# baseURI: https://w3id.org/phuse/cdiscpilot01# # imports: http://www.w3.org/2004/02/skos/core # imports: https://w3id.org/phuse/cd01p # imports: https://w3id.org/phuse/code# # imports: https://w3id.org/phuse/sdtm # imports: https://w3id.org/phuse/study # prefix: cdiscpilot01 @prefix cd01p: . @prefix cdiscpilot01: . @prefix code: . @prefix cts: . @prefix custom: . @prefix meddra: . @prefix mms: . @prefix owl: . @prefix rdf: . @prefix rdfs: . @prefix sdtmterm: . @prefix skos: . @prefix sp: . @prefix spin: . @prefix study: . @prefix time: . @prefix xsd: . cd01p:Site_701 study:hasInvestigator cdiscpilot01:Investigator_123 ; . cd01p:Study_CDISCPILOT01 study:hasStudyActivity cdiscpilot01:DataCutoff_1 ; study:hasStudyParticipant cdiscpilot01:Person_01-701-1015 ; study:hasStudyParticipant cdiscpilot01:Person_01-701-1023 ; study:hasStudyParticipant cdiscpilot01:Person_01-701-1028 ; . cdiscpilot01: rdf:type owl:Ontology ; owl:imports ; owl:imports ; owl:imports code: ; owl:imports ; owl:imports ; owl:versionInfo "Created with TopBraid Composer" ; . cdiscpilot01:AE1_AppSiteErythema rdf:type study:AdverseEvent ; skos:prefLabel "APPLICATION SITE ERYTHEMA" ; code:hasCode meddra:m10003058 ; code:outcome code:AEOutcome_NRNR ; study:actionTaken "none" ; study:actionTakenOther "N/A" ; study:adverseEventPattern "SINGLE EVENT" ; study:cancer sdtmterm:NoYesResponse_N ; study:causality code:Causality_Probable ; study:concomitantTreatmentGiven sdtmterm:NoYesResponse_N ; study:congenitalDefect sdtmterm:NoYesResponse_N ; study:death sdtmterm:NoYesResponse_N ; study:disabling sdtmterm:NoYesResponse_N ; study:groupID "GRP1" ; study:hasCategory "CAT1" ; study:hasDataCollectionDate cdiscpilot01:Date_2014-01-16 ; study:hasInterval cdiscpilot01:Interval_2014-01-03_ ; study:hasSubcategory "SCAT1" ; study:hospitalization sdtmterm:NoYesResponse_N ; study:isPrespecified sdtmterm:NoYesResponse_Y ; study:lifeThreatening sdtmterm:NoYesResponse_N ; study:medicallyImportantSeriousEvent sdtmterm:NoYesResponse_N ; study:modifiedTerm "ERYTHEMA" ; study:overdose sdtmterm:NoYesResponse_N ; study:referenceID "REFID1" ; study:relationshipToNonStudyDrug "NONE" ; study:reportedTerm "APPLICATION SITE ERYTHEMA" ; study:seq "1"^^xsd:float ; study:serious sdtmterm:NoYesResponse_N ; study:severity code:Severity_MILD ; study:sponsordefinedID "E07" ; study:startDay 2 ; study:toxGrade 1 ; . cdiscpilot01:AE2_AppSitePruritus rdf:type study:AdverseEvent ; skos:prefLabel "APPLICATION SITE PRURITUS" ; code:hasCode meddra:m10003047 ; code:outcome code:AEOutcome_NRNR ; study:actionTaken "none" ; study:actionTakenOther "N/A" ; study:adverseEventPattern "SINGLE EVENT" ; study:cancer sdtmterm:NoYesResponse_N ; study:causality code:Causality_Probable ; study:concomitantTreatmentGiven sdtmterm:NoYesResponse_N ; study:congenitalDefect sdtmterm:NoYesResponse_N ; study:death sdtmterm:NoYesResponse_N ; study:disabling sdtmterm:NoYesResponse_N ; study:groupID "GRP1" ; study:hasCategory "CAT1" ; study:hasDataCollectionDate cdiscpilot01:Date_2014-01-16 ; study:hasInterval cdiscpilot01:Interval_2014-01-03_ ; study:hasSubcategory "SCAT1" ; study:hospitalization sdtmterm:NoYesResponse_N ; study:isPrespecified sdtmterm:NoYesResponse_Y ; study:lifeThreatening sdtmterm:NoYesResponse_N ; study:medicallyImportantSeriousEvent sdtmterm:NoYesResponse_N ; study:modifiedTerm "PRURITIS" ; study:overdose sdtmterm:NoYesResponse_N ; study:referenceID "REFID2" ; study:relationshipToNonStudyDrug "NONE" ; study:reportedTerm "APPLICATION SITE PRURITUS" ; study:seq "2"^^xsd:float ; study:serious sdtmterm:NoYesResponse_N ; study:severity code:Severity_MILD ; study:sponsordefinedID "E08" ; study:startDay 2 ; study:toxGrade 1 ; . cdiscpilot01:AE3_Diarrhoea rdf:type study:AdverseEvent ; skos:prefLabel "AE03 Diarrhoea" ; code:hasCode meddra:m10012727 ; code:outcome code:AEOutcome_RR ; study:actionTaken "none" ; study:actionTakenOther "N/A" ; study:adverseEventPattern "SINGLE EVENT" ; study:cancer sdtmterm:NoYesResponse_N ; study:causality code:Causality_Remote ; study:concomitantTreatmentGiven sdtmterm:NoYesResponse_N ; study:congenitalDefect sdtmterm:NoYesResponse_N ; study:death sdtmterm:NoYesResponse_N ; study:disabling sdtmterm:NoYesResponse_N ; study:endDay 10 ; study:groupID "GRP1" ; study:hasCategory "CAT1" ; study:hasDataCollectionDate cdiscpilot01:Date_2014-01-16 ; study:hasInterval cdiscpilot01:Interval_2014-01-09-2014-01-11 ; study:hasReferenceTimePointEndDate cdiscpilot01:Date_2014-01-13 ; study:hasSubcategory "SCAT1" ; study:hospitalization sdtmterm:NoYesResponse_N ; study:isPrespecified sdtmterm:NoYesResponse_N ; study:lifeThreatening sdtmterm:NoYesResponse_N ; study:medicallyImportantSeriousEvent sdtmterm:NoYesResponse_N ; study:modifiedTerm "DIARRHEA" ; study:overdose sdtmterm:NoYesResponse_N ; study:referenceID "REFID3" ; study:relationshipToNonStudyDrug "NONE" ; study:reportedTerm "DIARRHOEA" ; study:seq "3"^^xsd:float ; study:serious sdtmterm:NoYesResponse_N ; study:severity code:Severity_MILD ; study:sponsordefinedID "E06" ; study:startDay 8 ; study:toxGrade 1 ; . cdiscpilot01:AE4_AVBlock2ndDeg rdf:type study:AdverseEvent ; skos:prefLabel "AE04AVBlock2nd deg" ; code:hasCode meddra:m10003851 ; code:outcome code:AEOutcome_NRNR ; study:actionTaken "none" ; study:actionTakenOther "N/A" ; study:adverseEventPattern "SINGLE EVENT" ; study:cancer sdtmterm:NoYesResponse_N ; study:causality code:Causality_Possible ; study:concomitantTreatmentGiven sdtmterm:NoYesResponse_N ; study:congenitalDefect sdtmterm:NoYesResponse_N ; study:death sdtmterm:NoYesResponse_N ; study:disabling sdtmterm:NoYesResponse_N ; study:groupID "GRP2" ; study:hasCategory "CAT1" ; study:hasDataCollectionDate cdiscpilot01:Date_2012-08-27 ; study:hasInterval cdiscpilot01:Interval_2012-08-26_ ; study:hasSubcategory "SCAT1" ; study:hospitalization sdtmterm:NoYesResponse_N ; study:isPrespecified sdtmterm:NoYesResponse_N ; study:lifeThreatening sdtmterm:NoYesResponse_N ; study:medicallyImportantSeriousEvent sdtmterm:NoYesResponse_N ; study:modifiedTerm "AV BLOCK" ; study:overdose sdtmterm:NoYesResponse_N ; study:referenceID "REFID4" ; study:relationshipToNonStudyDrug "NONE" ; study:reportedTerm "ATRIOVENTRICULAR BLOCK SECOND DEGREE" ; study:seq "3"^^xsd:float ; study:serious sdtmterm:NoYesResponse_N ; study:severity code:Severity_MILD ; study:sponsordefinedID "E10" ; study:startDay 22 ; study:toxGrade 1 ; . cdiscpilot01:AE5_Erythema rdf:type study:AdverseEvent ; skos:prefLabel "AE05 Erythema" ; code:hasCode meddra:m10015150 ; code:outcome code:AEOutcome_NRNR ; study:actionTaken "none" ; study:actionTakenOther "N/A" ; study:adverseEventPattern "SINGLE EVENT" ; study:cancer sdtmterm:NoYesResponse_N ; study:causality code:Causality_Possible ; study:concomitantTreatmentGiven sdtmterm:NoYesResponse_N ; study:congenitalDefect sdtmterm:NoYesResponse_N ; study:death sdtmterm:NoYesResponse_N ; study:disabling sdtmterm:NoYesResponse_N ; study:endDay 26 ; study:groupID "GRP2" ; study:hasCategory "CAT1" ; study:hasDataCollectionDate cdiscpilot01:Date_2012-08-27 ; study:hasInterval cdiscpilot01:Interval_2012-08-07_2012-08-30 ; study:hasReferenceTimePointEndDate cdiscpilot01:Date_2012-08-06 ; study:hasSubcategory "SCAT1" ; study:hospitalization sdtmterm:NoYesResponse_N ; study:isPrespecified sdtmterm:NoYesResponse_N ; study:lifeThreatening sdtmterm:NoYesResponse_N ; study:medicallyImportantSeriousEvent sdtmterm:NoYesResponse_N ; study:modifiedTerm "ERYTHEMA" ; study:overdose sdtmterm:NoYesResponse_N ; study:referenceID "REFID5" ; study:relationshipToNonStudyDrug "NONE" ; study:reportedTerm "ERYTHEMA" ; study:seq "1"^^xsd:float ; study:serious sdtmterm:NoYesResponse_N ; study:severity code:Severity_MILD ; study:sponsordefinedID "E08" ; study:startDay 3 ; study:toxGrade 2 ; . cdiscpilot01:AE6_Erythema rdf:type study:AdverseEvent ; skos:prefLabel "AE06 Erythema" ; code:hasCode meddra:m10024781 ; code:outcome code:AEOutcome_NRNR ; study:actionTaken "dose reduction" ; study:actionTakenOther "N/A" ; study:adverseEventPattern "SINGLE EVENT" ; study:cancer sdtmterm:NoYesResponse_N ; study:causality code:Causality_Probable ; study:concomitantTreatmentGiven sdtmterm:NoYesResponse_N ; study:congenitalDefect sdtmterm:NoYesResponse_N ; study:death sdtmterm:NoYesResponse_N ; study:disabling sdtmterm:NoYesResponse_N ; study:groupID "GRP2" ; study:hasCategory "CAT1" ; study:hasDataCollectionDate cdiscpilot01:Date_2012-08-27 ; study:hasInterval cdiscpilot01:Interval_2012-08-07_ ; study:hasSubcategory "SCAT1" ; study:hospitalization sdtmterm:NoYesResponse_N ; study:isPrespecified sdtmterm:NoYesResponse_N ; study:lifeThreatening sdtmterm:NoYesResponse_N ; study:medicallyImportantSeriousEvent sdtmterm:NoYesResponse_N ; study:modifiedTerm "ERYTHEMA" ; study:overdose sdtmterm:NoYesResponse_N ; study:referenceID "REFID6" ; study:relationshipToNonStudyDrug "NONE" ; study:reportedTerm "ERYTHEMA" ; study:seq "2"^^xsd:float ; study:serious sdtmterm:NoYesResponse_N ; study:severity code:Severity_MODERATE ; study:sponsordefinedID "E09" ; study:startDay 3 ; study:toxGrade 1 ; . cdiscpilot01:AE7_Erythema rdf:type study:AdverseEvent ; skos:prefLabel "AE07 Erythema" ; code:hasCode meddra:m10015150 ; code:outcome code:AEOutcome_RR ; study:actionTaken "none" ; study:actionTakenOther "N/A" ; study:adverseEventPattern "SINGLE EVENT" ; study:cancer sdtmterm:NoYesResponse_N ; study:causality code:Causality_Possible ; study:concomitantTreatmentGiven sdtmterm:NoYesResponse_N ; study:congenitalDefect sdtmterm:NoYesResponse_N ; study:death sdtmterm:NoYesResponse_N ; study:disabling sdtmterm:NoYesResponse_N ; study:groupID "GRP2" ; study:hasCategory "CAT1" ; study:hasDataCollectionDate cdiscpilot01:Date_2012-09-02 ; study:hasInterval cdiscpilot01:Interval_2012-08-07_2012-08-30 ; study:hasReferenceTimePointEndDate cdiscpilot01:Date_2012-08-14 ; study:hasSubcategory "SCAT1" ; study:hospitalization sdtmterm:NoYesResponse_N ; study:isPrespecified sdtmterm:NoYesResponse_N ; study:lifeThreatening sdtmterm:NoYesResponse_N ; study:medicallyImportantSeriousEvent sdtmterm:NoYesResponse_N ; study:modifiedTerm "ERYTHEMA" ; study:overdose sdtmterm:NoYesResponse_N ; study:referenceID "REFID7" ; study:relationshipToNonStudyDrug "NONE" ; study:reportedTerm "ERYTHEMA" ; study:seq "4"^^xsd:float ; study:serious sdtmterm:NoYesResponse_N ; study:severity code:Severity_MILD ; study:sponsordefinedID "E08" ; study:startDay 3 ; study:toxGrade 1 ; . cdiscpilot01:AE8_AppSiteErythema rdf:type study:AdverseEvent ; skos:prefLabel "AE08 App site erythema" ; code:hasCode meddra:m10003041 ; code:outcome code:AEOutcome_NRNR ; study:actionTaken "none" ; study:actionTakenOther "N/A" ; study:adverseEventPattern "SINGLE EVENT" ; study:cancer sdtmterm:NoYesResponse_N ; study:causality code:Causality_Possible ; study:concomitantTreatmentGiven sdtmterm:NoYesResponse_N ; study:congenitalDefect sdtmterm:NoYesResponse_N ; study:death sdtmterm:NoYesResponse_N ; study:disabling sdtmterm:NoYesResponse_N ; study:endDay 26 ; study:groupID "GRP3" ; study:hasCategory "CAT1" ; study:hasDataCollectionDate cdiscpilot01:Date_2013-08-01 ; study:hasInterval cdiscpilot01:Interval_2013-07-21_ ; study:hasSubcategory "SCAT1" ; study:hospitalization sdtmterm:NoYesResponse_N ; study:isPrespecified sdtmterm:NoYesResponse_Y ; study:lifeThreatening sdtmterm:NoYesResponse_N ; study:medicallyImportantSeriousEvent sdtmterm:NoYesResponse_N ; study:modifiedTerm "ERYTHEMA" ; study:overdose sdtmterm:NoYesResponse_N ; study:referenceID "REFID8" ; study:relationshipToNonStudyDrug "NONE" ; study:reportedTerm "APPLICATION SITE ERYTHEMA" ; study:seq "1"^^xsd:float ; study:serious sdtmterm:NoYesResponse_N ; study:severity code:Severity_MILD ; study:sponsordefinedID "E04" ; study:startDay 3 ; study:toxGrade 1 ; . cdiscpilot01:AE9_AppSitePruritus rdf:type study:AdverseEvent ; skos:prefLabel "AE09 App site pruritis" ; code:hasCode meddra:m10003047 ; code:outcome code:AEOutcome_NRNR ; study:actionTaken "none" ; study:actionTakenOther "N/A" ; study:adverseEventPattern "SINGLE EVENT" ; study:cancer sdtmterm:NoYesResponse_N ; study:causality code:Causality_Probable ; study:concomitantTreatmentGiven sdtmterm:NoYesResponse_N ; study:congenitalDefect sdtmterm:NoYesResponse_N ; study:death sdtmterm:NoYesResponse_N ; study:disabling sdtmterm:NoYesResponse_N ; study:groupID "GRP3" ; study:hasCategory "CAT1" ; study:hasDataCollectionDate cdiscpilot01:Date_2013-08-14 ; study:hasInterval cdiscpilot01:Interval_2013-08-08_ ; study:hasSubcategory "SCAT1" ; study:hospitalization sdtmterm:NoYesResponse_N ; study:isPrespecified sdtmterm:NoYesResponse_Y ; study:lifeThreatening sdtmterm:NoYesResponse_N ; study:medicallyImportantSeriousEvent sdtmterm:NoYesResponse_N ; study:modifiedTerm "PRURITUS" ; study:overdose sdtmterm:NoYesResponse_N ; study:referenceID "REFID9" ; study:relationshipToNonStudyDrug "NONE" ; study:reportedTerm "APPLICATION SITE PRURITIS" ; study:seq "2"^^xsd:float ; study:serious sdtmterm:NoYesResponse_N ; study:severity code:Severity_MILD ; study:sponsordefinedID "E05" ; study:startDay 21 ; study:toxGrade 1 ; . cdiscpilot01:AgeDataCollection_01-701-1015 rdf:type code:AgeDataCollection ; skos:prefLabel "Person 01-701-1015 Screening 1 Age data collection" ; code:outcome cdiscpilot01:AgeOutcome_63 ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-12-26 ; . cdiscpilot01:AgeDataCollection_01-701-1023 rdf:type code:AgeDataCollection ; skos:prefLabel "Person 01-701-1023 Screening 1 Age data collection" ; code:outcome cdiscpilot01:AgeOutcome_64 ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2012-07-22 ; . cdiscpilot01:AgeDataCollection_01-701-1028 rdf:type code:AgeDataCollection ; skos:prefLabel "Person 01-701-1028 Screening 1 Age data collection" ; code:outcome cdiscpilot01:AgeOutcome_71 ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-07-11 ; . cdiscpilot01:AgeOutcome_63 rdf:type study:AgeOutcome ; skos:prefLabel "63 YEARS" ; code:hasUnit time:unitYear ; code:hasValue 63 ; . cdiscpilot01:AgeOutcome_64 rdf:type study:AgeOutcome ; skos:prefLabel "64 YEARS" ; code:hasUnit time:unitYear ; code:hasValue 64 ; . cdiscpilot01:AgeOutcome_71 rdf:type study:AgeOutcome ; skos:prefLabel "71 YEARS" ; code:hasUnit time:unitYear ; code:hasValue 71 ; . cdiscpilot01:AssumeBodyPositionStanding_Screening1_01-701-1015 rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type custom:AssumeBodyPositionStanding ; skos:prefLabel "Assume standing position" ; code:outcome code:BodyPosition_STANDING ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleLying5_Screening1_01-701-1015 ; . cdiscpilot01:AssumeBodyPositionSupine_Screening1_01-701-1015 rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type custom:AssumeBodyPositionSupine ; skos:prefLabel "Assume supine position" ; code:outcome code:BodyPosition_SUPINE ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-12-26 ; . cdiscpilot01:BloodPressureOutcome_129 rdf:type study:BloodPressureOutcome ; skos:prefLabel "129 mmHg" ; code:hasUnit code:Unit_mmHG ; code:hasValue 129 ; . cdiscpilot01:BloodPressureOutcome_131 rdf:type study:BloodPressureOutcome ; skos:prefLabel "131 mmHg" ; code:hasUnit code:Unit_mmHG ; code:hasValue 131 ; . cdiscpilot01:BloodPressureOutcome_147 rdf:type study:BloodPressureOutcome ; skos:prefLabel "147 mmHg" ; code:hasUnit code:Unit_mmHG ; code:hasValue 147 ; . cdiscpilot01:BloodPressureOutcome_57 rdf:type study:BloodPressureOutcome ; skos:prefLabel "57 mmHg" ; code:hasUnit code:Unit_mmHG ; code:hasValue 57 ; . cdiscpilot01:BloodPressureOutcome_64 rdf:type study:BloodPressureOutcome ; skos:prefLabel "64 mmHg" ; code:hasUnit code:Unit_mmHG ; code:hasValue 64 ; . cdiscpilot01:BloodPressureOutcome_83 rdf:type study:BloodPressureOutcome ; skos:prefLabel "83 mmHg" ; code:hasUnit code:Unit_mmHG ; code:hasValue 83 ; . cdiscpilot01:CumulativeDrugAdministration_01-701-1015 rdf:type study:CumulativeDrugAdministration ; skos:prefLabel "Drug administration period 2014-01-02 to 2014-07-02" ; study:activityStatus code:ActivityStatus_CO ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1015_2014-01-02_2014-01-16 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1015_2014-01-17_2014-06-18 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1015_2014-06-19_2014-07-02 ; study:hasActivityInterval cdiscpilot01:Interval_2014-01-02_2014-07-02 ; . cdiscpilot01:CumulativeDrugAdministration_01-701-1023 rdf:type study:CumulativeDrugAdministration ; skos:prefLabel "Drug administration period 2012-08-05 to 2012-09-01" ; study:activityStatus code:ActivityStatus_CO ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1023_2012-08-05_2012-08-27 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1023_2012-08-28_2012-09-01 ; study:hasActivityInterval cdiscpilot01:Interval_2012-08-05_2012-09-01 ; . cdiscpilot01:CumulativeDrugAdministration_01-701-1028 rdf:type study:CumulativeDrugAdministration ; skos:prefLabel "Drug administration period 2013-07-19 to 2014-01-14" ; study:activityStatus code:ActivityStatus_CO ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1028_2013-07-19_2013-08-01 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1028_2013-08-02_2014-01-06 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1028_2014-01-07_2014-01-14 ; study:hasActivityInterval cdiscpilot01:Interval_2013-07-19_2014-01-14 ; . cdiscpilot01:DataCutoff_1 rdf:type study:DataCutoff ; skos:prefLabel "Data cutoff 1" ; study:activityDescription "Interim Analysis Data Cutoff Date" ; study:hasDate cd01p:Date_2015-03-31 ; . cdiscpilot01:Date_1942-07-19 rdf:type study:Birthdate ; skos:prefLabel "1942-07-19" ; study:dateTimeInXSDString "1942-07-19" ; . cdiscpilot01:Date_1948-08-05 rdf:type study:Birthdate ; skos:prefLabel "1948-08-05" ; study:dateTimeInXSDString "1948-08-05" ; . cdiscpilot01:Date_1951-01-02 rdf:type study:Birthdate ; skos:prefLabel "1951-01-02" ; study:dateTimeInXSDString "1951-01-02" ; . cdiscpilot01:Date_2012-07-22 rdf:type study:DemogDataCollectionDate ; rdf:type study:InformedConsentBegin ; rdf:type study:StudyParticipationBegin ; rdf:type study:VisitDate ; skos:prefLabel "2012-07-22" ; study:dateTimeInXSDString "2012-07-22" ; . cdiscpilot01:Date_2012-08-05 rdf:type study:CumulativeDrugAdministrationBegin ; rdf:type study:FixedDoseIntervalBegin ; rdf:type study:ReferenceBegin ; skos:prefLabel "2012-08-05" ; study:dateTimeInXSDString "2012-08-05" ; . cdiscpilot01:Date_2012-08-06 rdf:type study:ReferenceEnd ; skos:prefLabel "2012-08-06" ; study:dateTimeInXSDString "2012-08-06" ; . cdiscpilot01:Date_2012-08-07 rdf:type study:AdverseEventBegin ; skos:prefLabel "2012-08-07" ; study:dateTimeInXSDString "2012-08-07" ; . cdiscpilot01:Date_2012-08-14 rdf:type study:ReferenceEnd ; skos:prefLabel "2012-08-14" ; study:dateTimeInXSDString "2012-08-14" ; . cdiscpilot01:Date_2012-08-26 rdf:type study:AdverseEventBegin ; skos:prefLabel "2012-08-26" ; study:dateTimeInXSDString "2012-08-26" ; . cdiscpilot01:Date_2012-08-27 rdf:type study:DataCollectionDate ; rdf:type study:FixedDoseIntervalEnd ; rdf:type study:VisitDate ; skos:prefLabel "2012-08-27" ; study:dateTimeInXSDString "2012-08-27" ; . cdiscpilot01:Date_2012-08-28 rdf:type study:FixedDoseIntervalBegin ; skos:prefLabel "2012-08-28" ; study:dateTimeInXSDString "2012-08-28" ; . cdiscpilot01:Date_2012-08-30 rdf:type study:AdverseEventEnd ; skos:prefLabel "2012-08-30" ; study:dateTimeInXSDString "2012-08-30" ; . cdiscpilot01:Date_2012-09-01 rdf:type study:CumulativeDrugAdministrationEnd ; rdf:type study:FixedDoseIntervalEnd ; skos:prefLabel "2012-09-01" ; study:dateTimeInXSDString "2012-09-01" ; . cdiscpilot01:Date_2012-09-02 rdf:type study:DataCollectionDate ; rdf:type study:ReferenceEnd ; skos:prefLabel "2012-09-02" ; study:dateTimeInXSDString "2012-09-02" ; . cdiscpilot01:Date_2013-02-18 rdf:type study:StudyParticipationEnd ; skos:prefLabel "2013-02-18" ; study:dateTimeInXSDString "2013-02-18" ; . cdiscpilot01:Date_2013-07-11 rdf:type study:DemogDataCollectionDate ; rdf:type study:InformedConsentBegin ; rdf:type study:StudyParticipationBegin ; rdf:type study:VisitDate ; skos:prefLabel "2013-07-11" ; study:dateTimeInXSDString "2013-07-11" ; . cdiscpilot01:Date_2013-07-19 rdf:type study:CumulativeDrugAdministrationBegin ; rdf:type study:FixedDoseIntervalBegin ; rdf:type study:ReferenceBegin ; skos:prefLabel "2013-07-19" ; study:dateTimeInXSDString "2013-07-19" ; . cdiscpilot01:Date_2013-07-21 rdf:type study:AdverseEventBegin ; skos:prefLabel "2013-07-21" ; study:dateTimeInXSDString "2013-07-21" ; . cdiscpilot01:Date_2013-08-01 rdf:type study:DataCollectionDate ; rdf:type study:FixedDoseIntervalEnd ; rdf:type study:VisitDate ; skos:prefLabel "2013-08-01" ; study:dateTimeInXSDString "2013-08-01" ; . cdiscpilot01:Date_2013-08-02 rdf:type study:FixedDoseIntervalBegin ; skos:prefLabel "2013-08-02" ; study:dateTimeInXSDString "2013-08-02" ; . cdiscpilot01:Date_2013-08-08 rdf:type study:AdverseEventBegin ; skos:prefLabel "2013-08-08" ; study:dateTimeInXSDString "2013-08-08" ; . cdiscpilot01:Date_2013-08-14 rdf:type study:DataCollectionDate ; skos:prefLabel "2013-08-14" ; study:dateTimeInXSDString "2013-08-14" ; . cdiscpilot01:Date_2013-12-26 rdf:type study:Deathdate ; rdf:type study:DemogDataCollectionDate ; rdf:type study:InformedConsentBegin ; rdf:type study:StudyParticipationBegin ; rdf:type study:VisitDate ; skos:prefLabel "2013-12-26" ; study:dateTimeInXSDString "2013-12-26" ; . cdiscpilot01:Date_2014-01-02 rdf:type study:CumulativeDrugAdministrationBegin ; rdf:type study:FixedDoseIntervalBegin ; rdf:type study:ReferenceBegin ; rdf:type study:VisitDate ; skos:prefLabel "2014-01-02" ; study:dateTimeInXSDString "2014-01-02" ; . cdiscpilot01:Date_2014-01-03 rdf:type study:AdverseEventBegin ; skos:prefLabel "2014-01-03" ; study:dateTimeInXSDString "2014-01-03" ; . cdiscpilot01:Date_2014-01-06 rdf:type study:VisitDate ; skos:prefLabel "2014-01-06" ; study:dateTimeInXSDString "2014-01-06" ; . cdiscpilot01:Date_2014-01-07 rdf:type study:FixedDoseIntervalBegin ; skos:prefLabel "2014-01-07" ; study:dateTimeInXSDString "2014-01-07" ; . cdiscpilot01:Date_2014-01-09 rdf:type study:AdverseEventBegin ; skos:prefLabel "2014-01-09" ; study:dateTimeInXSDString "2014-01-09" ; . cdiscpilot01:Date_2014-01-11 rdf:type study:AdverseEventEnd ; skos:prefLabel "2014-01-11" ; study:dateTimeInXSDString "2014-01-11" ; . cdiscpilot01:Date_2014-01-13 rdf:type study:ReferenceEnd ; skos:prefLabel "2014-01-13" ; study:dateTimeInXSDString "2014-01-13" ; . cdiscpilot01:Date_2014-01-14 rdf:type study:CumulativeDrugAdministrationEnd ; rdf:type study:FixedDoseIntervalEnd ; rdf:type study:ReferenceEnd ; rdf:type study:VisitDate ; skos:prefLabel "2014-01-14" ; study:dateTimeInXSDString "2014-01-14" ; . cdiscpilot01:Date_2014-01-14T11_10 rdf:type study:StudyParticipationEnd ; skos:prefLabel "2014-01-14T11:10" ; study:dateTimeInXSDString "2014-01-14T11:10" ; . cdiscpilot01:Date_2014-01-16 rdf:type study:DataCollectionDate ; rdf:type study:FixedDoseIntervalEnd ; rdf:type study:VisitDate ; skos:prefLabel "2014-01-16" ; study:dateTimeInXSDString "2014-01-16" ; . cdiscpilot01:Date_2014-01-17 rdf:type study:FixedDoseIntervalBegin ; skos:prefLabel "2014-01-17" ; study:dateTimeInXSDString "2014-01-17" ; . cdiscpilot01:Date_2014-06-18 rdf:type study:FixedDoseIntervalEnd ; rdf:type study:VisitDate ; skos:prefLabel "2014-06-18" ; study:dateTimeInXSDString "2014-06-18" ; . cdiscpilot01:Date_2014-06-19 rdf:type study:FixedDoseIntervalBegin ; skos:prefLabel "2014-06-19" ; study:dateTimeInXSDString "2014-06-19" ; . cdiscpilot01:Date_2014-07-02 rdf:type study:CumulativeDrugAdministrationEnd ; rdf:type study:FixedDoseIntervalEnd ; rdf:type study:ReferenceEnd ; rdf:type study:VisitDate ; skos:prefLabel "2014-07-02" ; study:dateTimeInXSDString "2014-07-02" ; . cdiscpilot01:Date_2014-07-02T11_45 rdf:type study:StudyParticipationEnd ; skos:prefLabel "2014-07-02T11:45" ; study:dateTimeInXSDString "2014-07-02T11:45" ; . cdiscpilot01:DemographicDataCollection_01-701-1015 rdf:type cd01p:VisitScreening1DemogDataColl ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:DemographicDataCollection ; skos:prefLabel "Person 01-701-1015 Screening 1 Demographic data collection" ; code:outcome code:Successfully_Completed ; study:activityStatus code:ActivityStatus_CO ; study:hasActivity cdiscpilot01:AgeDataCollection_01-701-1015 ; study:hasActivity cdiscpilot01:EthnicityDataCollection_01-701-1015 ; study:hasActivity cdiscpilot01:RaceDataCollection_01-701-1015 ; study:hasActivity cdiscpilot01:SexDataCollection_01-701-1015 ; study:hasDate cdiscpilot01:Date_2013-12-26 ; . cdiscpilot01:DemographicDataCollection_01-701-1023 rdf:type cd01p:VisitScreening1DemogDataColl ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1023 ; rdf:type code:DemographicDataCollection ; skos:prefLabel "Person 01-701-1023 Screening 1 Demographic data collection" ; code:outcome code:Successfully_Completed ; study:activityStatus code:ActivityStatus_CO ; study:hasActivity cdiscpilot01:AgeDataCollection_01-701-1023 ; study:hasActivity cdiscpilot01:EthnicityDataCollection_01-701-1023 ; study:hasActivity cdiscpilot01:RaceDataCollection_01-701-1023 ; study:hasActivity cdiscpilot01:SexDataCollection_01-701-1023 ; study:hasDate cdiscpilot01:Date_2012-07-22 ; . cdiscpilot01:DemographicDataCollection_01-701-1028 rdf:type cd01p:VisitScreening1DemogDataColl ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1028 ; rdf:type code:DemographicDataCollection ; skos:prefLabel "Person 01-701-1028 Screening 1 Demographic data collection" ; code:outcome code:Successfully_Completed ; study:activityStatus code:ActivityStatus_CO ; study:hasActivity cdiscpilot01:AgeDataCollection_01-701-1028 ; study:hasActivity cdiscpilot01:EthnicityDataCollection_01-701-1028 ; study:hasActivity cdiscpilot01:RaceDataCollection_01-701-1028 ; study:hasActivity cdiscpilot01:SexDataCollection_01-701-1028 ; study:hasDate cdiscpilot01:Date_2013-07-11 ; . cdiscpilot01:DiastolicBloodPressure_Screening1_01-701-1015_1 rdf:type cd01p:VisitScreening1DiastolicBloodPressure ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:DiastolicBloodPressure ; code:outcome cdiscpilot01:BloodPressureOutcome_64 ; study:activityStatus code:ActivityStatus_CO ; study:anatomicLocation code:Arm ; study:bodyPosition code:BodyPosition_SUPINE ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleLying5_Screening1_01-701-1015 ; study:hasSubcategory cd01p:Subcategory_1 ; study:laterality code:Laterality_RIGHT ; study:reasonNotDone "not applicable" ; study:seq "1"^^xsd:float ; study:sponsordefinedID "123" ; . cdiscpilot01:DiastolicBloodPressure_Screening1_01-701-1015_2 rdf:type cd01p:VisitScreening1DiastolicBloodPressure ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:DiastolicBloodPressure ; code:outcome cdiscpilot01:BloodPressureOutcome_83 ; study:activityStatus code:ActivityStatus_CO ; study:anatomicLocation code:Arm ; study:bodyPosition code:BodyPosition_STANDING ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleStanding1_Screening1_01-701-1015 ; study:hasSubcategory cd01p:Subcategory_1 ; study:laterality code:Laterality_LEFT ; study:reasonNotDone "not applicable" ; study:seq "2"^^xsd:float ; study:sponsordefinedID "719" ; . cdiscpilot01:DiastolicBloodPressure_Screening1_01-701-1015_3 rdf:type cd01p:VisitScreening1DiastolicBloodPressure ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:DiastolicBloodPressure ; code:outcome cdiscpilot01:BloodPressureOutcome_57 ; study:activityStatus code:ActivityStatus_CO ; study:anatomicLocation code:Arm ; study:bodyPosition code:BodyPosition_STANDING ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleStanding3_Screening1_01-701-1015 ; study:hasSubcategory cd01p:Subcategory_1 ; study:laterality code:Laterality_RIGHT ; study:reasonNotDone "not applicable" ; study:seq "3"^^xsd:float ; study:sponsordefinedID "235" ; . cdiscpilot01:DrugAdministration_01-701-1015_2014-01-02_2014-01-16 rdf:type cdiscpilot01:VisitBaselineActivity_01-701-1015 ; rdf:type study:FixedDoseDrugAdministration ; skos:prefLabel "Drug administration" ; code:outcome study:DrugAdministrationComplete ; study:activityStatus code:ActivityStatus_CO ; study:administeredDrug custom:PlaceboDrug ; study:hasActivityInterval cdiscpilot01:Interval_2014-01-02_2014-01-16 ; study:hasDosageFrequency code:ExDosFrq_QD ; study:hasRouteOfAdministration code:ExRoute_TRANSDERMAL ; . cdiscpilot01:DrugAdministration_01-701-1015_2014-01-17_2014-06-18 rdf:type cdiscpilot01:VisitWk2Activity_01-701-1015 ; rdf:type study:FixedDoseDrugAdministration ; skos:prefLabel "Drug administration" ; code:outcome study:DrugAdministrationComplete ; study:activityStatus code:ActivityStatus_CO ; study:administeredDrug custom:PlaceboDrug ; study:hasActivityInterval cdiscpilot01:Interval_2014-01-17_2014-06-18 ; study:hasDosageFrequency code:ExDosFrq_QD ; study:hasRouteOfAdministration code:ExRoute_TRANSDERMAL ; . cdiscpilot01:DrugAdministration_01-701-1015_2014-06-19_2014-07-02 rdf:type cdiscpilot01:VisitWk24Activity_01-701-1015 ; rdf:type study:FixedDoseDrugAdministration ; skos:prefLabel "Drug administration" ; code:outcome study:DrugAdministrationComplete ; study:activityStatus code:ActivityStatus_CO ; study:administeredDrug custom:PlaceboDrug ; study:hasActivityInterval cdiscpilot01:Interval_2014-06-19_2014-07-02 ; study:hasDosageFrequency code:ExDosFrq_QD ; study:hasRouteOfAdministration code:ExRoute_TRANSDERMAL ; . cdiscpilot01:DrugAdministration_01-701-1023_2012-08-05_2012-08-27 rdf:type cdiscpilot01:VisitBaselineActivity_01-701-1023 ; rdf:type study:FixedDoseDrugAdministration ; skos:prefLabel "Drug administration" ; code:outcome study:DrugAdministrationComplete ; study:activityStatus code:ActivityStatus_CO ; study:administeredDrug custom:PlaceboDrug ; study:hasActivityInterval cdiscpilot01:Interval_2012-08-05_2012-08-27 ; study:hasDosageFrequency code:ExDosFrq_QD ; study:hasRouteOfAdministration code:ExRoute_TRANSDERMAL ; . cdiscpilot01:DrugAdministration_01-701-1023_2012-08-28_2012-09-01 rdf:type cdiscpilot01:VisitWk2Activity_01-701-1023 ; rdf:type study:FixedDoseDrugAdministration ; skos:prefLabel "Drug administration" ; code:outcome study:DrugAdministrationComplete ; study:activityStatus code:ActivityStatus_CO ; study:administeredDrug custom:PlaceboDrug ; study:hasActivityInterval cdiscpilot01:Interval_2012-08-28_2012-09-01 ; study:hasDosageFrequency code:ExDosFrq_QD ; study:hasRouteOfAdministration code:ExRoute_TRANSDERMAL ; . cdiscpilot01:DrugAdministration_01-701-1028_2013-07-19_2013-08-01 rdf:type cdiscpilot01:VisitBaselineActivity_01-701-1028 ; rdf:type study:FixedDoseDrugAdministration ; skos:prefLabel "Drug administration" ; code:outcome study:DrugAdministrationComplete ; study:activityStatus code:ActivityStatus_CO ; study:administeredDrug custom:Product_1 ; study:hasActivityInterval cdiscpilot01:Interval_2013-07-19_2013-08-01 ; study:hasDosageFrequency code:ExDosFrq_QD ; study:hasRouteOfAdministration code:ExRoute_TRANSDERMAL ; . cdiscpilot01:DrugAdministration_01-701-1028_2013-08-02_2014-01-06 rdf:type cdiscpilot01:VisitWk2Activity_01-701-1028 ; rdf:type study:FixedDoseDrugAdministration ; skos:prefLabel "Drug administration" ; code:outcome study:DrugAdministrationComplete ; study:activityStatus code:ActivityStatus_CO ; study:administeredDrug custom:Product_2 ; study:hasActivityInterval cdiscpilot01:Interval_2013-08-02_2014-01-06 ; study:hasDosageFrequency code:ExDosFrq_QD ; study:hasRouteOfAdministration code:ExRoute_TRANSDERMAL ; . cdiscpilot01:DrugAdministration_01-701-1028_2014-01-07_2014-01-14 rdf:type cdiscpilot01:VisitWk24Activity_01-701-1028 ; rdf:type study:FixedDoseDrugAdministration ; skos:prefLabel "Drug administration" ; code:outcome study:DrugAdministrationComplete ; study:activityStatus code:ActivityStatus_CO ; study:administeredDrug custom:Product_1 ; study:hasActivityInterval cdiscpilot01:Interval_2014-01-07_2014-01-14 ; study:hasDosageFrequency code:ExDosFrq_QD ; study:hasRouteOfAdministration code:ExRoute_TRANSDERMAL ; . cdiscpilot01:EthnicityDataCollection_01-701-1015 rdf:type code:EthnicityDataCollection ; skos:prefLabel "Person 01-701-1015 Screening 1 Ethnicity data collection" ; code:outcome code:Ethnicity_HISPANIC_OR_LATINO ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-12-26 ; . cdiscpilot01:EthnicityDataCollection_01-701-1023 rdf:type code:EthnicityDataCollection ; skos:prefLabel "Person 01-701-1023 Screening 1 Ethnicity data collection" ; code:outcome code:Ethnicity_HISPANIC_OR_LATINO ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2012-07-22 ; . cdiscpilot01:EthnicityDataCollection_01-701-1028 rdf:type code:EthnicityDataCollection ; skos:prefLabel "Person 01-701-1028 Screening 1 Ethnicity data collection" ; code:outcome code:Ethnicity_NOT_HISPANIC_OR_LATINO ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-07-11 ; . cdiscpilot01:HeightOutcome_58_0 rdf:type study:HeightOutcome ; skos:prefLabel "58.0 in" ; code:hasUnit code:Unit_IN ; code:hasValue "58.0"^^xsd:float ; . cdiscpilot01:Height_Screening1_01-701-1015_43 rdf:type cd01p:VisitScreening1Height ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:Height ; code:outcome cdiscpilot01:HeightOutcome_58_0 ; study:activityStatus code:ActivityStatus_CO ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasSubcategory cd01p:Subcategory_1 ; study:reasonNotDone "not applicable" ; study:seq "43"^^xsd:float ; study:sponsordefinedID "1000" ; . cdiscpilot01:InformedConsentAdult_01-701-1015 rdf:type code:InformedConsentAdult ; skos:prefLabel "Informed consent Person 01-701-1015" ; code:outcome code:InformedConsentOutcome_1 ; study:activityStatus code:ActivityStatus_CO ; study:hasActivityInterval cdiscpilot01:Interval_2013-12-26_ ; study:hasStartRule study:StartRuleDefault_1 ; . cdiscpilot01:InformedConsentAdult_01-701-1023 rdf:type code:InformedConsentAdult ; skos:prefLabel "Informed consent Person 01-701-1023" ; code:outcome code:InformedConsentOutcome_1 ; study:activityStatus code:ActivityStatus_CO ; study:hasActivityInterval cdiscpilot01:Interval_2012-07-22_ ; . cdiscpilot01:InformedConsentAdult_01-701-1028 rdf:type code:InformedConsentAdult ; skos:prefLabel "Informed consent Person 01-701-1028" ; code:outcome code:InformedConsentOutcome_1 ; study:activityStatus code:ActivityStatus_CO ; study:hasActivityInterval cdiscpilot01:Interval_2013-07-11_ ; . cdiscpilot01:Interval_1942-07-19_ rdf:type study:Lifespan ; skos:prefLabel "Interval 1942-07-19 to " ; time:hasBeginning cdiscpilot01:Date_1942-07-19 ; . cdiscpilot01:Interval_1948-08-05_ rdf:type study:Lifespan ; skos:prefLabel "Interval 1948-08-05 to " ; time:hasBeginning cdiscpilot01:Date_1948-08-05 ; . cdiscpilot01:Interval_1951-01-02_2013-12-26 rdf:type study:Lifespan ; skos:prefLabel "Interval 1951-01-02 to 2013-12-26" ; time:hasBeginning cdiscpilot01:Date_1951-01-02 ; time:hasEnd cdiscpilot01:Date_2013-12-26 ; . cdiscpilot01:Interval_2012-07-22_ rdf:type study:InformedConsentInterval ; skos:prefLabel "Interval 2012-07-22 to " ; time:hasBeginning cdiscpilot01:Date_2012-07-22 ; . cdiscpilot01:Interval_2012-07-22_2013-02-18 rdf:type study:StudyParticipationInterval ; skos:prefLabel "Interval 2012-07-22 to 2013-02-18" ; time:hasBeginning cdiscpilot01:Date_2012-07-22 ; time:hasEnd cdiscpilot01:Date_2013-02-18 ; . cdiscpilot01:Interval_2012-08-05_2012-08-27 rdf:type study:FixedDoseInterval ; skos:prefLabel "Interval 2012-08-05 to 2012-08-27" ; time:hasBeginning cdiscpilot01:Date_2012-08-05 ; time:hasEnd cdiscpilot01:Date_2012-08-27 ; . cdiscpilot01:Interval_2012-08-05_2012-09-01 rdf:type study:CumulativeDrugAdministrationInterval ; skos:prefLabel "Interval 2012-08-05 to 2012-09-01" ; time:hasBeginning cdiscpilot01:Date_2012-08-05 ; time:hasEnd cdiscpilot01:Date_2012-09-01 ; . cdiscpilot01:Interval_2012-08-05_2012-09-02 rdf:type study:ReferenceInterval ; skos:prefLabel "Interval 2012-08-05 to 2012-09-02" ; time:hasBeginning cdiscpilot01:Date_2012-08-05 ; time:hasEnd cdiscpilot01:Date_2012-09-02 ; . cdiscpilot01:Interval_2012-08-07_ rdf:type study:AdverseEventInterval ; skos:prefLabel "Interval 2012-08-07 to" ; time:hasBeginning cdiscpilot01:Date_2012-08-07 ; . cdiscpilot01:Interval_2012-08-07_2012-08-30 rdf:type study:AdverseEventInterval ; skos:prefLabel "Interval 2012-08-07 to" ; time:hasBeginning cdiscpilot01:Date_2012-08-07 ; time:hasEnd cdiscpilot01:Date_2012-08-30 ; . cdiscpilot01:Interval_2012-08-26_ rdf:type study:AdverseEventInterval ; skos:prefLabel "Interval 2012-08-26 to" ; time:hasBeginning cdiscpilot01:Date_2012-08-26 ; . cdiscpilot01:Interval_2012-08-28_2012-09-01 rdf:type study:FixedDoseInterval ; skos:prefLabel "Interval 2012-08-28 to 2012-09-01" ; time:hasBeginning cdiscpilot01:Date_2012-08-28 ; time:hasEnd cdiscpilot01:Date_2012-09-01 ; . cdiscpilot01:Interval_2013-07-11_ rdf:type study:InformedConsentInterval ; skos:prefLabel "Interval 2013-07-11 to " ; time:hasBeginning cdiscpilot01:Date_2013-07-11 ; . cdiscpilot01:Interval_2013-07-11_2014-01-14T11_10 rdf:type study:StudyParticipationInterval ; skos:prefLabel "Interval 2013-07-11 to 2014-01-14T11:10" ; time:hasBeginning cdiscpilot01:Date_2013-07-11 ; time:hasEnd cdiscpilot01:Date_2014-01-14T11_10 ; . cdiscpilot01:Interval_2013-07-19_2013-08-01 rdf:type study:FixedDoseInterval ; skos:prefLabel "Interval 2013-07-19 to 2013-08-01" ; time:hasBeginning cdiscpilot01:Date_2013-07-19 ; time:hasEnd cdiscpilot01:Date_2013-08-01 ; . cdiscpilot01:Interval_2013-07-19_2014-01-14 rdf:type study:CumulativeDrugAdministrationInterval ; rdf:type study:ReferenceInterval ; skos:prefLabel "Interval 2013-07-19 to 2014-01-14" ; time:hasBeginning cdiscpilot01:Date_2013-07-19 ; time:hasEnd cdiscpilot01:Date_2014-01-14 ; . cdiscpilot01:Interval_2013-07-21_ rdf:type study:AdverseEventInterval ; skos:prefLabel "Interval 2013-07-21 to" ; time:hasBeginning cdiscpilot01:Date_2013-07-21 ; . cdiscpilot01:Interval_2013-08-02_2014-01-06 rdf:type study:FixedDoseInterval ; skos:prefLabel "Interval 2013-08-02 to 2014-01-06" ; time:hasBeginning cdiscpilot01:Date_2013-08-02 ; time:hasEnd cdiscpilot01:Date_2014-01-06 ; . cdiscpilot01:Interval_2013-08-08_ rdf:type study:AdverseEventInterval ; skos:prefLabel "Interval 2013-08-08 to" ; time:hasBeginning cdiscpilot01:Date_2013-08-08 ; . cdiscpilot01:Interval_2013-12-26_ rdf:type study:InformedConsentInterval ; skos:prefLabel "Interval 2013-12-26 to " ; time:hasBeginning cdiscpilot01:Date_2013-12-26 ; . cdiscpilot01:Interval_2013-12-26_2014-07-02T11_45 rdf:type study:StudyParticipationInterval ; skos:prefLabel "Interval 2013-12-26 to 2014-07-02T11:45" ; time:hasBeginning cdiscpilot01:Date_2013-12-26 ; time:hasEnd cdiscpilot01:Date_2014-07-02T11_45 ; . cdiscpilot01:Interval_2014-01-02_2014-01-16 rdf:type study:FixedDoseInterval ; skos:prefLabel "Interval 2014-01-02 to 2014-01-16" ; time:hasBeginning cdiscpilot01:Date_2014-01-02 ; time:hasEnd cdiscpilot01:Date_2014-01-16 ; . cdiscpilot01:Interval_2014-01-02_2014-07-02 rdf:type study:CumulativeDrugAdministrationInterval ; rdf:type study:ReferenceInterval ; skos:prefLabel "Interval 2014-01-02 to 2014-07-02" ; time:hasBeginning cdiscpilot01:Date_2014-01-02 ; time:hasEnd cdiscpilot01:Date_2014-07-02 ; . cdiscpilot01:Interval_2014-01-03_ rdf:type study:AdverseEventInterval ; skos:prefLabel "Interval 2014-01-03 to" ; time:hasBeginning cdiscpilot01:Date_2014-01-03 ; . cdiscpilot01:Interval_2014-01-07_2014-01-14 rdf:type study:FixedDoseInterval ; skos:prefLabel "Interval 2014-01-07 to 2014-01-14" ; time:hasBeginning cdiscpilot01:Date_2014-01-07 ; time:hasEnd cdiscpilot01:Date_2014-01-14 ; . cdiscpilot01:Interval_2014-01-09-2014-01-11 rdf:type study:AdverseEventInterval ; skos:prefLabel "Interval 2014-01-09 to 2014_01_11" ; time:hasBeginning cdiscpilot01:Date_2014-01-09 ; time:hasEnd cdiscpilot01:Date_2014-01-11 ; . cdiscpilot01:Interval_2014-01-17_2014-06-18 rdf:type study:FixedDoseInterval ; skos:prefLabel "Interval 2014-01-17 to 2014-06-18" ; time:hasBeginning cdiscpilot01:Date_2014-01-17 ; time:hasEnd cdiscpilot01:Date_2014-06-18 ; . cdiscpilot01:Interval_2014-06-19_2014-07-02 rdf:type study:FixedDoseInterval ; skos:prefLabel "Interval 2014-06-19 to 2014-07-02" ; time:hasBeginning cdiscpilot01:Date_2014-06-19 ; time:hasEnd cdiscpilot01:Date_2014-07-02 ; . cdiscpilot01:InvestigatorIdentifier_123 rdf:type study:InvestigatorIdentifier ; skos:prefLabel "123" ; . cdiscpilot01:Investigator_123 rdf:type study:Investigator ; skos:prefLabel "Investigator 123" ; study:hasInvestigatorID cdiscpilot01:InvestigatorIdentifier_123 ; study:hasLastName "Jones" ; . cdiscpilot01:Person_01-701-1015 rdf:type study:EnrolledSubject ; skos:prefLabel "Person 01-701-1015" ; study:actualArm cd01p:Arm_Pbo ; study:afflictedBy cdiscpilot01:AE1_AppSiteErythema ; study:afflictedBy cdiscpilot01:AE2_AppSitePruritus ; study:afflictedBy cdiscpilot01:AE3_Diarrhoea ; study:deathFlag "Y" ; study:hasLifespan cdiscpilot01:Interval_1951-01-02_2013-12-26 ; study:hasReferenceInterval cdiscpilot01:Interval_2014-01-02_2014-07-02 ; study:hasSite cd01p:Site_701 ; study:hasStudyParticipationInterval cdiscpilot01:Interval_2013-12-26_2014-07-02T11_45 ; study:hasSubjectID cdiscpilot01:SubjectIdentifier_1015 ; study:hasUniqueSubjectID cdiscpilot01:UniqueSubjectIdentifier_01-701-1015 ; study:participatesIn cdiscpilot01:CumulativeDrugAdministration_01-701-1015 ; study:participatesIn cdiscpilot01:DemographicDataCollection_01-701-1015 ; study:participatesIn cdiscpilot01:InformedConsentAdult_01-701-1015 ; study:participatesIn cdiscpilot01:PopFlagCOMPLT16_01-701-1015 ; study:participatesIn cdiscpilot01:PopFlagCOMPLT24_01-701-1015 ; study:participatesIn cdiscpilot01:PopFlagCOMPLT8_01-701-1015 ; study:participatesIn cdiscpilot01:PopFlagEFFICACY_01-701-1015 ; study:participatesIn cdiscpilot01:PopFlagITT_01-701-1015 ; study:participatesIn cdiscpilot01:PopFlagSAFETY_01-701-1015 ; study:participatesIn cdiscpilot01:RandomizationBAL3_01-701-1015 ; study:participatesIn cdiscpilot01:VisitBaseline_01-701-1015 ; study:participatesIn cdiscpilot01:VisitScreening1_01-701-1015 ; study:participatesIn cdiscpilot01:VisitWk24_01-701-1015 ; study:participatesIn cdiscpilot01:VisitWk2_01-701-1015 ; . cdiscpilot01:Person_01-701-1023 rdf:type study:EnrolledSubject ; skos:prefLabel "Person 01-701-1023" ; study:actualArm cd01p:Arm_Pbo ; study:afflictedBy cdiscpilot01:AE4_AVBlock2ndDeg ; study:afflictedBy cdiscpilot01:AE5_Erythema ; study:afflictedBy cdiscpilot01:AE6_Erythema ; study:afflictedBy cdiscpilot01:AE7_Erythema ; study:hasLifespan cdiscpilot01:Interval_1948-08-05_ ; study:hasReferenceInterval cdiscpilot01:Interval_2012-08-05_2012-09-02 ; study:hasSite cd01p:Site_701 ; study:hasStudyParticipationInterval cdiscpilot01:Interval_2012-07-22_2013-02-18 ; study:hasSubjectID cdiscpilot01:SubjectIdentifier_1023 ; study:hasUniqueSubjectID cdiscpilot01:UniqueSubjectIdentifier_01-701-1023 ; study:participatesIn cdiscpilot01:CumulativeDrugAdministration_01-701-1023 ; study:participatesIn cdiscpilot01:DemographicDataCollection_01-701-1023 ; study:participatesIn cdiscpilot01:InformedConsentAdult_01-701-1023 ; study:participatesIn cdiscpilot01:RandomizationBAL3_01-701-1023 ; study:participatesIn cdiscpilot01:VisitBaseline_01-701-1023 ; study:participatesIn cdiscpilot01:VisitScreening1_01-701-1023 ; study:participatesIn cdiscpilot01:VisitWk2_01-701-1023 ; . cdiscpilot01:Person_01-701-1028 rdf:type study:EnrolledSubject ; skos:prefLabel "Person 01-701-1028" ; study:actualArm cd01p:Arm_Xan_Hi ; study:afflictedBy cdiscpilot01:AE8_AppSiteErythema ; study:afflictedBy cdiscpilot01:AE9_AppSitePruritus ; study:hasLifespan cdiscpilot01:Interval_1942-07-19_ ; study:hasReferenceInterval cdiscpilot01:Interval_2013-07-19_2014-01-14 ; study:hasSite cd01p:Site_701 ; study:hasStudyParticipationInterval cdiscpilot01:Interval_2013-07-11_2014-01-14T11_10 ; study:hasSubjectID cdiscpilot01:SubjectIdentifier_1028 ; study:hasUniqueSubjectID cdiscpilot01:UniqueSubjectIdentifier_01-701-1028 ; study:participatesIn cdiscpilot01:CumulativeDrugAdministration_01-701-1028 ; study:participatesIn cdiscpilot01:DemographicDataCollection_01-701-1028 ; study:participatesIn cdiscpilot01:InformedConsentAdult_01-701-1028 ; study:participatesIn cdiscpilot01:RandomizationBAL3_01-701-1028 ; study:participatesIn cdiscpilot01:VisitBaseline_01-701-1028 ; study:participatesIn cdiscpilot01:VisitScreening1_01-701-1028 ; study:participatesIn cdiscpilot01:VisitWk24_01-701-1028 ; study:participatesIn cdiscpilot01:VisitWk2_01-701-1028 ; . cdiscpilot01:PopFlagCOMPLT16_01-701-1015 rdf:type custom:PopFlagCOMPLT16 ; code:outcome "true"^^xsd:boolean ; study:activityStatus code:ActivityStatus_CO ; study:hasPerformer cd01p:Sponsor_1 ; . cdiscpilot01:PopFlagCOMPLT24_01-701-1015 rdf:type custom:PopFlagCOMPLT24 ; code:outcome "true"^^xsd:boolean ; study:activityStatus code:ActivityStatus_CO ; study:hasPerformer cd01p:Sponsor_1 ; . cdiscpilot01:PopFlagCOMPLT8_01-701-1015 rdf:type custom:PopFlagCOMPLT8 ; code:outcome "true"^^xsd:boolean ; study:activityStatus code:ActivityStatus_CO ; study:hasPerformer cd01p:Sponsor_1 ; . cdiscpilot01:PopFlagEFFICACY_01-701-1015 rdf:type custom:PopFlagEFFICACY ; code:outcome "true"^^xsd:boolean ; study:activityStatus code:ActivityStatus_CO ; study:hasPerformer cd01p:Sponsor_1 ; . cdiscpilot01:PopFlagITT_01-701-1015 rdf:type custom:PopFlagITT ; code:outcome "true"^^xsd:boolean ; study:activityStatus code:ActivityStatus_CO ; study:hasPerformer cd01p:Sponsor_1 ; . cdiscpilot01:PopFlagSAFETY_01-701-1015 rdf:type custom:PopFlagSAFETY ; code:outcome "true"^^xsd:boolean ; study:activityStatus code:ActivityStatus_CO ; study:hasPerformer cd01p:Sponsor_1 ; . cdiscpilot01:PulseOutcome_57 rdf:type study:PulseOutcome ; skos:prefLabel "57 beats/min" ; code:hasUnit code:Unit_BEATS_MIN ; code:hasValue 57 ; . cdiscpilot01:PulseOutcome_62 rdf:type study:PulseOutcome ; skos:prefLabel "62 beats/min" ; code:hasUnit code:Unit_BEATS_MIN ; code:hasValue 62 ; . cdiscpilot01:PulseOutcome_65 rdf:type study:PulseOutcome ; skos:prefLabel "65 beats/min" ; code:hasUnit code:Unit_BEATS_MIN ; code:hasValue 65 ; . cdiscpilot01:Pulse_Screening1_01-701-1015_44 rdf:type cd01p:VisitScreening1Pulse ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:Pulse ; code:outcome cdiscpilot01:PulseOutcome_57 ; study:activityStatus code:ActivityStatus_CO ; study:bodyPosition code:BodyPosition_SUPINE ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleLying5_Screening1_01-701-1015 ; study:hasSubcategory cd01p:Subcategory_1 ; study:laterality code:Laterality_RIGHT ; study:reasonNotDone "not applicable" ; study:seq "44"^^xsd:float ; study:sponsordefinedID "125" ; . cdiscpilot01:Pulse_Screening1_01-701-1015_45 rdf:type cd01p:VisitScreening1Pulse ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:Pulse ; code:outcome cdiscpilot01:PulseOutcome_62 ; study:activityStatus code:ActivityStatus_CO ; study:bodyPosition code:BodyPosition_STANDING ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleStanding1_Screening1_01-701-1015 ; study:hasSubcategory cd01p:Subcategory_1 ; study:laterality code:Laterality_LEFT ; study:reasonNotDone "not applicable" ; study:seq "45"^^xsd:float ; study:sponsordefinedID "721" ; . cdiscpilot01:Pulse_Screening1_01-701-1015_46 rdf:type cd01p:VisitScreening1Pulse ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:Pulse ; code:outcome cdiscpilot01:PulseOutcome_65 ; study:activityStatus code:ActivityStatus_CO ; study:bodyPosition code:BodyPosition_STANDING ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleStanding3_Screening1_01-701-1015 ; study:hasSubcategory cd01p:Subcategory_1 ; study:laterality code:Laterality_RIGHT ; study:reasonNotDone "not applicable" ; study:seq "46"^^xsd:float ; study:sponsordefinedID "237" ; . cdiscpilot01:RaceDataCollection_01-701-1015 rdf:type code:RaceDataCollection ; skos:prefLabel "Person 01-701-1015 Screening 1 Race data collection" ; code:outcome code:Race_WHITE ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-12-26 ; . cdiscpilot01:RaceDataCollection_01-701-1023 rdf:type code:RaceDataCollection ; skos:prefLabel "Person 01-701-1023 Screening 1 Race data collection" ; code:outcome code:Race_WHITE ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2012-07-22 ; . cdiscpilot01:RaceDataCollection_01-701-1028 rdf:type code:RaceDataCollection ; skos:prefLabel "Person 01-701-1028 Screening 1 Race data collection" ; code:outcome code:Race_WHITE ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-07-11 ; . cdiscpilot01:RandomizationBAL3_01-701-1015 rdf:type code:RandomizationBAL3 ; skos:prefLabel "Randomization Person 01-701-1015" ; code:outcome cd01p:Arm_Pbo ; study:activityStatus code:ActivityStatus_CO ; . cdiscpilot01:RandomizationBAL3_01-701-1023 rdf:type code:RandomizationBAL3 ; skos:prefLabel "Randomization Person 01-701-1023" ; code:outcome cd01p:Arm_Pbo ; study:activityStatus code:ActivityStatus_CO ; . cdiscpilot01:RandomizationBAL3_01-701-1028 rdf:type code:RandomizationBAL3 ; skos:prefLabel "Randomization Person 01-701-1028" ; code:outcome cd01p:Arm_Xan_Hi ; study:activityStatus code:ActivityStatus_CO ; . cdiscpilot01:SexDataCollection_01-701-1015 rdf:type code:SexDataCollection ; skos:prefLabel "Person 01-701-1015 Screening 1 Sex data collection" ; code:outcome code:Sex_F ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-12-26 ; . cdiscpilot01:SexDataCollection_01-701-1023 rdf:type code:SexDataCollection ; skos:prefLabel "Person 01-701-1023 Screening 1 Sex data collection" ; code:outcome code:Sex_M ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2012-07-22 ; . cdiscpilot01:SexDataCollection_01-701-1028 rdf:type code:SexDataCollection ; skos:prefLabel "Person 01-701-1028 Screening 1 Sex data collection" ; code:outcome code:Sex_M ; study:activityStatus code:ActivityStatus_CO ; study:hasDate cdiscpilot01:Date_2013-07-11 ; . cdiscpilot01:StartRuleLying5_Screening1_01-701-1015 rdf:type cd01p:StartRuleLying5 ; skos:prefLabel "Person 01-701-1015 Screening 1 Rule after lying down for 5 minutes" ; study:hasPrerequisite cdiscpilot01:AssumeBodyPositionSupine_Screening1_01-701-1015 ; . cdiscpilot01:StartRuleStanding1_Screening1_01-701-1015 rdf:type cd01p:StartRuleStanding1 ; skos:prefLabel "Person 01-701-1015 Screening 1 Rule after standing for 1 minute" ; study:hasPrerequisite cdiscpilot01:AssumeBodyPositionStanding_Screening1_01-701-1015 ; . cdiscpilot01:StartRuleStanding3_Screening1_01-701-1015 rdf:type cd01p:StartRuleStanding3 ; skos:prefLabel "Person 01-701-1015 Screening 1 Rule after standing for 3 minutes" ; study:hasPrerequisite cdiscpilot01:AssumeBodyPositionStanding_Screening1_01-701-1015 ; . cdiscpilot01:StudyBegin_1 rdf:type study:StudyBegin ; skos:prefLabel "Study begin 1" ; study:dateTimeInXSDString "2012-07-06" ; . cdiscpilot01:StudyEnd_1 rdf:type study:StudyEnd ; skos:prefLabel "Study end 1" ; study:dateTimeInXSDString "2015-03-05" ; . cdiscpilot01:SubjectIdentifier_1015 rdf:type study:SubjectIdentifier ; skos:prefLabel "1015" ; . cdiscpilot01:SubjectIdentifier_1023 rdf:type study:SubjectIdentifier ; skos:prefLabel "1023" ; . cdiscpilot01:SubjectIdentifier_1028 rdf:type study:SubjectIdentifier ; skos:prefLabel "1028" ; . cdiscpilot01:SystolicBloodPressure_Screening1_01-701-1015_86 rdf:type cd01p:VisitScreening1SystolicBloodPressure ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:SystolicBloodPressure ; code:outcome cdiscpilot01:BloodPressureOutcome_131 ; study:activityStatus code:ActivityStatus_CO ; study:anatomicLocation code:Arm ; study:bodyPosition code:BodyPosition_SUPINE ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleLying5_Screening1_01-701-1015 ; study:hasSubcategory cd01p:Subcategory_1 ; study:laterality code:Laterality_RIGHT ; study:reasonNotDone "not applicable" ; study:seq "86"^^xsd:float ; study:sponsordefinedID "124" ; . cdiscpilot01:SystolicBloodPressure_Screening1_01-701-1015_87 rdf:type cd01p:VisitScreening1SystolicBloodPressure ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:SystolicBloodPressure ; code:outcome cdiscpilot01:BloodPressureOutcome_129 ; study:activityStatus code:ActivityStatus_CO ; study:anatomicLocation code:Arm ; study:bodyPosition code:BodyPosition_STANDING ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleStanding1_Screening1_01-701-1015 ; study:hasSubcategory cd01p:Subcategory_1 ; study:laterality code:Laterality_LEFT ; study:reasonNotDone "not applicable" ; study:seq "87"^^xsd:float ; study:sponsordefinedID "720" ; . cdiscpilot01:SystolicBloodPressure_Screening1_01-701-1015_88 rdf:type cd01p:VisitScreening1SystolicBloodPressure ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:SystolicBloodPressure ; code:outcome cdiscpilot01:BloodPressureOutcome_147 ; study:activityStatus code:ActivityStatus_CO ; study:anatomicLocation code:Arm ; study:bodyPosition code:BodyPosition_STANDING ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasStartRule cdiscpilot01:StartRuleStanding3_Screening1_01-701-1015 ; study:hasSubcategory cd01p:Subcategory_1 ; study:laterality code:Laterality_RIGHT ; study:reasonNotDone "not applicable" ; study:seq "88"^^xsd:float ; study:sponsordefinedID "236" ; . cdiscpilot01:TemperatureOutcome_96_9 rdf:type study:TemperatureOutcome ; skos:prefLabel "96.9 F" ; code:hasUnit code:Unit_F ; code:hasValue "96.9"^^xsd:float ; . cdiscpilot01:Temperature_Screening1_01-701-1015_128 rdf:type cd01p:VisitScreening1Temperature ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:Temperature ; code:outcome cdiscpilot01:TemperatureOutcome_96_9 ; study:activityStatus code:ActivityStatus_CO ; study:anatomicLocation code:Oral_Cavity ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasSubcategory cd01p:Subcategory_1 ; study:reasonNotDone "not applicable" ; study:seq "128"^^xsd:float ; study:sponsordefinedID "3000" ; . cdiscpilot01:UniqueSubjectIdentifier_01-701-1015 rdf:type study:UniqueSubjectIdentifier ; skos:prefLabel "01-701-1015" ; . cdiscpilot01:UniqueSubjectIdentifier_01-701-1023 rdf:type study:UniqueSubjectIdentifier ; skos:prefLabel "01-701-1023" ; . cdiscpilot01:UniqueSubjectIdentifier_01-701-1028 rdf:type study:UniqueSubjectIdentifier ; skos:prefLabel "01-701-1028" ; . cdiscpilot01:VisitBaselineActivity_01-701-1015 rdf:type owl:Class ; rdfs:subClassOf custom:VisitBaselineActivity ; skos:prefLabel "Visit Baseline Person 01-701-1015" ; . cdiscpilot01:VisitBaselineActivity_01-701-1023 rdf:type owl:Class ; rdfs:subClassOf custom:VisitBaselineActivity ; skos:prefLabel "Visit Baseline Person 01-701-1023" ; . cdiscpilot01:VisitBaselineActivity_01-701-1028 rdf:type owl:Class ; rdfs:subClassOf custom:VisitBaselineActivity ; skos:prefLabel "Visit Baseline Person 01-701-1028" ; . cdiscpilot01:VisitBaseline_01-701-1015 rdf:type custom:VisitBaseline ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1015_2014-01-02_2014-01-16 ; study:hasPerformedDate cdiscpilot01:Date_2014-01-02 ; . cdiscpilot01:VisitBaseline_01-701-1023 rdf:type custom:VisitBaseline ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1023_2012-08-05_2012-08-27 ; study:hasPerformedDate cdiscpilot01:Date_2012-08-05 ; . cdiscpilot01:VisitBaseline_01-701-1028 rdf:type custom:VisitBaseline ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1028_2013-07-19_2013-08-01 ; study:hasPerformedDate cdiscpilot01:Date_2013-07-19 ; . cdiscpilot01:VisitScreening1Activity_01-701-1015 rdf:type owl:Class ; rdfs:subClassOf custom:VisitScreening1Activity ; skos:prefLabel "Visit Screening 1 Person 01-701-1015" ; . cdiscpilot01:VisitScreening1Activity_01-701-1023 rdf:type owl:Class ; rdfs:subClassOf custom:VisitScreening1Activity ; . cdiscpilot01:VisitScreening1Activity_01-701-1028 rdf:type owl:Class ; rdfs:subClassOf custom:VisitScreening1Activity ; . cdiscpilot01:VisitScreening1_01-701-1015 rdf:type custom:VisitScreening1 ; study:activityStatus code:ActivityStatus_CO ; study:hasActivity cdiscpilot01:AssumeBodyPositionStanding_Screening1_01-701-1015 ; study:hasActivity cdiscpilot01:AssumeBodyPositionSupine_Screening1_01-701-1015 ; study:hasActivity cdiscpilot01:DiastolicBloodPressure_Screening1_01-701-1015_1 ; study:hasActivity cdiscpilot01:DiastolicBloodPressure_Screening1_01-701-1015_2 ; study:hasActivity cdiscpilot01:DiastolicBloodPressure_Screening1_01-701-1015_3 ; study:hasActivity cdiscpilot01:Height_Screening1_01-701-1015_43 ; study:hasActivity cdiscpilot01:Pulse_Screening1_01-701-1015_44 ; study:hasActivity cdiscpilot01:Pulse_Screening1_01-701-1015_45 ; study:hasActivity cdiscpilot01:Pulse_Screening1_01-701-1015_46 ; study:hasActivity cdiscpilot01:SystolicBloodPressure_Screening1_01-701-1015_86 ; study:hasActivity cdiscpilot01:SystolicBloodPressure_Screening1_01-701-1015_87 ; study:hasActivity cdiscpilot01:SystolicBloodPressure_Screening1_01-701-1015_88 ; study:hasActivity cdiscpilot01:Temperature_Screening1_01-701-1015_128 ; study:hasActivity cdiscpilot01:Weight_Screening1_01-701-1015_142 ; study:hasPerformedDate cdiscpilot01:Date_2013-12-26 ; . cdiscpilot01:VisitScreening1_01-701-1023 rdf:type custom:VisitScreening1 ; study:hasPerformedDate cdiscpilot01:Date_2012-07-22 ; . cdiscpilot01:VisitScreening1_01-701-1028 rdf:type custom:VisitScreening1 ; study:hasPerformedDate cdiscpilot01:Date_2013-07-11 ; . cdiscpilot01:VisitWk24Activity_01-701-1015 rdf:type owl:Class ; rdfs:subClassOf custom:VisitWk24Activity ; skos:prefLabel "Visit Week 24 Person 01-701-1015" ; . cdiscpilot01:VisitWk24Activity_01-701-1028 rdf:type owl:Class ; rdfs:subClassOf custom:VisitWk24Activity ; skos:prefLabel "Visit Week 24 Person 01-701-1028" ; . cdiscpilot01:VisitWk24_01-701-1015 rdf:type custom:VisitWk24 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1015_2014-06-19_2014-07-02 ; study:hasPerformedDate cdiscpilot01:Date_2014-06-18 ; . cdiscpilot01:VisitWk24_01-701-1028 rdf:type custom:VisitWk24 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1028_2014-01-07_2014-01-14 ; study:hasPerformedDate cdiscpilot01:Date_2014-01-06 ; . cdiscpilot01:VisitWk26_01-701-1015 rdf:type custom:VisitWk26 ; study:hasPerformedDate cdiscpilot01:Date_2014-07-02 ; . cdiscpilot01:VisitWk26_01-701-1028 rdf:type custom:VisitWk26 ; study:hasPerformedDate cdiscpilot01:Date_2014-01-14 ; . cdiscpilot01:VisitWk2Activity_01-701-1015 rdf:type owl:Class ; rdfs:subClassOf custom:VisitWk2Activity ; skos:prefLabel "Visit Week 2 Person 01-701-1015" ; . cdiscpilot01:VisitWk2Activity_01-701-1023 rdf:type owl:Class ; rdfs:subClassOf custom:VisitWk2Activity ; skos:prefLabel "Visit Week 2 Person 01-701-1023" ; . cdiscpilot01:VisitWk2Activity_01-701-1028 rdf:type owl:Class ; rdfs:subClassOf custom:VisitWk2Activity ; skos:prefLabel "Visit Week 2 Person 01-701-1028" ; . cdiscpilot01:VisitWk2_01-701-1015 rdf:type custom:VisitWk2 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1015_2014-01-17_2014-06-18 ; study:hasPerformedDate cdiscpilot01:Date_2014-01-16 ; . cdiscpilot01:VisitWk2_01-701-1023 rdf:type custom:VisitWk2 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1023_2012-08-28_2012-09-01 ; study:hasPerformedDate cdiscpilot01:Date_2012-08-27 ; . cdiscpilot01:VisitWk2_01-701-1028 rdf:type custom:VisitWk2 ; study:hasActivity cdiscpilot01:DrugAdministration_01-701-1028_2013-08-02_2014-01-06 ; study:hasPerformedDate cdiscpilot01:Date_2013-08-01 ; . cdiscpilot01:WeightOutcome_119_0 rdf:type study:WeightOutcome ; skos:prefLabel "119.0 LB" ; code:hasUnit code:Unit_LB ; code:hasValue "119.0"^^xsd:float ; . cdiscpilot01:Weight_Screening1_01-701-1015_142 rdf:type cd01p:VisitScreening1Weight ; rdf:type cdiscpilot01:VisitScreening1Activity_01-701-1015 ; rdf:type code:Weight ; code:outcome cdiscpilot01:WeightOutcome_119_0 ; study:activityStatus code:ActivityStatus_CO ; study:derivedFlag "N" ; study:groupID "GRPID1" ; study:hasCategory cd01p:Category_1 ; study:hasScheduledDate cdiscpilot01:Date_2013-12-26 ; study:hasSubcategory cd01p:Subcategory_1 ; study:reasonNotDone "not applicable" ; study:seq "142"^^xsd:float ; study:sponsordefinedID "5000" ; . meddra:PT10003041_AppSiteErythema meddra:hasHLT meddra:HLT10003057_AppReaction ; . sdtmterm:BlindedTreatment rdfs:subClassOf study:Epoch ; . sdtmterm:Screening rdf:type owl:Class ; rdfs:subClassOf study:Epoch ; .