C49648}\">Placebo Control</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C82639}\">Parallel Study</span></p><p><b>focus</b>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C152926}\">Xanomeline</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C149996}\">Transdermal Patch Dosage Form</span>, <span title=\"Codes: {https://pubmed.ncbi.nlm.nih.gov 9109749}\">Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease</span></p><p><b>condition</b>: <span title=\"Codes: \">Alzheimer's Disease (Disorder)</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></tr><tr><td>*</td></tr><tr><td>*</td></tr></table><p><b>keyword</b>: <span title=\"Codes: {https://id.nlm.nih.gov/mesh D018721}\">Selective M1 muscarinic agonists</span>, <span title=\"Codes: {https://id.nlm.nih.gov/mesh D000544}\">Alzheimer Disease</span>, <span title=\"Codes: {https://id.nlm.nih.gov/mesh D018721}\">Selective M1 muscarinic agonists</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>enrollment</b>: </p><ul><li><a href=\"Group-H2Q-MC-LZZT-ResearchStudy-Inclusion.html\">Generated Summary: type: person; </a></li><li><a href=\"Group-H2Q-MC-LZZT-ResearchStudy-Exclusion.html\">Generated Summary: type: person; </a></li></ul><p><b>sponsor</b>: <a href=\"Organization-EliLillyAndCompany.html\">Generated Summary: id: Eli Lilly and Company (OFFICIAL); <span title=\"Codes: \">crs</span></a></p><p><b>principalInvestigator</b>: <a href=\"Practitioner-SamGetWell.html\">Generated Summary: UPIN: ABC123 (OFFICIAL); active; Samuel Home ; Phone: 555-123-5467; gender: male</a></p><p><b>reasonStopped</b>: <span title=\"Codes: \">accrual-goal-met</span></p><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo</p><p><b>type</b>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C49648}\">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>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C174266}\">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>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C174266}\">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>: <span title=\"Codes: \">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>: <span title=\"Codes: \">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>: <span title=\"Codes: \">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>: <span title=\"Codes: \">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>: <span title=\"Codes: \">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>: <span title=\"Codes: \">secondary</span></p></blockquote></div>"
];
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fhir:ResearchStudy.title [ fhir:value "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"];
fhir:ResearchStudy.protocol [
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];
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fhir:Coding.display [ fhir:value "Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease" ] ]
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fhir:CodeableConcept.coding [
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fhir:Coding.code [ fhir:value "26929004" ];
fhir:Coding.display [ fhir:value "Alzheimer's Disease (Disorder)" ] ]
];
fhir:ResearchStudy.contact [
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fhir:ContactDetail.name [ fhir:value "Bob James, Ph.D." ];
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fhir:ContactPoint.use [ fhir:value "work" ] ]
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fhir:ResearchStudy.relatedArtifact [
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fhir:RelatedArtifact.type [ fhir:value "documentation" ];
fhir:RelatedArtifact.label [ fhir:value "Arch Neurol.1997;54(4):465-473" ];
fhir:RelatedArtifact.display [ fhir:value "Arch Neurol.1997;54(4):465-473" ];
fhir:RelatedArtifact.citation [ fhir:value "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" ]
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fhir:RelatedArtifact.url [ fhir:value "https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf" ]
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fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://id.nlm.nih.gov/mesh" ];
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fhir:Coding.system [ fhir:value "https://id.nlm.nih.gov/mesh" ];
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fhir:CodeableConcept.text [ fhir:value "Selective M1 muscarinic agonists" ]
];
fhir:ResearchStudy.description [ fhir:value "## 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:ResearchStudy.enrollment [
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fhir:Reference.reference [ fhir:value "Group/H2Q-MC-LZZT-ResearchStudy-Inclusion" ]
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fhir:Reference.reference [ fhir:value "Group/H2Q-MC-LZZT-ResearchStudy-Exclusion" ]
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fhir:ResearchStudy.sponsor [
fhir:Reference.reference [ fhir:value "Organization/EliLillyAndCompany" ]
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fhir:ResearchStudy.principalInvestigator [
fhir:Reference.reference [ fhir:value "Practitioner/SamGetWell" ]
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fhir:ResearchStudy.reasonStopped [
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fhir:index 0;
fhir:Coding.code [ fhir:value "accrual-goal-met" ] ]
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fhir:ResearchStudy.arm.description [ fhir:value "Placebo arm" ]
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fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
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fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
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fhir:ResearchStudy.arm.description [ fhir:value "High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)" ]
];
fhir:ResearchStudy.objective [
fhir:index 0;
fhir:ResearchStudy.objective.name [ fhir:value "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])." ];
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fhir:index 0;
fhir:Coding.code [ fhir:value "primary" ] ] ]
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fhir:ResearchStudy.objective.type [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.code [ fhir:value "primary" ] ] ]
], [
fhir:index 2;
fhir:ResearchStudy.objective.name [ fhir:value "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas." ];
fhir:ResearchStudy.objective.type [
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fhir:index 0;
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].
# - ontology header ------------------------------------------------------------
a owl:Ontology;
owl:imports fhir:fhir.ttl.