R6 Ballot (2nd Draft)
AdministrationPublish-box (todo)
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
Raw Turtle (+ also see Turtle/RDF Format Specification)
ClinicalTrials.gov Study Record
@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:id [ fhir:v "example-ctgov-study-record"] ; #
fhir:contained ( [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT05503693-drug------ap303-50-g" ] ;
fhir:name [ fhir:v "NCT05503693_drug______ap303_50_g" ] ;
fhir:title [ fhir:v "AP303 50 μg" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "AP303 tablet" ] ;
fhir:useContext ( [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for CT.gov" ]
] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]
]
] )
] [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT05503693-drug------ap303-150-g" ] ;
fhir:name [ fhir:v "NCT05503693_drug______ap303_150_g" ] ;
fhir:title [ fhir:v "AP303 150 μg" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "AP303 tablet" ] ;
fhir:useContext ( [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for CT.gov" ]
] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]
]
] )
] [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT05503693-drug------ap303-300-g" ] ;
fhir:name [ fhir:v "NCT05503693_drug______ap303_300_g" ] ;
fhir:title [ fhir:v "AP303 300 μg" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "AP303 tablet" ] ;
fhir:useContext ( [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for CT.gov" ]
] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]
]
] )
] [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT05503693-drug------ap303-600-g" ] ;
fhir:name [ fhir:v "NCT05503693_drug______ap303_600_g" ] ;
fhir:title [ fhir:v "AP303 600 μg" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "AP303 tablet" ] ;
fhir:useContext ( [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for CT.gov" ]
] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]
]
] )
] [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT05503693-drug------placebo-50-g" ] ;
fhir:name [ fhir:v "NCT05503693_drug______placebo_50_g" ] ;
fhir:title [ fhir:v "Placebo 50 μg" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "Placebo tablet" ] ;
fhir:useContext ( [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for CT.gov" ]
] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]
]
] )
] [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT05503693-drug------placebo-150-g" ] ;
fhir:name [ fhir:v "NCT05503693_drug______placebo_150_g" ] ;
fhir:title [ fhir:v "Placebo 150 μg" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "Placebo tablet" ] ;
fhir:useContext ( [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for CT.gov" ]
] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]
]
] )
] [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT05503693-drug------placebo-300-g" ] ;
fhir:name [ fhir:v "NCT05503693_drug______placebo_300_g" ] ;
fhir:title [ fhir:v "Placebo 300 μg" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "Placebo tablet" ] ;
fhir:useContext ( [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for CT.gov" ]
] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]
]
] )
] [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT05503693-drug------placebo-600-g" ] ;
fhir:name [ fhir:v "NCT05503693_drug______placebo_600_g" ] ;
fhir:title [ fhir:v "Placebo 600 μg" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "Placebo tablet" ] ;
fhir:useContext ( [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for CT.gov" ]
] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]
]
] )
] [
a fhir:Practitioner ;
fhir:id [ fhir:v "NCT05503693-CentralContact-0" ] ;
fhir:name ( [
fhir:text [ fhir:v "Zhen LIU" ]
] ) ;
fhir:telecom ( [
fhir:system [ fhir:v "phone" ] ;
fhir:value [ fhir:v "86 021-60836212" ]
] [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "clinicaloperation@alebund.com" ]
] )
] [
a fhir:ResearchStudy ;
fhir:id [ fhir:v "NCT05503693-Location-0-ResearchStudy" ] ;
fhir:partOf ( [
fhir:reference [ fhir:v "#" ] ;
fhir:type [ fhir:v "ResearchStudy"^^xsd:anyURI ]
] ) ;
fhir:status [ fhir:v "active" ] ;
fhir:site ( [
fhir:reference [ fhir:v "#NCT05503693-Location-0" ] ;
fhir:type [ fhir:v "Location"^^xsd:anyURI ]
] ) ;
fhir:progressStatus ( [
fhir:state [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "recruiting" ] ;
fhir:display [ fhir:v "Recruiting" ]
] )
]
] )
] [
a fhir:Location ;
fhir:id [ fhir:v "NCT05503693-Location-0" ] ;
fhir:name [ fhir:v "Nucleus Network Pty Ltd" ] ;
fhir:address [
fhir:city [ fhir:v "Melbourne" ] ;
fhir:state [ fhir:v "Victoria" ] ;
fhir:postalCode [ fhir:v "3004" ] ;
fhir:country [ fhir:v "Australia" ]
] ;
fhir:position [
fhir:longitude [ fhir:v "144.96332"^^xsd:decimal ] ;
fhir:latitude [ fhir:v "-37.814"^^xsd:decimal ]
]
] ) ; #
fhir:url [ fhir:v "https://fevir.net/resources/ResearchStudy/112103"^^xsd:anyURI] ; #
fhir:identifier ( [
fhir:type [
fhir:text [ fhir:v "FEvIR Object Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net"^^xsd:anyURI ] ;
fhir:value [ fhir:v "112103" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
] [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693" ]
] [
fhir:value [ fhir:v "AP303-PK-01" ] ;
fhir:assigner [
fhir:display [ fhir:v "Alebund Pharmaceuticals" ]
]
] ) ; #
fhir:name [ fhir:v "NCT05503693_FHIR_Transform"] ; #
fhir:title [ fhir:v "A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects"] ; #
fhir:label ( [
fhir:type [
fhir:text [ fhir:v "Official Title" ]
] ;
fhir:value [ fhir:v "A Single-center Randomized Double-blind Placebo-controlled Study to Investigate the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration and the Effect of Food on the PK of AP303 in Healthy Subjects" ]
] ) ; #
fhir:relatedArtifact ( [
fhir:type [ fhir:v "transforms" ] ;
fhir:document [
fhir:url [ fhir:v "https://beta.clinicaltrials.gov/api/v2/studies/NCT05503693"^^xsd:anyURI ]
]
] [
fhir:type [ fhir:v "transformed-with" ] ;
fhir:display [ fhir:v "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter" ] ;
fhir:document [
fhir:url [ fhir:v "https://fevir.net/resources/Project/29885"^^xsd:anyURI ]
]
] ) ; #
fhir:status [ fhir:v "active"] ; #
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:display [ 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-1" ] ;
fhir:display [ fhir:v "Phase 1" ]
] )
] ; #
fhir:studyDesign ( [
fhir:text [ fhir:v "Design Masking: Quadruple" ]
] [
fhir:text [ fhir:v "Design Who Masked: Participant" ]
] [
fhir:text [ fhir:v "Design Who Masked: Care Provider" ]
] [
fhir:text [ fhir:v "Design Who Masked: Investigator" ]
] [
fhir:text [ fhir:v "Design Who Masked: Outcomes Assessor" ]
] [
fhir:text [ fhir:v "Design Allocation: Randomized" ]
] [
fhir:text [ fhir:v "Design Intervention Model: Sequential Assignment" ]
] [
fhir:text [ fhir:v "CT.gov StudyType: INTERVENTIONAL" ]
] ) ; #
fhir:condition ( [
fhir:text [ fhir:v "Healthy Subjects" ]
] ) ; #
fhir:keyword ( [
fhir:text [ fhir:v "Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects" ]
] ) ; #
fhir:descriptionSummary [ fhir:v "This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects."] ; #
fhir:description [ fhir:v "The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food."] ; #
fhir:site ( [
fhir:reference [ fhir:v "#NCT05503693-Location-0-ResearchStudy" ] ;
fhir:type [ fhir:v "ResearchStudy"^^xsd:anyURI ]
] ) ; #
fhir:classifier ( [
fhir:text [ fhir:v "Has Results: False" ]
] [
fhir:text [ fhir:v "Oversight Classifier: oversightHasDmc Yes" ]
] [
fhir:text [ fhir:v "Oversight Classifier: isFdaRegulatedDrug No" ]
] [
fhir:text [ fhir:v "Oversight Classifier: isFdaRegulatedDevice No" ]
] ) ; #
fhir:associatedParty ( [
fhir:name [ fhir:v "Alebund Pharmaceuticals" ] ;
fhir:role [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-party-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "sponsor" ] ;
fhir:display [ fhir:v "Sponsor" ]
] )
] ;
fhir:classifier ( [
fhir:text [ fhir:v "INDUSTRY" ]
] )
] [
fhir:name [ fhir:v "Alebund Pty Ltd" ] ;
fhir:role [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-party-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "lead-sponsor" ] ;
fhir:display [ fhir:v "lead-sponsor" ]
] )
] ;
fhir:classifier ( [
fhir:text [ fhir:v "INDUSTRY" ]
] )
] [
fhir:name [ fhir:v "Zhen LIU" ] ;
fhir:role [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-party-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "recruitment-contact" ] ;
fhir:display [ fhir:v "recruitment-contact" ]
] )
] ;
fhir:classifier ( [
fhir:text [ fhir:v "Contact" ]
] ) ;
fhir:party [
fhir:reference [ fhir:v "#NCT05503693-CentralContact-0" ] ;
fhir:type [ fhir:v "Practitioner"^^xsd:anyURI ]
]
] [
fhir:name [ fhir:v "Sam Francis, Doctor" ] ;
fhir:role [
fhir:text [ fhir:v "Principal Investigator" ]
] ;
fhir:party [
fhir:display [ fhir:v "Nucleus Network" ]
]
] ) ; #
fhir:progressStatus ( [
fhir:state [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "recruiting" ] ;
fhir:display [ fhir:v "Recruiting" ]
] )
]
] [
fhir:state [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "overall-study" ] ;
fhir:display [ fhir:v "Overall Study" ]
] )
] ;
fhir:actual [ fhir:v "false"^^xsd:boolean ] ;
fhir:period [
fhir:start [ fhir:v "2022-12-06"^^xsd:date ] ;
fhir:end [ fhir:v "2023-06"^^xsd:gYearMonth ]
]
] ) ; #
fhir:recruitment [
fhir:targetNumber [ fhir:v "62"^^xsd:nonNegativeInteger ] ;
fhir:eligibility [
fhir:link <https://fevir.net/resources/EvidenceVariable/112075> ;
fhir:reference [ fhir:v "https://fevir.net/resources/EvidenceVariable/112075" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693 Eligibility Criteria" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] ; #
fhir:comparisonGroup ( [
fhir:linkId [ fhir:v "ap303" ] ;
fhir:name [ fhir:v "AP303" ] ;
fhir:type [
fhir:text [ fhir:v "Experimental" ]
] ;
fhir:description [ fhir:v "AP303" ] ;
fhir:intendedExposure ( [
fhir:reference [ fhir:v "#NCT05503693-drug------ap303-50-g" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: AP303 50 μg" ]
] [
fhir:reference [ fhir:v "#NCT05503693-drug------ap303-150-g" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: AP303 150 μg" ]
] [
fhir:reference [ fhir:v "#NCT05503693-drug------ap303-300-g" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: AP303 300 μg" ]
] [
fhir:reference [ fhir:v "#NCT05503693-drug------ap303-600-g" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: AP303 600 μg" ]
] )
] [
fhir:linkId [ fhir:v "placebo" ] ;
fhir:name [ fhir:v "Placebo" ] ;
fhir:type [
fhir:text [ fhir:v "Placebo Comparator" ]
] ;
fhir:description [ fhir:v "Placebo" ] ;
fhir:intendedExposure ( [
fhir:reference [ fhir:v "#NCT05503693-drug------placebo-50-g" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: Placebo 50 μg" ]
] [
fhir:reference [ fhir:v "#NCT05503693-drug------placebo-150-g" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: Placebo 150 μg" ]
] [
fhir:reference [ fhir:v "#NCT05503693-drug------placebo-300-g" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: Placebo 300 μg" ]
] [
fhir:reference [ fhir:v "#NCT05503693-drug------placebo-600-g" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: Placebo 600 μg" ]
] )
] ) ; #
fhir:outcomeMeasure ( [
fhir:name [ fhir:v "Single Dose and Food Effect Safety Outcome Measures" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-0" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Multiple Dose Safety Outcome Measures" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "Incidence and severity of AEs, laboratory, ECG, and vital sign changes." ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-1" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Cmax after single dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after single dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-2" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Tmax after single dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after single dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-3" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "AUC0-last after single dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after single dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-4" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "AUC0-inf after single dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after single dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-5" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "t1/2 after single dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after single dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-6" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "CL/F after single dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after single dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-7" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Ae and CLR (if warranted) after single dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after single dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-8" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "V/F after single dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after single dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-9" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Cmax after multiple dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after multiple dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-10" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Tmax after multiple dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after multiple dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-11" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "AUC0-τ after multiple dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after multiple dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-12" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Cav after multiple dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after multiple dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-13" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "t1/2 after multiple dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after multiple dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-14" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Rac after multiple dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after multiple dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-15" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Ae and CLR (if warranted) after multiple dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after multiple dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-16" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "V/F after multiple dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after multiple dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-17" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Ctrough after multiple dose" ] ;
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:display [ fhir:v "Primary" ]
] )
] ) ;
fhir:description [ fhir:v "PK characteristics after multiple dose" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-primaryOutcome-18" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Effect of Food on the single dose Cmax" ] ;
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:display [ fhir:v "Secondary" ]
] )
] ) ;
fhir:description [ fhir:v "Effect of food on the single dose PK" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-secondaryOutcome-0" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Effect of Food on the single dose Tmax" ] ;
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:display [ fhir:v "Secondary" ]
] )
] ) ;
fhir:description [ fhir:v "Effect of food on the single dose PK" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-secondaryOutcome-1" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Effect of Food on the single dose AUC0-last" ] ;
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:display [ fhir:v "Secondary" ]
] )
] ) ;
fhir:description [ fhir:v "Effect of food on the single dose PK" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-secondaryOutcome-2" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Effect of Food on the single dose AUC0-inf" ] ;
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:display [ fhir:v "Secondary" ]
] )
] ) ;
fhir:description [ fhir:v "Effect of food on the single dose PK" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-secondaryOutcome-3" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Effect of Food on the single dose t1/2" ] ;
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:display [ fhir:v "Secondary" ]
] )
] ) ;
fhir:description [ fhir:v "Effect of food on the single dose PK" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-secondaryOutcome-4" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Effect of Food on the single dose CL/F" ] ;
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:display [ fhir:v "Secondary" ]
] )
] ) ;
fhir:description [ fhir:v "Effect of food on the single dose PK" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-secondaryOutcome-5" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Effect of Food on the single dose Ae and CLR (if warranted)" ] ;
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:display [ fhir:v "Secondary" ]
] )
] ) ;
fhir:description [ fhir:v "Effect of food on the single dose PK" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-secondaryOutcome-6" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] [
fhir:name [ fhir:v "Effect of Food on the single dose V/F" ] ;
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:display [ fhir:v "Secondary" ]
] )
] ) ;
fhir:description [ fhir:v "Effect of food on the single dose PK" ] ;
fhir:reference [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]
] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT05503693-secondaryOutcome-7" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
]
]
] )] . #
# -------------------------------------------------------------------------------------
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot2 generated on Mon, Aug 12, 2024 16:59+0800.
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