CDASH Terminology 2011-07-22.pdf - EVS

CDISC Controlled Terminology CDASH - 2011-07-22NCICodeCDISCSubmissionValue Codelist Name CDISC DefinitionCodelistExtensibleC78418 CMDOSFRM Concomitant Medication DoseFormC78419 CMDOSFRQ Concomitant MedicationDosing Frequency per IntervalC78417 CMDOSU Concomitant Medication DoseUnitsC78420 CMROUTE Concomitant MedicationRoute of AdministrationC78421 DAORRESU Unit of Drug Dispensed orReturnedA terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelistcreated for CDASH Concomitant Medication Dose Form codelist. (NCI)A terminology subset of the CDISC SDTM Frequency codelist created for CDASHConcomitant Medication Dosing Frequency per Interval codelist. (NCI)A terminology subset of the CDISC SDTM Unit codelist created for CDASHConcomitant Medication Dose Units codelist. (NCI)A terminology subset of the CDISC SDTM Route codelist created for CDASHConcomitant Medication Route of Administration codelist. (NCI)A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit ofDrug Dispensed or Returned codelist. (NCI)YesYesYesYesYesC78422 EGORRESU ECG Original Units A terminology subset of the CDISC SDTM Unit codelist created for CDASH ECGOriginal Units codelist. (NCI)C78426 EXDOSFRM Exposure Dose Form A terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelistcreated for CDASH Exposure Dose Form codelist. (NCI)YesYesC78745 EXDOSFRQ Exposure Dosing Frequencyper IntervalA terminology subset of the CDISC SDTM Frequency codelist created for CDASHExposure Dosing Frequency per Interval codelist. (NCI)YesC78423 EXDOSU Units for Exposure A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unitsfor Exposure codelist. (NCI)C78429 EXFLRTU Unit of Measure for Flow Rate A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit ofMeasure for Flow Rate codelist. (NCI)YesYesC78427 EXINTPU Unit for the Duration ofTreatment InterruptionA terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit forDuration of Treatment Interruption codelist. (NCI)YesC78430 EXPDOSEU Units for Planned Exposure A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unitsfor Planned Exposure codelist. (NCI)YesC78425 EXROUTE Exposure Route ofAdministrationC78428 EXVOLTU Total Volume AdministrationUnitC83004 SUNCF Substance UseNever/Current/FormerClassificationA terminology subset of the CDISC SDTM Route codelist created for CDASHExposure Route of Administration codelist. (NCI)A terminology subset of the CDISC SDTM Unit codelist created for CDASH TotalVolume Administration Unit codelist. (NCI)A terminology subset of the CDISC SDTM Never/Current/Former Classificationcodelist created for CDASH Substance Use Never/Current/Former Classificationcodelist. (NCI)YesYesYesC78431 VSPOS Vital Signs Position of Subject A terminology subset of the CDISC SDTM Position codelist created for CDASH VitalSigns Position of Subject codelist. (NCI)YesSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 1 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78418 - CMDOSFRM - Concomitant Medication Dose FormCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC42887 AEROSOL aer A product that is packaged under pressure and containstherapeutically active ingredients that are releasedupon activation of an appropriate valve system; it isintended for topical application to the skin as well aslocal application into the nose (nasal aerosols), mouth(lingual aerosols), or lungs (inhalation aerosols).(NCI)C25158 CAPSULE cap A solid pharmaceutical dosage form that containsmedicinal agent within either a hard or soft solublecontainer or shell, usually used for the oraladministration of medicine. The shells are made of asuitable form of gelatin or other substance. (NCI)C28944 CREAM A semisolid emulsion of either the oil-in-water or thewater-in-oil type, ordinarily intended for topical use.(NCI)C42933 GAS Any elastic aeriform fluid in which the molecules areseparated from one another and have free paths. (NCI)C42934 GEL A semisolid (1) dosage form that contains a gellingagent to provide stiffness to a solution or a colloidaldispersion (2). A gel may contain suspended particles.Note 1: A semisolid is not pourable; it does not flowor conform to its container at room temperature. Itdoes not flow at low shear stress and generally exhibitsplastic flow behavior. Note 2: A colloidal dispersion isa system in which particles of colloidal dimension(i.e., typically between 1 nm and 1 micrometer) aredistributed uniformly throughout a liquid. (NCI)C42966 OINTMENT oint A suspension or emulsion, semisolid (1) dosage form,usually containing < 20% water and volatiles (2)and > 50% hydrocarbons, waxes, or polyols as thevehicle. This dosage form is generally for externalapplication to the skin or mucous membranes. Note 1:A semisolid is not pourable; it does not flow orconform to its container at room temperature. It doesnot flow at low shear stress and generally exhibitsplastic flow behavior. Note 2: Percent water andvolatiles are measured by a loss on drying test in whichthe sample is heated at 105 degrees C until constantweight is achieved. (NCI)C42968 PATCH A drug delivery system that often contains an adhesivebacking that is usually applied to an external site on thebody. Its ingredients either passively diffuse from, orare actively transported from, some portion of thepatch. Depending upon the patch, the ingredients areeither delivered to the outer surface of the body orinto the body. A patch is sometimes synonymous withthe terms Extended Release Film and System. (NCI)C42972 POWDER An intimate mixture of dry, finely divided drugs and/orchemicals that may be intended for internal or externaluse. (NCI)C42989 SPRAY A liquid minutely divided as by a jet of air or steam.(NCI)C42993 SUPPOSITORY supp A solid body of various weights and shapes, adapted forintroduction into the rectal orifice of the human body;they usually melt, soften, or dissolve at bodytemperature. (NCI)Aerosol Dosage FormCapsule Dosage FormCream Dosage FormGas Dosage FormGel Dosage FormOintment Dosage FormPatch Dosage FormPowder Dosage FormSpray Dosage FormSuppository Dosage FormSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 2 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78418 - CMDOSFRM - Concomitant Medication Dose FormCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC42994 SUSPENSION susp A liquid dosage form that contains solid particlesdispersed in a liquid vehicle. Note: A liquid ispourable; it flows and conforms to its container atroom temperature. It displays Newtonian orpseudoplastic flow behavior. (FDA)C42998 TABLET tab A solid dosage form containing medicinal substanceswith or without suitable diluents. (NCI)Suspension Dosage FormTablet Dosage FormSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 3 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78419 - CMDOSFRQ - Concomitant Medication Dosing Frequency per IntervalCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC64496 BID Twice per day;BDTwo times per day, at unspecified times. (NCI)Twice DailyC64499 PRN As Needed As needed. (NCI) As NecessaryC25473 QD Daily Occurring or done each day. (NCI) DailyC64530 QID 4 times per day Four times per day. (NCI) Four Times DailyC64498 QM Every Month Every month. (NCI) MonthlyC64525 QOD Every other day Every other day. (NCI) Every Other DayC64527 TID 3 times per day Three times per day. (NCI) Three Times DailyC17998 UNKNOWN U; Unknown Not known, not observed, not recorded, or refused.(NCI)UnknownSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 4 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78417 - CMDOSU - Concomitant Medication Dose UnitsCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC48480 CAPSULE Capsule DosingUnit; capC48579 IU InternationalUnitA dosing measurement based on the capsule unit.(NCI)The unitage assigned by the WHO (World HealthOrganization) to International BiologicalStandards - substances, classed as biological accordingto the criteria provided by WHO Expert Committee onBiological Standardization (e.g. hormones, enzymes,and vaccines), to enable the results of biological andimmunological assay procedures to be expressed inthe same way throughout the world. The definition ofan international unit is generally arbitrary andtechnical, and has to be officially approved by theInternational Conference for Unification ofFormulae.(NCI)Capsule Dosing UnitInternational UnitC65060 PUFF Puff A means of delivering a defined dose of a therapeuticaerolized solution into either the upper or lowerrespiratory tract. Metered-dose inhalers or spraypumps are devices that provide a puff dose for deliveryinto either the oral or the nasal cavity.(NCI)Puff Dosing UnitC48542 TABLET Tablet DosingUnit; tabA dosing measurement based on the tablet unit.(NCI)Tablet Dosing UnitC48155 g Gram A metric unit of mass equal to one one thousandth of akilogram. (NCI)C28254 mL cm3; Milliliter The unit of volume equal to one thousandth of a liter,one cubic centimeter, 10E-6 cubic meter, orapproximately to 0.061 023 7 cubic inch.(NCI)C28253 mg Milligram The unit of mass equal to one thousandth of a gram or1000 micrograms. One milligram equalsapproximately 0.015432 grain or 35.274 x 10E-6ounce.(NCI)C48152 ug Microgram; mcg A unit of mass equal to one millionth of a gram or onethousandth of a milligram.(NCI)GramMilliliterMilligramMicrogramSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 5 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78420 - CMROUTE - Concomitant Medication Route of AdministrationCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC38250 INTRALESIONAL Administration within or introduced directly into alocalized lesion.(FDA)Intralesional Route of DrugAdministrationC28161 INTRAMUSCULAR Administration within a muscle.(FDA) Intramuscular Route ofAdministrationC38255 INTRAOCULAR Administration within the eye.(FDA) Intraocular Route of DrugAdministrationC38258 INTRAPERITEONEAL Administration within the peritoneal cavity.(FDA) Intraperitoneal Route of DrugAdministrationC38284 NASAL Administration to the nose; administered by way of thenose.(FDA)Nasal Route of Drug AdministrationC38288 ORAL PO Administration to or by way of the mouth.(FDA) Oral Route of Drug administrationC38295 RECTAL Administration to the rectum.(FDA) Rectal Route of Drug AdministrationC38216RESPIRATORY(INHALATION)Administration within the respiratory tract by inhalingorally or nasally for local or systemic effect.(FDA)Inhalation Route of AdministrationC38299 SUBCUTANEOUS SC Administration beneath the skin; hypodermic.Synonymous with the term SUBDERMAL.(FDA)C38304 TOPICAL TOP Administration to a particular spot on the outer surfaceof the body. The E2B term TRANSMAMMARY is asubset of the term TOPICAL.(FDA)C38305 TRANSDERMAL Administration through the dermal layer of the skin tothe systemic circulation by diffusion.(FDA)Subcutaneous Route of DrugAdministrationTopical Route of DrugAdministrationTransdermal Route of DrugAdministrationC38313 VAGINAL Administration into the vagina.(FDA) Vaginal Route of DrugAdministrationSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 6 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78421 - DAORRESU - Unit of Drug Dispensed or ReturnedCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC48474 BAG Bag Dosing Unit A dosing measurement based on the bag unit.(NCI) Bag Dosing UnitC48477 BOTTLE Bottle DosingUnitA dosing measurement based on the bottle unit.(NCI)Bottle Dosing UnitC48478 BOX Box Dosing Unit A dosing measurement based on the box unit.(NCI) Box Dosing UnitC48480 CAPSULE Capsule DosingUnit; capC48484 CONTAINER ContainerDosing UnitA dosing measurement based on the capsule unit.(NCI)A dosing measurement based on the containerunit.(NCI)Capsule Dosing UnitContainer Dosing UnitC48490 DISK Disk Dosing Unit A dosing measurement based on the disk unit.(NCI) Disk Dosing UnitC48520 PACKAGE Pack DosingUnit; PackageDosing UnitC48521 PACKET Packet DosingUnitC48524 PATCH Patch DosingUnitC48542 TABLET Tablet DosingUnit; tabC48549 TUBE Tube DosingUnitA dosing measurement based on the packageunit.(NCI)A dosing measurement based on the packet unit.(NCI)A dosing measurement based on the patch unit.(NCI)A dosing measurement based on the tablet unit.(NCI)A dosing measurement based on the tube unit.(NCI)Package Dosing UnitPacket Dosing UnitPatch Dosing UnitTablet Dosing UnitTube Dosing UnitC48551 VIAL Vial Dosing Unit A dosing measurement based on the vial unit.(NCI) Vial Dosing UnitSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 7 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78422 - EGORRESU - ECG Original UnitsCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC49673 BEATS/MIN Beats per Minute The number of heartbeats measured per minute time.(NCI)C41140 msec Millisecond A unit of time, which is equal to one thousandth of asecond.(NCI)C42535 sec Second The second is a unit of time with a duration of 919 263177 0 periods of the specified light radiationcorresponding to the transition between the twohyperfine levels of the cesium 133 atom in its groundstate at 0 K. According to the convention, 60 secondsconstitute one minute; 3,600 seconds constitute onehour. Abbreviation Sec. is acceptable in non-scientificusage only.(NCI)Beats per MinuteMillisecondSecondSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 8 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78426 - EXDOSFRM - Exposure Dose FormCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC42887 AEROSOL aer A product that is packaged under pressure and containstherapeutically active ingredients that are releasedupon activation of an appropriate valve system; it isintended for topical application to the skin as well aslocal application into the nose (nasal aerosols), mouth(lingual aerosols), or lungs (inhalation aerosols).(NCI)C25158 CAPSULE cap A solid pharmaceutical dosage form that containsmedicinal agent within either a hard or soft solublecontainer or shell, usually used for the oraladministration of medicine. The shells are made of asuitable form of gelatin or other substance. (NCI)C28944 CREAM A semisolid emulsion of either the oil-in-water or thewater-in-oil type, ordinarily intended for topical use.(NCI)C42933 GAS Any elastic aeriform fluid in which the molecules areseparated from one another and have free paths. (NCI)C42934 GEL A semisolid (1) dosage form that contains a gellingagent to provide stiffness to a solution or a colloidaldispersion (2). A gel may contain suspended particles.Note 1: A semisolid is not pourable; it does not flowor conform to its container at room temperature. Itdoes not flow at low shear stress and generally exhibitsplastic flow behavior. Note 2: A colloidal dispersion isa system in which particles of colloidal dimension(i.e., typically between 1 nm and 1 micrometer) aredistributed uniformly throughout a liquid. (NCI)C42966 OINTMENT oint A suspension or emulsion, semisolid (1) dosage form,usually containing < 20% water and volatiles (2)and > 50% hydrocarbons, waxes, or polyols as thevehicle. This dosage form is generally for externalapplication to the skin or mucous membranes. Note 1:A semisolid is not pourable; it does not flow orconform to its container at room temperature. It doesnot flow at low shear stress and generally exhibitsplastic flow behavior. Note 2: Percent water andvolatiles are measured by a loss on drying test in whichthe sample is heated at 105 degrees C until constantweight is achieved. (NCI)C42968 PATCH A drug delivery system that often contains an adhesivebacking that is usually applied to an external site on thebody. Its ingredients either passively diffuse from, orare actively transported from, some portion of thepatch. Depending upon the patch, the ingredients areeither delivered to the outer surface of the body orinto the body. A patch is sometimes synonymous withthe terms Extended Release Film and System. (NCI)C42972 POWDER An intimate mixture of dry, finely divided drugs and/orchemicals that may be intended for internal or externaluse. (NCI)C42989 SPRAY A liquid minutely divided as by a jet of air or steam.(NCI)C42993 SUPPOSITORY supp A solid body of various weights and shapes, adapted forintroduction into the rectal orifice of the human body;they usually melt, soften, or dissolve at bodytemperature. (NCI)Aerosol Dosage FormCapsule Dosage FormCream Dosage FormGas Dosage FormGel Dosage FormOintment Dosage FormPatch Dosage FormPowder Dosage FormSpray Dosage FormSuppository Dosage FormSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 9 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78745 - EXDOSFRQ - Exposure Dosing Frequency per IntervalCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC64496 BID BD; Twice perDayTwo times per day, at unspecified times. (NCI)Twice DailyC64499 PRN As Needed As needed. (NCI) As NecessaryC25473 QD Daily Occurring or done each day. (NCI) DailyC64530 QID 4 times per day Four times per day. (NCI) Four Times DailyC64498 QM Every Month Every month. (NCI) MonthlyC64525 QOD Every other day Every other day. (NCI) Every Other DayC64527 TID 3 times per day Three times per day. (NCI) Three Times DailyC17998 UNKNOWN U; Unknown Not known, not observed, not recorded, or refused.(NCI)UnknownSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 11 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78423 - EXDOSU - Units for ExposureCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC48480 CAPSULE Capsule DosingUnit; capA dosing measurement based on the capsule unit.(NCI)Capsule Dosing UnitC65060 PUFF Puff A means of delivering a defined dose of a therapeuticaerolized solution into either the upper or lowerrespiratory tract. Metered-dose inhalers or spraypumps are devices that provide a puff dose for deliveryinto either the oral or the nasal cavity.(NCI)Puff Dosing UnitC48542 TABLET Tablet DosingUnit; tabA dosing measurement based on the tablet unit.(NCI)Tablet Dosing UnitC48155 g Gram A metric unit of mass equal to one one thousandth of akilogram. (NCI)C28254 mL cm3; Milliliter The unit of volume equal to one thousandth of a liter,one cubic centimeter, 10E-6 cubic meter, orapproximately to 0.061 023 7 cubic inch.(NCI)C28253 mg Milligram The unit of mass equal to one thousandth of a gram or1000 micrograms. One milligram equalsapproximately 0.015432 grain or 35.274 x 10E-6ounce.(NCI)C48152 ug Microgram; mcg A unit of mass equal to one millionth of a gram or onethousandth of a milligram.(NCI)GramMilliliterMilligramMicrogramSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 12 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78429 - EXFLRTU - Unit of Measure for Flow RateCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC64777 mL/min Milliliters perMinuteC67420 mmol/day Millimole per 24HoursC71205 ug/day Microgram perDay; mcg/dayC71211 ug/min Micrograms perMinute; mcg/minC67406 umol/day mcmol/day;Micromoles perDayA metric unit of volumetric flow rate defined as therate at which one milliliter of matter travels during theperiod of time equal to one minute.(NCI)A unit of amount of substance flow rate equivalent tothe rate at which one thousandth of a mole ofsubstance travels or is delivered to a given object orspace over a period of time equal to 24 hours.(NCI)A unit of mass flow rate equivalent to the rate at whichone millionth of a gram of matter travels to a givenobject or space over a period of time equal to twentyfour hours. Microgram per day is also a doseadministration rate unit equal to the rate at which onemillionth of a gram of a product is administered perunit of time equal to twenty four hours.(NCI)A unit of mass flow rate equivalent to the rate at whichone millionth of a gram of matter travels to a givenobject or space over a period of time equal to oneminute. Microgram per minute is also a doseadministration rate unit equal to the rate at which onemillionth of a gram of a product is administered perunit of time equal to one minute.(NCI)A unit of amount of substance flow rate equivalent tothe rate at which one millionth of a mole of substancetravels to a given object or space over a period of timeequal to 24 hours.(NCI)Milliliter per MinuteMillimole per 24 HoursMicrogram per DayMicrogram per MinuteMicromole per 24 HoursSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 13 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78427 - EXINTPU - Unit for the Duration of Treatment InterruptionCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC25529 HOURS Hour; hr A unit measure of time equal to 3,600 seconds or 60minutes. It is approximately 1/24 of a median day.(NCI)HourC48154 min Minute Unit ofTimeA unit measure of time equal to 60 seconds.(NCI)MinuteC42535 sec Second The second is a unit of time with a duration of 919 263177 0 periods of the specified light radiationcorresponding to the transition between the twohyperfine levels of the cesium 133 atom in its groundstate at 0 K. According to the convention, 60 secondsconstitute one minute; 3,600 seconds constitute onehour. Abbreviation Sec. is acceptable in non-scientificusage only.(NCI)SecondSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 14 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78430 - EXPDOSEU - Units for Planned ExposureCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC48480 CAPSULE Capsule DosingUnit; capA dosing measurement based on the capsule unit.(NCI)Capsule Dosing UnitC65060 PUFF Puff A means of delivering a defined dose of a therapeuticaerolized solution into either the upper or lowerrespiratory tract. Metered-dose inhalers or spraypumps are devices that provide a puff dose for deliveryinto either the oral or the nasal cavity.(NCI)Puff Dosing UnitC48542 TABLET Tablet DosingUnit; tabA dosing measurement based on the tablet unit.(NCI)Tablet Dosing UnitC48155 g Gram A metric unit of mass equal to one one thousandth of akilogram. (NCI)C28254 mL cm3; Milliliter The unit of volume equal to one thousandth of a liter,one cubic centimeter, 10E-6 cubic meter, orapproximately to 0.061 023 7 cubic inch.(NCI)C28253 mg Milligram The unit of mass equal to one thousandth of a gram or1000 micrograms. One milligram equalsapproximately 0.015432 grain or 35.274 x 10E-6ounce.(NCI)C48152 ug Microgram; mcg A unit of mass equal to one millionth of a gram or onethousandth of a milligram.(NCI)GramMilligramMilliliterMicrogramSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 15 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78425 - EXROUTE - Exposure Route of AdministrationCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC38250 INTRALESIONAL Administration within or introduced directly into alocalized lesion.(FDA)Intralesional Route of DrugAdministrationC28161 INTRAMUSCULAR Administration within a muscle.(FDA) Intramuscular Route ofAdministrationC38255 INTRAOCULAR Administration within the eye.(FDA) Intraocular Route of DrugAdministrationC38258 INTRAPERITEONEAL Administration within the peritoneal cavity.(FDA) Intraperitoneal Route of DrugAdministrationC38284 NASAL Administration to the nose; administered by way of thenose.(FDA)Nasal Route of Drug AdministrationC38288 ORAL PO Administration to or by way of the mouth.(FDA) Oral Route of Drug administrationC38295 RECTAL Administration to the rectum.(FDA) Rectal Route of Drug AdministrationC38216RESPIRATORY(INHALATION)Administration within the respiratory tract by inhalingorally or nasally for local or systemic effect.(FDA)Inhalation Route of AdministrationC38299 SUBCUTANEOUS SC Administration beneath the skin; hypodermic.Synonymous with the term SUBDERMAL.(FDA)C38304 TOPICAL TOP Administration to a particular spot on the outer surfaceof the body. The E2B term TRANSMAMMARY is asubset of the term TOPICAL.(FDA)C38305 TRANSDERMAL Administration through the dermal layer of the skin tothe systemic circulation by diffusion.(FDA)Subcutaneous Route of DrugAdministrationTopical Route of DrugAdministrationTransdermal Route of DrugAdministrationC38313 VAGINAL Administration into the vagina.(FDA) Vaginal Route of DrugAdministrationSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 16 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78428 - EXVOLTU - Total Volume Administration UnitCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC28254 mL cm3; Milliliter The unit of volume equal to one thousandth of a liter,one cubic centimeter, 10E-6 cubic meter, orapproximately to 0.061 023 7 cubic inch.(NCI)C28253 mg Milligram The unit of mass equal to one thousandth of a gram or1000 micrograms. One milligram equalsapproximately 0.015432 grain or 35.274 x 10E-6ounce.(NCI)C48152 ug Microgram; mcg A unit of mass equal to one millionth of a gram or onethousandth of a milligram.(NCI)MilliliterMilligramMicrogramSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 17 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C83004 - SUNCF - Substance Use Never/Current/Former ClassificationCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC25471 CURRENT Occurring in or belonging to the present time. (NCI) CurrentC25627 FORMER Previous Occurring prior to something else. (NCI) PreviousC70543 NEVER Not ever; at no time in the past. NeverSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 18 of 19 -

CDISC Controlled Terminology CDASH - 2011-07-22C78431 - VSPOS - Vital Signs Position of SubjectCodelist extensible: YesNCI CodeCDISC Submission ValueCDISCSynonym CDISC Definition NCI Preferred TermC62122 SITTING Sitting The state or act of one who sits; the posture of onewho occupies a seat. (NCI)C62166 STANDING Standing The act of assuming or maintaining an erect uprightposition. (NCI)C62167 SUPINE Supine A posterior recumbent body position whereby theperson lies on its back and faces upward. (NCI)SittingStandingSupine PositionSource: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6Source Date: 2011-07-22- page 19 of 19 -