openapi: 3.0.0 info: title: CDISC Analysis Results Standard (ARS) description: REST API documentation for ARS version: '0.1' contact: name: CDISC Library Support email: cdisc_library_support@cdisc.org license: name: License for CDISC Members & Open Source Developers url: https://www.cdisc.org/cdisc-library/api-account-request externalDocs: description: Media Type Support Matrix url: https://wiki.cdisc.org/display/LIBSUPRT/Media+Type+Support+Matrix servers: - description: SwaggerHub API Auto Mocking url: https://virtserver.swaggerhub.com/CDISC1/cdisc-library/1.5 - description: Production CDISC Libray url: https://library.cdisc.org/api security: - ApiKeyAuth: [] paths: ################################################################################ # Analysis Results Standard Paths /mdr/ars/packages: get: operationId: api.products.ars.get_packages description: Get a list of available ARS packages. tags: - Analysis Results Standards (ARS) responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsPackages' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents: get: operationId: api.products.ars.get_package_reportingevents description: Get a list of reporting events in an ARS package. tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsReportingEvents' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}: get: operationId: api.products.ars.get_package_reportingevent description: Get the contents of a reporting event. tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsReportingEvent' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/analysissets/{analysisset}: get: operationId: api.products.ars.get_package_reportingevent_analysisset description: Get the details of an analysis set for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsAnalysisSet' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsAnalysisSet' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/datasubsets/{datasubset}: get: operationId: api.products.ars.get_package_reportingevent_datasubset description: Get the details of a data subset for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsDataSubset' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsDataSubset' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/analysisgroupings/{analysisgrouping}: get: operationId: api.products.ars.get_package_reportingevent_analysisgrouping description: Get the details of an analysis grouping for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsSubjectGroupingFactor' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsSubjectGroupingFactor' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/analysisgroupings/{analysisgrouping}/analysisgroups/{analysisgroup}: get: operationId: api.products.ars.get_package_reportingevent_analysisgrouping_analysisgrou description: Get the details of an analysis grouping for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsSubjectGroupingFactor' - $ref: '#/components/parameters/arsAnalysisGroup' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsAnalysisGroup' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/methods/{method}: get: operationId: api.products.ars.get_package_reportingevent_method description: Get the details of a method for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsAnalysisMethod' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsAnalysisMethod' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/methods/{method}/operations/{operation}: get: operationId: api.products.ars.get_package_reportingevent_method_operation description: Get the details of a method operation for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsAnalysisMethod' - $ref: '#/components/parameters/arsOperation' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsOperation' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/methods/{method}/operations/{operation}/refoprels/{refoprel}: get: operationId: api.products.ars.get_package_reportingevent_method_operation_refoprel description: Get the details of a referenced operation relationship for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsAnalysisMethod' - $ref: '#/components/parameters/arsOperation' - $ref: '#/components/parameters/arsReferencedOperationRelationship' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsReferencedOperationRelationship' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/analyses/{analysis}: get: operationId: api.products.ars.get_package_reportingevent_analysis description: Get the details of an analysis for a reporting event, optionally including results tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsAnalysis' - $ref: '#/components/parameters/arsIncludeResults' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsAnalysis' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/analyses/{analysis}/datagroupings/{datagrouping}: get: operationId: api.products.ars.get_package_reportingevent_analysis_datagrouping description: Get the details of a data grouping for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsAnalysis' - $ref: '#/components/parameters/arsDataGrouping' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsDataGroupingFactor' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/analyses/{analysis}/datagroupings/{datagrouping}/datagroups/{datagroup}: get: operationId: api.products.ars.get_package_reportingevent_analysis_datagrouping_datagroup description: Get the details of a data grouping for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsAnalysis' - $ref: '#/components/parameters/arsDataGrouping' - $ref: '#/components/parameters/arsDataGroup' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsDataGroup' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/outputs/{output}: get: operationId: api.products.ars.get_package_reportingevent_output description: Get the details of an output for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsOutput' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsOutput' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/outputs/{output}/displays/{display}: get: operationId: api.products.ars.get_package_reportingevent_output_display description: Get the details of a displayfor a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsOutput' - $ref: '#/components/parameters/arsDisplay' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsDisplay' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/categorizations/{categorization}: get: operationId: api.products.ars.get_package_reportingevent_categorization description: Get the details of a categorization for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsAnalysisCategorization' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsAnalysisCategorization' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' /mdr/ars/packages/{package}/reportingevents/{reportingevent}/categorizations/{categorization}/categories/{category}: get: operationId: api.products.ars.get_package_reportingevent_categorization_category description: Get the details of a category for a reporting event tags: - Analysis Results Standards (ARS) parameters: - $ref: '#/components/parameters/arsPackage' - $ref: '#/components/parameters/arsReportingEvent' - $ref: '#/components/parameters/arsAnalysisCategorization' - $ref: '#/components/parameters/arsAnalysisCategory' responses: '200': description: OK content: application/json: schema: $ref: '#/components/schemas/arsAnalysisCategory' '400': $ref: '#/components/responses/statusBadRequest' '401': $ref: '#/components/responses/statusUnauthorized' '403': $ref: '#/components/responses/statusForbidden' '404': $ref: '#/components/responses/statusNotFound' '405': $ref: '#/components/responses/statusNotAllowed' '406': $ref: '#/components/responses/statusNotAcceptable' '500': $ref: '#/components/responses/statusInternalError' '503': $ref: '#/components/responses/statusServiceUnavailable' '504': $ref: '#/components/responses/statusGatewayTimeout' ################################################################################ components: securitySchemes: ApiKeyAuth: type: apiKey in: header name: api-key parameters: # Analysis Results Standard Parameters arsPackage: in: path name: package required: true description: Analysis Results Standard Package Identifier schema: type: string example: 2023-10-26 arsReportingEvent: in: path name: reportingevent required: true description: Reporting Event Identifier schema: type: string example: ARS-CSD-v1 arsAnalysisSet: in: path name: analysisset required: true description: Analysis Set Identifier schema: type: string example: AnalysisSet_01_ITT arsDataSubset: in: path name: datasubset required: true description: Data Subset Identifier schema: type: string example: Dss01_TEAE arsSubjectGroupingFactor: in: path name: analysisgrouping required: true description: Analysis Grouping Identifier schema: type: string example: AnlsGrouping_02_Trt arsAnalysisGroup: in: path name: analysisgroup required: true description: Analysis Group Identifier schema: type: string example: AnlsGrouping_02_Trt_1 arsAnalysisMethod: in: path name: method required: true description: Analysis Method Identifier schema: type: string example: Mth01_CatVar_ByGrp arsOperation: in: path name: operation required: true description: Analysis Method Operation Identifier schema: type: string example: Mth01_CatVar_ByGrp_1_n arsReferencedOperationRelationship: in: path name: refoprel required: true description: Referenced Operation Relationship Identifier schema: type: string example: Mth01_CatVar_ByGrp_2_pct_NUM arsAnalysis: in: path name: analysis required: true description: Analysis Identifier schema: type: string example: An01.05_SAF_ByTrt arsDataGrouping: in: path name: datagrouping required: true description: Data Grouping Identifier schema: type: string example: AnlsGrouping_06_Soc arsDataGroup: in: path name: datagroup required: true description: Data Group Identifier schema: type: string example: AnlsGrouping_09_Visit_01 arsOutput: in: path name: output required: true description: Output Identifier schema: type: string example: Out14.1.1 arsDisplay: in: path name: display required: true description: Display Identifier schema: type: string example: Out14.1.1 arsAnalysisCategorization: in: path name: categorization required: true description: Categorization Identifier schema: type: string example: AnCat1_Group arsAnalysisCategory: in: path name: category required: true description: Category Identifier schema: type: string example: AnCat1_Group_Safety arsIncludeResults: in: query name: includeresults description: Include Analysis Results schema: type: boolean example: false # Responses responses: statusBadRequest: description: Bad Request content: application/json: schema: $ref: '#/components/schemas/defaultErrorResponse' statusForbidden: description: Forbidden content: application/json: schema: $ref: '#/components/schemas/defaultErrorResponse' statusUnauthorized: description: Unauthorized headers: WWW_Authenticate: schema: type: string content: application/json: schema: $ref: '#/components/schemas/defaultErrorResponse' statusNotFound: description: Not Found content: application/json: schema: $ref: '#/components/schemas/defaultErrorResponse' statusNotAllowed: description: Method Not Allowed content: application/json: schema: $ref: '#/components/schemas/defaultErrorResponse' statusNotAcceptable: description: Not Acceptable content: application/json: schema: $ref: '#/components/schemas/defaultErrorResponse' statusInternalError: description: Internal Server Error content: application/json: schema: $ref: '#/components/schemas/defaultErrorResponse' statusServiceUnavailable: description: Service Unavailable content: application/json: schema: $ref: '#/components/schemas/defaultErrorResponse' statusGatewayTimeout: description: Gateway Timeout Error content: application/json: schema: $ref: '#/components/schemas/defaultErrorResponse' # Schemas schemas: defaultErrorResponse: properties: statusCode: description: HTTP Status Code type: string detail: description: Detail type: string message: description: Message type: string ################################################################################ # Analysis Results Standard Packages arsPackages: type: object properties: _links: $ref: '#/components/schemas/arsPackagesLinks' arsPackagesLinks: type: object properties: self: $ref: '#/components/schemas/arsPackagesRef' packages: type: array items: $ref: '#/components/schemas/arsPackageRef' arsPackagesRef: type: object properties: href: type: string example: /mdr/ars/packages title: type: string example: Product Group Analysis Results Standards type: type: string example: Analysis Results Standard Package List arsPackageRef: type: object properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents title: type: string example: Analysis Results Standard Package Effective 2023-10-26 type: type: string example: Analysis Results Standard Package # Analysis Results Standards by Package arsReportingEvents: type: object properties: name: type: string example: Analysis Results Standards 2023-10-26 label: type: string example: Analysis Results Standard Package Effective 2023-10-26 effectiveDate: type: string example: '2023-10-26' version: type: string example: '2023-10-26' _links: $ref: '#/components/schemas/arsReportingEventsLinks' arsReportingEventsLinks: type: object properties: self: $ref: '#/components/schemas/arsReportingEventsRef' reportingEvents: type: array items: $ref: '#/components/schemas/arsReportingEventRef' arsReportingEventsRef: type: object description: Analysis Results Standards Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents title: type: string example: Analysis Results Standards type: type: string example: Analysis Results Standard List arsReportingEventRef: type: object description: Analysis Results Standard Reporting Event Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1 title: type: string example: Common Safety Displays Version 1 type: type: string example: Analysis Results Standard Example Reporting Event # Analysis Results Standard by Package arsReportingEvent: type: object properties: id: type: string example: ARS-CSD-v1 name: type: string example: Common Safety Displays Version 1 description: type: string example: An example reporting event containing a set of common safety displays listOfPlannedAnalyses: $ref: '#/components/schemas/arsListOfPlannedAnalyses' listOfPlannedOutputs: $ref: '#/components/schemas/arsListOfPlannedOutputs' analysisSets: type: array items: $ref: '#/components/schemas/arsAnalysisSetRef' analysisGroupings: type: array items: $ref: '#/components/schemas/arsSubjectGroupingFactorRef' dataSubsets: type: array items: $ref: '#/components/schemas/arsDataSubsetRef' methods: type: array items: $ref: '#/components/schemas/arsAnalysisMethodRef' analyses: type: array items: $ref: '#/components/schemas/arsAnalysisRef' outputs: type: array items: $ref: '#/components/schemas/arsOutputRef' analysisCategorizations: type: array items: $ref: '#/components/schemas/arsAnalysisCategorizationRef' _links: $ref: '#/components/schemas/arsReportingEventLinks' required: - id - name - listOfPlannedAnalyses arsNestedList: type: object properties: listItems: type: array items: $ref: '#/components/schemas/arsOrderedListItem' arsOrderedListItem: type: object properties: name: type: string example: Summary of Demographics level: type: integer example: 1 order: type: integer example: 1 sublist: $ref: '#/components/schemas/arsNestedList' analysis: $ref: '#/components/schemas/arsAnalysisRef' output: $ref: '#/components/schemas/arsOutputRef' required: - name - level - order arsListOfPlannedAnalyses: allOf: - type: object description: Analysis Results Standard List of Planned Analyses - $ref: '#/components/schemas/arsNestedList' arsListOfPlannedOutputs: allOf: - type: object description: Analysis Results Standard List of Planned Outputs - $ref: '#/components/schemas/arsNestedList' arsReportingEventLinks: type: object properties: self: $ref: '#/components/schemas/arsReportingEventRef' parentPackage: $ref: '#/components/schemas/arsPackageRef' arsAnalysisSetRef: type: object description: Analysis Results Standard Analysis Set Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/analysissets/AnalysisSet_01_ITT title: type: string example: Intent-to-Treat Population type: type: string example: Analysis Results Standards Analysis Set arsSubjectGroupingFactorRef: type: object description: Analysis Results Standard Subject Grouping Factor Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/analysisgroupings/AnlsGrouping_02_Trt title: type: string example: Treatment type: type: string example: Analysis Results Standards Analysis Grouping arsDataSubsetRef: type: object description: Analysis Results Standard Data Subset Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/datasubsets/Dss01_TEAE title: type: string example: Treatment-Emergent Adverse Events type: type: string example: Analysis Results Standards Data Subset arsAnalysisMethodRef: type: object description: Analysis Results Standard Analysis Method Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/methods/Mth01_CatVar_ByGrp title: type: string example: Summary by group of a categorical variable type: type: string example: Analysis Results Standards Analysis Method arsAnalysisRef: type: object description: Analysis Results Standard Analysis Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/analyses/An01.05_SAF_ByTrt title: type: string example: Summary of Subjects by Treatment type: type: string example: Analysis Results Standards Analysis arsOutputRef: type: object description: Analysis Results Standard Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/outputs/Out14.1.1 title: type: string example: Summary of Demographics type: type: string example: Analysis Results Standards Output arsAnalysisCategorizationRef: type: object description: Analysis Results Standard Categorization Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/categorizations/AnCat1_Group title: type: string example: Group of Analyses type: type: string example: Analysis Results Standards Categorization arsWhereClause: type: object description: Analysis Results Standard Where Clause properties: level: type: integer order: type: integer condition: $ref: '#/components/schemas/arsCondition' compoundExpression: $ref: '#/components/schemas/arsCompoundExpression' arsCondition: type: object description: Analysis Results Standard Condition properties: dataset: type: string variable: type: string comparator: type: string enum: - EQ - NE - GT - GE - LT - LE - IN - NOTIN value: type: array items: type: string arsCompoundExpression: type: object description: Analysis Results Standard Compound Expression properties: logicalOperator: type: string enum: - AND - OR - NOT whereClauses: type: array items: $ref: '#/components/schemas/arsWhereClause' arsAnalysisSetLinks: type: object properties: self: $ref: '#/components/schemas/arsAnalysisSetRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsAnalysisSet: allOf: - type: object description: Analysis Results Standard Analysis Set properties: id: type: string name: type: string required: - id - name - $ref: '#/components/schemas/arsWhereClause' - type: object properties: _links: $ref: '#/components/schemas/arsAnalysisSetLinks' arsSubjectGroupingFactorLinks: type: object properties: self: $ref: '#/components/schemas/arsSubjectGroupingFactorRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsSubjectGroupingFactor: type: object description: Analysis Results Standard Subject Grouping Factor properties: id: type: string example: AnlsGrouping_01_Sex label: type: string example: Gender groupingVariable: type: string example: SEX dataDriven: type: boolean example: false groupings: type: array items: $ref: '#/components/schemas/arsAnalysisGroupRef' _links: $ref: '#/components/schemas/arsSubjectGroupingFactorLinks' arsAnalysisGroupRef: type: object description: Analysis Results Standard Analysis Group Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/analysisgroupings/AnlsGrouping_02_Trt/analysisgroups/AnlsGrouping_02_Trt_1 title: type: string example: Placebo type: type: string example: Analysis Results Standards Analysis Group arsAnalysisGroupLinks: type: object properties: self: $ref: '#/components/schemas/arsAnalysisGroupRef' parentAnalysisGroupingFactor: $ref: '#/components/schemas/arsAnalysisRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsAnalysisGroup: allOf: - type: object description: Analysis Results Standard Analysis Group properties: id: type: string name: type: string required: - id - name - $ref: '#/components/schemas/arsWhereClause' - type: object properties: _links: $ref: '#/components/schemas/arsAnalysisGroupLinks' arsDataGroupingFactorRef: type: object description: Analysis Results Standard Data Grouping Factor Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/analyses/An07.09_Soc_ByTrt/datagroupings/AnlsGrouping_06_Soc title: type: string example: Treatment type: type: string example: Analysis Results Standards Data Grouping Factor arsDataGroupingFactorLinks: type: object properties: self: $ref: '#/components/schemas/arsDataGroupingFactorRef' parentAnalysis: $ref: '#/components/schemas/arsAnalysisRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsDataGroupingFactor: type: object description: Analysis Results Standard Data Grouping Factor properties: id: type: string example: AnlsGrouping_06_Soc label: type: string example: System Organ Class groupingVariable: type: string example: AESOC dataDriven: type: boolean example: true groupings: type: array items: $ref: '#/components/schemas/arsDataGroupRef' example: _links: $ref: '#/components/schemas/arsDataGroupingFactorLinks' arsDataGroupRef: type: object description: Analysis Results Standard Data Group Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/analyses/An07.09_Soc_ByTrt/datagroupings/AnlsGrouping_09_Visit/datagroups/AnlsGrouping_09_Visit_01 title: type: string example: Baseline type: type: string example: Analysis Results Standards Data Group arsDataGroupLinks: type: object properties: self: $ref: '#/components/schemas/arsDataGroupRef' parentDataGroupingFactor: $ref: '#/components/schemas/arsAnalysisRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsDataGroup: allOf: - type: object description: Analysis Results Standard Analysis Group properties: id: type: string name: type: string required: - id - name - $ref: '#/components/schemas/arsWhereClause' - type: object properties: _links: $ref: '#/components/schemas/arsDataGroupLinks' arsDataSubsetLinks: type: object properties: self: $ref: '#/components/schemas/arsDataSubsetRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsDataSubset: allOf: - type: object description: Analysis Results Standard Data Subset properties: id: type: string name: type: string required: - id - name - $ref: '#/components/schemas/arsWhereClause' - type: object properties: _links: $ref: '#/components/schemas/arsDataSubsetLinks' arsAnalysisMethodLinks: type: object properties: self: $ref: '#/components/schemas/arsAnalysisMethodRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsAnalysisMethod: type: object description: Analysis Results Standard Analysis Method properties: id: type: string example: Mth01_CatVar_ByGrp name: type: string example: Summary by group of a categorical variable label: type: string example: Grouped summary of categorical variable description: type: string example: Descriptive summary statistics across groups for a categorical variable, based on subject occurrence operations: type: array items: $ref: '#/components/schemas/arsOperationRef' _links: $ref: '#/components/schemas/arsAnalysisMethodLinks' arsOperationRef: type: object description: Analysis Results Standard Analysis Method Operation Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/methods/Mth01_CatVar_ByGrp/operations/Mth01_CatVar_ByGrp_1_n title: type: string example: Count of subjects type: type: string example: Analysis Results Standards Analysis Method Operation arsOperationLinks: type: object properties: self: $ref: '#/components/schemas/arsOperationRef' parentMethod: $ref: '#/components/schemas/arsAnalysisMethodRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsOperation: type: object description: Analysis Results Standard Analysis Method Operation properties: id: type: string example: Mth01_CatVar_ByGrp_2_pct name: type: string example: Percent of subjects label: type: string example: '%' referencedOperationRelationships: type: array items: $ref: '#/components/schemas/arsReferencedOperationRelationshipRef' resultPattern: type: string example: ( XX.X) _links: $ref: '#/components/schemas/arsOperationLinks' arsReferencedOperationRelationshipRef: type: object description: Analysis Results Standard Referenced Operation Relationship Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/methods/Mth01_CatVar_ByGrp/operations/Mth01_CatVar_ByGrp_1_n/refoprels/Mth01_CatVar_ByGrp_2_pct_NUM title: type: string example: Percent of subjects Numerator type: type: string example: Analysis Results Standards Referenced Operation Relationship arsReferencedOperationRelationshipLinks: type: object properties: self: $ref: '#/components/schemas/arsReferencedOperationRelationshipRef' parentOperation: $ref: '#/components/schemas/arsOperationRef' parentMethod: $ref: '#/components/schemas/arsAnalysisMethodRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsReferencedOperationRelationship: type: object description: Analysis Results Standard Referenced Operation Relationship properties: id: type: string example: Mth01_CatVar_ByGrp_2_pct_NUM referencedOperationRole: type: string enum: - NUMERATOR - DEMONIATOR operation: $ref: '#/components/schemas/arsOperationRef' analysis: $ref: '#/components/schemas/arsAnalysisRef' description: type: string example: The count operation whose result provides the numerator for calculation of the percentage. The referenced analysis should be the analysis that contains this percent operation. _links: $ref: '#/components/schemas/arsReferencedOperationRelationshipLinks' required: - id - referencedOperationRole - operation arsOrderedGrouping: type: object description: Analysis Results Standard Ordered Grouping properties: order: type: integer example: 1 grouping: anyOf: - $ref: '#/components/schemas/arsSubjectGroupingFactorRef' - $ref: '#/components/schemas/arsDataGroupingFactorRef' dataGrouping: $ref: '#/components/schemas/arsDataGroupingFactor' arsReferencedAnalysisOperation: type: object description: Analysis Results Standard Referenced Analysis Operation properties: referencedOperationRelationship: $ref: '#/components/schemas/arsReferencedOperationRelationshipRef' analysis: $ref: '#/components/schemas/arsAnalysisRef' required: - referencedOperationRelationship - analysis arsAnalysisLinks: type: object properties: self: $ref: '#/components/schemas/arsAnalysisRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsAnalysis: type: object description: Analysis Results Standard Analysis properties: id: type: string example: An03.02_AgeGrp_ByTrt categories: type: array items: $ref: '#/components/schemas/arsAnalysisCategoryRef' analsysisSet: $ref: '#/components/schemas/arsAnalysisSetRef' orderedGroupings: type: array items: $ref: '#/components/schemas/arsOrderedGrouping' dataSubset: $ref: '#/components/schemas/arsDataSubsetRef' dataset: type: string example: ADSL variable: type: string example: USUBJID method: $ref: '#/components/schemas/arsAnalysisMethodRef' referenceAnalysisOperations: type: array items: $ref: '#/components/schemas/arsReferencedAnalysisOperation' results: type: array items: $ref: '#/components/schemas/arsOperationResult' _links: $ref: '#/components/schemas/arsAnalysisLinks' required: - id - name - dataset - variable - method arsResultGroup: type: object properties: grouping: anyOf: - $ref: '#/components/schemas/arsSubjectGroupingFactorRef' - $ref: '#/components/schemas/arsDataGroupingFactorRef' group: anyOf: - $ref: '#/components/schemas/arsAnalysisGroupRef' - $ref: '#/components/schemas/arsDataGroupRef' groupValue: type: string example: CARDIAC DISORDERS arsOperationResult: type: object description: Analysis Results Standard Operation Result properties: operation: $ref: '#/components/schemas/arsOperationRef' resultGroups: type: array items: $ref: '#/components/schemas/arsResultGroup' rawValue: type: string example: 16.2790697674419 formattedValue: type: string example: ( 16.3) arsOutputLinks: type: object properties: self: $ref: '#/components/schemas/arsOutputRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsOutput: type: object description: Analysis Results Standard Output properties: id: type: string example: Out14.1.1 version: type: integer example: 1 fileSpecifications: type: array items: $ref: '#/components/schemas/arsFile' outputDisplays: type: array items: $ref: '#/components/schemas/arsOutputDisplay' categories: type: array items: $ref: '#/components/schemas/arsAnalysisCategoryRef' _links: $ref: '#/components/schemas/arsOutputLinks' arsFile: type: object properties: fileType: type: string enum: - pdf - rtf - txt location: type: string style: type: string arsDisplayRef: type: object description: Analysis Results Standard Display Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/outputs/Out14.1.1/displays/Disp14.1.1 title: type: string example: Summary of Demographics type: type: string example: Analysis Results Standard Display arsDisplayLinks: type: object properties: self: $ref: '#/components/schemas/arsDisplayRef' parentOutput: $ref: '#/components/schemas/arsOutputRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsOutputDisplay: type: object properties: order: type: integer example: 1 display: $ref: '#/components/schemas/arsDisplayRef' arsDisplay: type: object description: Analysis Results Standard Display properties: id: type: string example: Disp14.1.1 name: type: string example: Demog displayTitle: type: string example: Summary of Demographics displaySections: type: array items: $ref: '#/components/schemas/arsDisplaySection' _links: $ref: '#/components/schemas/arsDisplayLinks' arsDisplaySection: type: object properties: sectionType: type: string enum: - Title - Footnote - Abbreviation - Legend - Rowlabel Header subSections: type: array items: $ref: '#/components/schemas/arsDisplaySubSection' arsDisplaySubSection: type: object description: Analysis Results Standard Display Subsection properties: id: type: string example: Disp14.1.1_Title_1 order: type: integer example: 1 text: type: string example: Table 14.1.1 arsAnalysisCategorizationLinks: type: object properties: self: $ref: '#/components/schemas/arsAnalysisCategorizationRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' arsAnalysisCategorization: type: object description: Analysis Results Standard Categorization properties: id: type: string example: AnCat1_Group label: type: string example: Group of Analyses categories: type: array items: $ref: '#/components/schemas/arsAnalysisCategoryRef' _links: $ref: '#/components/schemas/arsAnalysisCategorizationLinks' required: - id - label arsAnalysisCategoryRef: type: object description: Analysis Results Standard Category Reference properties: href: type: string example: /mdr/ars/packages/2023-10-26/reportingevents/ARS-CSD-v1/categorizations/AnCat1_Group/categories/AnCat1_Group_Safety title: type: string example: Safety Analyses type: type: string example: Analysis Results Standards Category arsAnalysisCategoryLinks: type: object properties: self: $ref: '#/components/schemas/arsAnalysisCategoryRef' parentCategorization: $ref: '#/components/schemas/arsAnalysisCategorizationRef' parentReportingEvent: $ref: '#/components/schemas/arsReportingEventRef' analyses: type: array items: $ref: '#/components/schemas/arsAnalysisRef' outputs: type: array items: $ref: '#/components/schemas/arsOutputRef' arsAnalysisCategory: type: object properties: id: type: string example: AnCat1_Group_Safety label: type: string example: Safety Analyses subCategorizations: type: array items: $ref: '#/components/schemas/arsAnalysisCategorizationRef' _links: $ref: '#/components/schemas/arsAnalysisCategoryLinks' required: - id - label