Adverse Event Clinical Research
1.0.1 - STU1
Adverse Event Clinical Research
1.0.1 - STU1
Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. See the Directory of published versions
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{
"resourceType" : "ResearchStudy",
"id" : "BreastCancerTrial",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"BreastCancerTrial\"> </a><a name=\"hcBreastCancerTrial\"> </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 "BreastCancerTrial" </p></div><p><b>identifier</b>: <code>http://clinicaltrials.gov/</code>/NCT01234567</p><p><b>title</b>: Breast Cancer Clinical Trial bresentrik study</p><p><b>protocol</b>: <span>: This would reference the PlanDefinition which would contain references to Bresentrik</span></p><p><b>status</b>: active</p><p><b>primaryPurposeType</b>: Treatment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-research-study-prim-purp-type.html\">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 2/Phase 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-research-study-phase.html\">ResearchStudyPhase</a>#phase-2-phase-3)</span></p><p><b>studyDesign</b>: Interventional research <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-study-design.html\">Study Design</a>#SEVCO:01001)</span></p><p><b>condition</b>: Breast Cancer <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#254837009)</span></p><p><b>description</b>: Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer. The study aims to evaluate the efficacy, and safety of bresentrik, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if bresentrik allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.</p><p><b>period</b>: 2021-03-23 --> 2029-03-23</p><p><b>site</b>: <span>: This would be a reference to a Location containing the facility where the trial is taking place</span></p><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Iam Recruitment Contact</p><p><b>role</b>: recruitment-contact <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-research-study-party-role.html\">Research Study Party Role</a>#recruitment-contact)</span></p><p><b>classifier</b>: Contact <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>party</b>: <span>: This would be a reference which would provide phone number</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Alebund Pharmaceuticals</p><p><b>role</b>: sponsor <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-research-study-party-role.html\">Research Study Party Role</a>#sponsor)</span></p><p><b>classifier</b>: INDUSTRY <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>party</b>: <span>: This would be a reference Organization and would be the body legally responsible for the trial</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Alebund Pty Ltd</p><p><b>role</b>: lead-sponsor <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-research-study-party-role.html\">Research Study Party Role</a>#lead-sponsor)</span></p><p><b>classifier</b>: INDUSTRY <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>party</b>: <span>: This would be a reference Organization and would be the body legally responsible for the trial</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Sam Francis, Doctor</p><p><b>role</b>: Principal Investigator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-research-study-party-role.html\">Research Study Party Role</a>#primary-investigator "primary-investigator")</span></p><p><b>party</b>: <span>: This would be a reference to a Practitioner or PractionerRole</span></p></blockquote><h3>Recruitments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Eligibility</b></td></tr><tr><td style=\"display: none\">*</td><td><span>: This would be a reference to a Group, use Group.characteristic to define inclusion and exclusion criteria</span></td></tr></table><blockquote><p><b>comparisonGroup</b></p><p><b>name</b>: Arm A</p><p><b>type</b>: Experimental <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-research-study-arm-type.html\">ResearchStudy Arm Type Code System</a>#experimental)</span></p><p><b>description</b>: Bresentrik (B) plus pertuzumab-matching placebo</p></blockquote><blockquote><p><b>comparisonGroup</b></p><p><b>name</b>: Arm B</p><p><b>type</b>: Experimental <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-research-study-arm-type.html\">ResearchStudy Arm Type Code System</a>#experimental)</span></p><p><b>description</b>: Bresentrik (B) plus pertuzumab</p></blockquote><blockquote><p><b>comparisonGroup</b></p><p><b>name</b>: Arm C</p><p><b>type</b>: Active Comparator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-research-study-arm-type.html\">ResearchStudy Arm Type Code System</a>#active-comparator)</span></p><p><b>description</b>: Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)</p></blockquote></div>"
},
"identifier" : [
{
"system" : "http://clinicaltrials.gov/",
"value" : "NCT01234567",
"assigner" : {
"display" : "Allesgut Pharmaceuticals"
}
}
],
"title" : "Breast Cancer Clinical Trial bresentrik study",
"protocol" : [
{
"display" : "This would reference the PlanDefinition which would contain references to Bresentrik"
}
],
"status" : "active",
"primaryPurposeType" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
"code" : "treatment",
"display" : "Treatment"
}
]
},
"phase" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
"code" : "phase-2-phase-3"
}
]
},
"studyDesign" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/study-design",
"code" : "SEVCO:01001",
"display" : "Interventional research"
}
]
}
],
"condition" : [
{
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "254837009",
"display" : "Breast Cancer"
}
]
}
],
"description" : "Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer. The study aims to evaluate the efficacy, and safety of bresentrik, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if bresentrik allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.",
"period" : {
"start" : "2021-03-23",
"end" : "2029-03-23"
},
"site" : [
{
"display" : "This would be a reference to a Location containing the facility where the trial is taking place"
}
],
"associatedParty" : [
{
"name" : "Iam Recruitment Contact",
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-party-role",
"code" : "recruitment-contact",
"display" : "recruitment-contact"
}
]
},
"classifier" : [
{
"text" : "Contact"
}
],
"party" : {
"type" : "Practitioner",
"display" : "This would be a reference which would provide phone number"
}
},
{
"name" : "Alebund Pharmaceuticals",
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-party-role",
"code" : "sponsor",
"display" : "sponsor"
}
]
},
"classifier" : [
{
"text" : "INDUSTRY"
}
],
"party" : {
"display" : "This would be a reference Organization and would be the body legally responsible for the trial"
}
},
{
"name" : "Alebund Pty Ltd",
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-party-role",
"code" : "lead-sponsor",
"display" : "lead-sponsor"
}
]
},
"classifier" : [
{
"text" : "INDUSTRY"
}
],
"party" : {
"type" : "Practitioner",
"display" : "This would be a reference Organization and would be the body legally responsible for the trial"
}
},
{
"name" : "Sam Francis, Doctor",
"role" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-party-role",
"code" : "primary-investigator",
"display" : "primary-investigator"
}
],
"text" : "Principal Investigator"
},
"party" : {
"display" : "This would be a reference to a Practitioner or PractionerRole"
}
}
],
"recruitment" : {
"eligibility" : {
"display" : "This would be a reference to a Group, use Group.characteristic to define inclusion and exclusion criteria"
}
},
"comparisonGroup" : [
{
"name" : "Arm A",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-arm-type",
"code" : "experimental",
"display" : "Experimental"
}
]
},
"description" : "Bresentrik (B) plus pertuzumab-matching placebo"
},
{
"name" : "Arm B",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-arm-type",
"code" : "experimental",
"display" : "Experimental"
}
]
},
"description" : "Bresentrik (B) plus pertuzumab"
},
{
"name" : "Arm C",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-arm-type",
"code" : "active-comparator",
"display" : "Active Comparator"
}
]
},
"description" : "Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)"
}
]
}
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.ae-research-ig#1.0.1 based on FHIR 5.0.0. Generated 2024-04-30
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