: Public Class
Created: 12/14/2005 2:21:14 PM
Modified: 8/24/2012 2:32:55 PM
Project:
Advanced:
DEFINITION:<br /></p><p>The completed action of applying, introducing or otherwise giving medications or other substances to the subject or experimental unit.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>An experimental unit who receives methotrexate as part of chemotherapy, radiation therapy.<br /></p><p><br /></p><p>For a SubstanceAdministration, targetAnatomicSiteCode = coronary artery, approachAnatomicSiteCode = groin, routeOfAdministrationCode = intra-arterial.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public PQ
  productDose
Details:
Map:caAERSv2.2=Dose.unit
Map:caAERSv2.2=RadiationIntervention.dosage
Map:caAERSv2.2=RadiationIntervention.dosageUnit
Map:caAERSv2.2=Dose.amount
Map:caAERSv2.2=AdverseEventResponseDescription.reducedDose
Map:CDASHv1.1=EX.EXVOLTU
Map:CDASHv1.1=EX.EXVOLT
Map:CTOM=StudyParticipantAssignment.studyAgentDoseLevel
Map:CTOM=StudyParticipantAssignment.studyAgentDoseLevelUnitOfMeasureCode
Map:CTOM=Radiation.dose
Map:CTOM=SubstanceAdministration.singleDose
Map:CTOM=SubstanceAdministration.singleDoseUnitOfMeasureCode
Map:CTOM=Radiation.doseUnitOfMeasureCode
Map:CTRv1.0=PerformedSubstanceAdministration.productDose
Map:HCTv1.0=CDE 2729014:Therapies.For the allogeneic blood transfusion, specify the number of units:
Map:HCTv1.0=CDE 2180757:Therapies.RT Dose per Fraction
Map:HCTv1.0=CDE 2738560:Therapy Doses.Total volume of product plus additives infused:
Map:HCTv1.0=CDE 2954034:Therapy Doses.Dose per fraction unit of measure:
Map:HCTv1.0=CDE 2729000:Therapies.For the autologous blood transfusion, specify the number of units:
Map:HCTv1.0=CDE 2954032:Therapy Doses.Dose per fraction:
Map:HCTv1.0=CDE 3108427:Therapies.What is the dose value of the preparative regimen medication?
Map:LSDAM=PerformedSubstanceAdministration.dose
Map:NCI CRF Standard=CDE 2182728v2.0: Agent Dose
Map:NCI CRF Standard=CDE 3028750v1.0: Intervention Potency Unit of Measure for Unified Code for Units of Measure Code
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The quantity of a substance or medication used in a substance administration.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;5 mg#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;DefinedSubstanceAdministration.productDose can contain a dose expressed in absolute or relative terms (e.g., mg or mg/kg). ScheduledSubstanceAdministration.activeIngredientDose and PerformedSubstanceAdministration.productDose must contain a dose expressed in absolute terms (e.g., mg). If the DefinedSubstanceAdministration.productDose was expressed in relative terms (e.g., mg/kg), then the absolute dose must have been calculated using one or more observed factors as identified by the DefinedExpressionVariableRelationship.#lt;br /#gt;#lt;/p#gt;
Public ST
  productDoseDescription
Details:
Map:CTOM=SubstanceAdministration.descriptionText
Map:CTRv1.0=PerformedSubstanceAdministration.productDoseDescription
Map:LSDAM=PerformedSubstanceAdministration.doseDescription
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The textual representation of dosing amounts or a range of dosing information used in a substance administration.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;200-400#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;This is used for more complex dosages such as scaling and tapering doses, uncertain dosage ranges, differing morning and evening doses and other instructions that can't be expressed with a simple PQ.#lt;br /#gt;#lt;/p#gt;
Public PQ
  periodProductDoseTotal
Details:
Map:caAERSv2.2=Dose.amount
Map:caAERSv2.2=RadiationIntervention.fractionNumber
Map:caAERSv2.2=Dose.units
Map:CTOM=SubstanceAdministration.totalDose
Map:CTOM=SubstanceAdministration.totalDoseUnitOfMeasureCode
Map:CTRv1.0=PerformedSubstanceAdministration.periodProductDoseTotal
Map:HCTv1.0=CDE 2960642:Therapies.Specify craniospinal radiation total dose:
Map:HCTv1.0=CDE 2979333:Therapies.Local-regional radiation therapy total dose:
Map:HCTv1.0=CDE 2980940:Therapies.What was the radiation total dose?
Map:HCTv1.0=CDE 2964435:Therapies.Radiation therapy field radioactive instillation total dose
Map:HCTv1.0=CDE 3086792:Therapies.Specify total dose:
Map:HCTv1.0=CDE 2960770:Therapies.Specify the total radiation dose administered to another site:
Map:HCTv1.0=CDE 2960298:Therapies.What was the preparative regimen total milligram dose?
Map:HCTv1.0=CDE 2960635:Therapies.Specify local cranial radiation total dose:
Map:HCTv1.0=CDE 2960768:Therapies.Specify local spinal radiation total dose:
Map:HCTv1.0=CDE 2962200:Therapies.Specify interstitial irradiation/brachytherapy total dose:
Map:HCTv1.0=CDE 2721441:Therapies.Total Dose
Map:HCTv1.0=CDE 2960649:Therapies.Specify gamma knife and/or radiosurgery radiation total dose:
Map:HCTv1.0=CDE 2953815:Therapies.Total dose unit of measure:
Map:HCTv1.0=CDE 3181110:Therapies.Therapeutic procedure administered milligram daily dose:
Map:HCTv1.0=CDE 2960618:Therapies.Specify whole brain radiation total dose:
Map:LSDAM=PerformedSubstanceAdministration.periodDoseTotal
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The total of all doses of treatment in a given period of time.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The given period of time is defined in dosePeriodCode.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;This attribute, periodProductDoseTotal, is not necessarily derivable since the dose may be provided as a string (in productDoseDescription).#lt;br /#gt;#lt;/p#gt;
Public CD
  dosePeriodCode
Details:
Map:caAERSv2.2=CourseAgent>totalDoseAdministeredThisCourse>Dose
Map:CTRv1.0=PerformedSubstanceAdministration.dosePeriodCode
Map:HCTv1.0=CDE 2635420:Therapy Doses.Was the radiation therapy fractionated
Map:LSDAM=PerformedSubstanceAdministration.dosePeriodCode
Notes: DEFINITION: #lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the period during which the dose total is administered. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;daily, course#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The dose total is defined in periodProductDoseTotal and/or periodActiveIngredientDoseTotal.#lt;br /#gt;#lt;/p#gt;
Public PQ
  periodActiveIngredientDoseTotal
Details:
Map:caAERSv2.2=RadiationIntervention.fractionNumber
Map:caAERSv2.2=Dose.units
Map:caAERSv2.2=Dose.amount
Map:CDASHv1.1=CM.CMDOSTOT
Map:CTOM=SubstanceAdministration.totalDoseUnitOfMeasureCode
Map:CTOM=SubstanceAdministration.totalDose
Map:CTRv1.0=PerformedSubstanceAdministration.periodActiveIngredientDoseTotal
Map:SDTM IGv3.1.1=EX.EXDOSTOT
Map:SDTM IGv3.1.1=SU.SUDOSTOT
Map:SDTM IGv3.1.1=CM.CMDOSTOT
Map:SDTM IGv3.1.2=CM.CMDOSTOT
Map:SDTM IGv3.1.2=SU.SUDOSTOT
Map:SDTM IGv3.1.2=EX.EXDOSTOT
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The total amount of active ingredient in all doses of treatment in a given period of time.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The given period of time is defined in dosePeriodCode.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived by multiplying PerformedSubstanceAdministration.periodProductDoseTotal (the composite product that was administered) with the ProductRelationship.quantity (a ratio) for the component product that is the active ingredient (where ProductRelationship.activeIngredientIndicator = "true").#lt;br /#gt;#lt;/p#gt;
Public PQ
  activeIngredientDose
Details:
Map:caAERSv2.2=AdverseEventResponseDescription.reducedDose
Map:caAERSv2.2=RadiationIntervention.dosageUnit
Map:caAERSv2.2=RadiationIntervention.dosage
Map:caAERSv2.2=Dose.amount
Map:caAERSv2.2=Dose.unit
Map:CDASHv1.1=EX.EXDSTXT
Map:CDASHv1.1=SU.SUDOSU
Map:CDASHv1.1=CM.CMDOSU
Map:CDASHv1.1=EX.EXDOSU
Map:CTOM=StudyParticipantAssignment.studyAgentDoseLevel
Map:CTOM=SubstanceAdministration.singleDoseUnitOfMeasureCode
Map:CTOM=SubstanceAdministration.singleDose
Map:CTOM=StudyParticipantAssignment.studyAgentDoseLevelUnitOfMeasureCode
Map:CTRv1.0=PerformedSubstanceAdministration.activeIngredientDose
Map:SDTM IGv3.1.1=EX.EXDOSE
Map:SDTM IGv3.1.1=CM.CMDOSU
Map:SDTM IGv3.1.1=EX.EXDOSU
Map:SDTM IGv3.1.1=CM.CMDOSE
Map:SDTM IGv3.1.1=SU.SUDOSE
Map:SDTM IGv3.1.1=SU.SUDOSU
Map:SDTM IGv3.1.2=SU.SUDOSE
Map:SDTM IGv3.1.2=CM.CMDOSE
Map:SDTM IGv3.1.2=EX.EXDOSU
Map:SDTM IGv3.1.2=EX.EXDOSE
Map:SDTM IGv3.1.2=CM.CMDOSU
Map:SDTM IGv3.1.2=SU.SUDOSU
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The quantity of active ingredients used in a substance administration.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;5 mg#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived by multiplying the PerformedSubstanceAdministration.productDose (the composite product that was administered) with the ProductRelationship.quantity (a ratio) for the component product that is the active ingredient (where ProductRelationship.activeIngredientIndicator = "true").#lt;br /#gt;#lt;/p#gt;
Public ST
  activeIngredientDoseDescription
Details:
Map:CDASHv1.1=SU.SUDSTXT
Map:CDASHv1.1=EX.EXDSTXT
Map:CDASHv1.1=CM.CMDSTXT
Map:CTOM=SubstanceAdministration.descriptionText
Map:CTRv1.0=PerformedSubstanceAdministration.activeIngredientDoseDescription
Map:SDTM IGv3.1.1=SU.SUDOSTXT
Map:SDTM IGv3.1.1=CM.CMDOSTXT
Map:SDTM IGv3.1.1=EX.EXDOSTXT
Map:SDTM IGv3.1.2=SU.SUDOSTXT
Map:SDTM IGv3.1.2=CM.CMDOSTXT
Map:SDTM IGv3.1.2=EX.EXDOSTXT
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The textual representation of active ingredients in the dosing amounts or a range of dosing information used in a substance administration.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;200-400#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;This is used for more complex dosages such as scaling and tapering doses, uncertain dosage ranges, differing morning and evening doses and other instructions that can't be expressed with a simple PQ.#lt;br /#gt;#lt;/p#gt;
Public PQ
  treatmentVehicleQuantity
Details:
Map:CTRPv1.0=SubstanceAdministration.treatmentVehicleVolume
Map:LSDAM=PerformedSubstanceAdministration.treatmentVehicleVolume
Map:NCI CRF Standard=CDE 2871633v1.0: Agent Administration Drug Vehicle Total Volume Number
Map:SDTM IGv3.1.2=EX.EXVAMT
Map:SDTM IGv3.1.2=EX.EXVAMTU
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The quantity and units of treatment vehicle used.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;10 milligrams, 2 milliliters#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived by multiplying the#lt;br /#gt;#lt;/p#gt;#lt;p#gt;PerformedSubstancedAdministration.productDose (the composite product that was administered) with the ProductRelationship.quantity#lt;br /#gt;#lt;/p#gt;#lt;p#gt;(a ratio) for the component product that is the active ingredient (where ProductRelationship.activeIngredientIndicator = "false").#lt;br /#gt;#lt;/p#gt;
Public INT.POS
  distinctProductCount
Details:
Map:HCTv1.0=CDE 3010760:DONOR'.What is the number of hematopoietic stem cell products that resulted from different collection methods or episodes and or mobilization techniques?
Map:HCTv1.0=CDE 2693395:Procedures.Were multiple products infused?
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The number of products (resulting from different collections) used for this substance administration. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;If blood is taken from 2 people (two donations from one of them), this would be counted as 3 different collections.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;This is a count of distinct donations, typically used for stem cell transplants.#lt;br /#gt;#lt;/p#gt;
Public CD
  doseFrequencyCode
Details:
Map:caAERSv2.2=CourseAgent.durationAndSchedule
Map:CDASHv1.1=CM.CMDOSFRQ
Map:CDASHv1.1=EX.EXDOSFRQ
Map:CDASHv1.1=SU.SUDOSFRQ
Map:CTOM=SubstanceAdministration.doseFrequencyText
Map:CTOM=SubstanceAdministration.doseFrequencyCode
Map:CTRv1.0=PerformedSubstanceAdministration.doseFrequencyCode
Map:LSDAM=PerformedSubstanceAdministration.doseFrequencyCode
Map:NCI CRF Standard=CDE 2003322v4.0: Administration Schedule Term Name
Map:SDTM IGv3.1.1=EX.EXDOSFRQ
Map:SDTM IGv3.1.1=CM.CMDOSFRQ
Map:SDTM IGv3.1.1=SU.SUDOSFRQ
Map:SDTM IGv3.1.2=CM.CMDOSFRQ
Map:SDTM IGv3.1.2=EX.EXDOSFRQ
Map:SDTM IGv3.1.2=SU.SUDOSFRQ
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying how often doses are administered. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;BID, TID, QID#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;This attribute is needed in order to capture multiple substance administrations in one act, rather than each time a patient swallows a pill, for example "The patient took med X 3 times a day for 10 days starting on June 9th". #lt;br /#gt;#lt;/p#gt;
Public RTO<PQ,PQ.TIME>
  flowRate
Details:
Map:CDASHv1.1=EX.EXFLRT
Map:CDASHv1.1=EX.EXFLRTU
Map:CTRv1.0=PerformedSubstanceAdministration.flowRate
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/SubstanceAdministration.rateQuantity
Map:NCI CRF Standard=CDE 2475888v1.0: Infusion Flow Rate Number
Notes: DEFINITION: #lt;br /#gt;#lt;/p#gt;#lt;p#gt;A ratio specifying the speed with which the substance is introduced into the subject. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;100 mL/h#lt;br /#gt;#lt;/p#gt;#lt;p#gt;1 g/d#lt;br /#gt;#lt;/p#gt;#lt;p#gt;40 mmol/h#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  routeOfAdministrationCode
Details:
Map:caAERSv2.2=Dose.route
Map:CDASHv1.1=CM.CMROUTE
Map:CDASHv1.1=EX.EXROUTE
Map:CTOM=SubstanceAdministration.routeCode
Map:CTRv1.0=PerformedSubstanceAdministration.routeOfAdministrationCode
Map:HCTv1.0=CDE 2960396:Therapies.What was the route of administration for the preparative regimen drugs?
Map:HCTv1.0=CDE 2780200:Therapy Doses.Specify route of infusion:
Map:HCTv1.0=CDE 2698088:Therapy Doses.Specify the route of product infusion:
Map:HCTv1.0=MD Anderson Specific Content: Transplant.Intravenous administration
Map:LSDAM=PerformedSubstanceAdministration.routeOfAdministrationCode
Map:NCI CRF Standard=CDE 2003586v6.0: Access Route of Administration Text Code
Map:SDTM IGv3.1.1=CM.CMROUTE
Map:SDTM IGv3.1.1=EX.EXROUTE
Map:SDTM IGv3.1.1=SU.SUROUTE
Map:SDTM IGv3.1.2=EX.EXROUTE
Map:SDTM IGv3.1.2=SU.SUROUTE
Map:SDTM IGv3.1.2=CM.CMROUTE
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the physiological path or method of introducing the substance into or onto the subject. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;oral, intravenous, swallow, oral rinse, oral topical application, chew, oral dissolve, oral inhalation#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Route is more than just approach site.  It deals with how the body will actually absorb/receive the drug.  The approach site might be "mouth", but from a route code perspective, this could include: swallow, oral rinse, oral topical application, chew, oral dissolve, oral inhalation (via intermittent flow or rebreather mask).  The effect of the drug could vary depending on the route even if the body site happens to be the same.#lt;br /#gt;#lt;/p#gt;
Public PQ.TIME
  interruptionDuration
Details:
Map:CDASHv1.1=EX.EXINTRPU
Map:CDASHv1.1=EX.EXINTRP
Map:CTRv1.0=PerformedSubstanceAdministration.interruptionDuration
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The period of time during which a substance administration is interrupted. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An infusion started at 12:15pm and ended at 2:37pm, but there was an interruption of 17 minutes.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  changeTypeCode
Details:
Map:caAERSv2.2=CourseAgent.agentAdjustment
Map:CTOM=SubstanceAdministration.doseChangeCode
Map:CTRv1.0=PerformedSubstanceAdministration.changeTypeCode
Map:LSDAM=PerformedSubstanceAdministration.changeTypeCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the modification of the substance administration in relation to the previous substance administration. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Agent Added, Agent Dose Decreased, Agent Dose Increased#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public BL
  plannedChangeIndicator
Details:
Map:CTOM=SubstanceAdministration.doseChangeIndicatorCode
Map:CTOM=DiseaseResponse.doseChangeIndicatorCode
Map:CTRv1.0=PerformedSubstanceAdministration.plannedChangeIndicator
Map:LSDAM=PerformedSubstanceAdministration.plannedChangeIndicator
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether a change in the substance administration in relation to the previous substance administration is planned or not.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;True = planned, False = unplanned#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public ST
  changeReason
Details:
Map:CDASHv1.1=EX.EXADJ
Map:CTRv1.0=PerformedSubstanceAdministration.changeReason
Map:LSDAM=PerformedSubstanceAdministration.changeReason
Map:SDTM IGv3.1.1=EX.EXADJ
Map:SDTM IGv3.1.2=EX.EXADJ
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The rationale for changing the substance administration in relation to the previous substance administration.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Dose reduced due to hematologic toxicity#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public BL
  substanceUnknownIndicator
Details:
Map:HCTv1.0=CDE 2974124:Therapies.What is the reason for the drug induced drug missing value?
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether the substance administered was not known.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public BL
  standardTimeIndicator
Details:
Map:HCTv1.0=CDE 2713223:Occurrences.Is it the standard time or daylight savings time?
Map:HCTv1.0=CDE 2713225:Occurrences.Is it the standard time or daylight savings time?
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether the time of the substance administration is specified using standard (as opposed to daylight savings) time.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;If the location and date are known, this data is derivable.#lt;br /#gt;#lt;/p#gt;
Public CD
  startRelativeToReferenceCode
Details:
Map:CTRv1.0=PerformedSubstanceAdministration.startRelativeToReferenceCode
Map:LSDAM=PerformedSubstanceAdministration.startRelativeToReferenceCode
Map:SDTM IGv3.1.1=CM.CMSTRF
Map:SDTM IGv3.1.1=SU.SUSTRF
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying when this event started with respect to the sponsor-defined reference period.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Medications that are ongoing at the end of the reference period should have a value of "during/after" for this variable.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Before, during, during/after, after#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from comparing PerformedSubstanceAdministration.dateRange(IVL#lt;TS.DATETIME).low and PerformedStudySubjectMilestone.studyReferenceDateRange.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Sponsors should define the reference period in the study metadata.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;This may be populated when a start date is not collected.#lt;br /#gt;#lt;/p#gt;
Public CD
  endRelativeToReferenceCode
Details:
Map:CTRv1.0=PerformedSubstanceAdministration.endRelativeToReferenceCode
Map:LSDAM=PerformedSubstanceAdministration.endRelativeToReferenceCode
Map:SDTM IGv3.1.1=CM.CMENRF
Map:SDTM IGv3.1.1=SU.SUENRF
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying when this event ended with respect to the sponsor-defined reference period.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;before, during, during/after, after#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from comparing PerformedSubstanceAdministration.dateRange(IVL#lt;TS.DATETIME#gt;).high and PerformedStudySubjectMilestone.studyReferenceDateRange.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Sponsors should define the reference period in the study metadata.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;This may be populated when a start date is not collected.#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
PerformedMedicalConditionResult
Class   		Name: addressingPerformedSubstanceAdministration
  		Name: addressedPerformedMedicalConditionResult
 
Details:
DESCRIPTION:<br /></p><p>Each PerformedSubstanceAdministration might address one or more PerformedMedicalConditionResult. Each PerformedMedicalConditionResult might be addressed by one or more PerformedSubstanceAdministration.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
PerformedActivity
Class   		Name: endEvaluatedPerformedSubstanceAdministration
  		Name: endRelatedPerformedActivity
 
Details:
DESCRIPTION:<br /></p><p>Each PerformedSubstanceAdministration might have end evaluated in relation to one PerformedActivity. Each PerformedActivity might be the timepoint for evaluating the end of one or more PerformedSubstanceAdministration.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>In CDISC SDTM, CMENTPT indicates a study event that may be a reference event for the end of a concomitant medication (PerformedSubstanceAdministration) or SUENTPT might be the reference event for the end of a substance use event (also a PerformedSubstanceAdministration).<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>As per CDISC, any given substance administration can have its start evaluated in relation to a performed activity. Likewise it can also have its end evaluated in relation to a performed activity.  The two performed activities need not necessarily be the same in both cases, thus there are two distinct associations between PerformeSubstanceAdministration and PerformedActivity for evaluating start and end of the administration.<br /></p>
PerformedActivity
Class   		Name: startEvaluatedPerformedSubstanceAdministration
  		Name: startRelatedPerformedActivity
 
Details:
DESCRIPTION:<br /></p><p>Each PerformedSubstanceAdministration might have start evaluated in relation to one PerformedActivity. Each PerformedActivity might be the timepoint for evaluating the start of one or more PerformedSubstanceAdministration.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>In CDISC SDTM, CMSTTPT indicates a study event that may be a reference event for the start of a concomitant medication (PerformedSubstanceAdministration) or SUENTPT might be the reference event for the start of a substance use event (also a PerformedSubstanceAdministration.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>As per CDISC, any given substance administration can have its start evaluated in relation to a performed activity. Likewise it can also have its end evaluated in relation to a performed activity.  The two performed activities need not necessarily be the same in both cases, thus there are two distinct associations between PerformeSubstanceAdministration and PerformedActivity for evaluating start and end of the administration.<br /></p>
Element Source Role Target Role
SubstanceExtractionAdministrationRelationship
Class   		Name: producedSubstanceExtractionAdministrationRelationship
  		Name: usingPerformedSubstanceAdministration
 
Details:
DESCRIPTION:<br /></p><p>Each SubstanceExtractionAdministrationRelationship might be producing a substance later used in one PerformedSubstanceAdministration.  Each PerformedSubstanceAdministration might be using a substance produced by one or more SubstanceExtractionAdministrationRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Tag Value
Map:AE Intervention
Details:
 
Map:caAERSv2.2 StudyParticipantPriorTherapy
Details:
 
Map:caAERSv2.2 StudyParticipantConcomitantMedication
Details:
 
Map:CTRv1.0 PerformedSubstanceAdministration
Details:
 
Map:HCTv1.0 CDE 2934704:Therapies.Were tyrosine kinase inhibitors administered?
Details:
 
Map:HCTv1.0 CDE 3040303:Therapies.Was another radioisotope administered?
Details:
 
Map:LSDAM PerformedSubstanceAdministration
Details:
 
Map:LSDAMv2.2.3Plus PerformedSubstanceAdministration
Details:
 
Map:SDTM IGv3.1.2 SU.DOMAIN
Details:
 
Map:SDTM IGv3.1.2 EX.DOMAIN
Details:
 
Map:SDTM IGv3.1.2 CM.DOMAIN
Details:
 
Map:SDTMIGv3.1.3 SU
Details:
 
Map:SDTMIGv3.1.3 EX
Details:
 
Map:SDTMIGv3.1.3 CM
Details:
 
Constraint Type Status
be participated in by Qualifier Invariant Approved
Details:
Associations from Subject (including StudySubject) are valid only for BiologicEntity, BiologicEntityGroup and Specimen, not for Product, HealthcareFacility or Organization. Associations from ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, but not for Product or ProductGroup.
relativeToReference Qualifier Invariant Approved
Details:
endRelativeToReference must not logically precede the startRelativeToReference. For example, if startRelativeToReference is "during", endRelativeToReference must not be "before".
Active Ingredient Qualifier Invariant Approved
Details:
activeIngredientDose, periodActiveIngredientDoseTotal must only be used when the PerformedSubstanceAdministration is associated to a StudyAgent that has only one active ingredient. Otherwise, it would be ambiguous to which active ingredient the amounts indicated in these attributes apply.
Dose Qualifier Invariant Approved
Details:
productDose, periodProductDoseTotal, treatmentVehicleAmount, activeIngredientDose, periodActiveIngredientDoseTotal must only be used when the PerformedSubstanceAdministration is associated to a single StudyAgent. Otherwise, it would be ambiguous to which agent the amounts indicated in these attributes apply.
substanceUnknownIndicator Qualifier Invariant Approved
Details:
PerformedSubstanceAdministration.substanceUnknownIndicator must = "false" if an association from this procedure to a product exists.
Object Type Connection Direction Notes
PerformedProcedure Class Generalization To DESCRIPTION: Each PerformedSubstanceAdministration always specializes one PerformedProcedure. Each PerformedProcedure might be specialized by one PerformedSubstanceAdministration. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):