Release Date	Request Code	Change Type	NCI Code	CDISC Term Type	CDISC Codelist	Change Summary	Original	New
8/3/2012	N/A	III	C102575	Codelist	SDTM-CCINVCTYP	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	II	C100086	Synonym	SDTM-CVEXAM; SDTM-CVEXAMCD	Addition of a synonym to support the CV therapeutic area data standard.	SY: Coronary Artery Dominance	SY: Coronary Artery Dominance; Coronary Anatomy Dominance
8/3/2012	N/A	III	C102576	Codelist	SDTM-DOBSTLOC	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	31900;  31901; 31912; 31918; C31963	III	C66734	Term	SDTM-DOMAIN	Addition of 24 new terms to SDTM-DOMAIN Codelist.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102577	Codelist	SDTM-DRSTAT	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102578	Codelist	SDTM-DSSOUT	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	31674	III	C71150	Term	SDTM-EGSTRESC	Addition of 60 new terms to SDTM-EGSTRESC Codelist.	- - -	See published spreadsheet for new terms.
8/3/2012	32008	I	C49236	C-code	SDTM-EPOCH	Incorrect coding.	C-code: C49236 / NCI Preferred Term:  Therapeutic Procedure	C-code: C101526 / NCI Preferred Term: Treatment Epoch
8/3/2012	N/A	III	C102579	Codelist	SDTM-EVDRETRT	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C101851; C101852	Codelist	SDTM-FATEST; SDTM-FATESTCD	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102580	Codelist	SDTM-LBSTRESC	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C74456	Term	SDTM-LOC	Addition of 11 new terms to SDTM-LOC Codelist.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102581	Codelist	SDTM-MCIDCERT	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C85492	Term	SDTM-METHOD	Addition of 20 new terms to SDTM-METHOD Codelist.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C85491	Term	SDTM-MICROORG	Addition of 4 new terms to SDTM-MICROORG Codelist.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C66727	Term	SDTM-NCOMPLT	Addition of 1 new term to SDTM-NCOMPLT Codelist.	- - -	See published spreadsheet for new terms.
8/3/2012	30863	III	C85493; C85839	Term	SDTM-PKPARM; SDTM-PKPARMCD	Addition of 4 new terms to SDTM-PKPARM and SDTM-PKPARMCD Codelists.	- - -	See published spreadsheet for new terms.
8/3/2012	30863	II	C85761	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration.
8/3/2012	30863	II	C85764	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The percentage of the area under the curve (AUC) extrapolated to infinity from Tlast to infinity based on the observed value for concentration at TLast.	Def: The area under the curve (AUC) from the last observed non-zero concentration value to infinity as a percentage of the area under the curve extrapolated to infinity.
8/3/2012	30863	II	C85765	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration.
8/3/2012	30863	II	C85766	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The percentage of the area under the moment curve (AUMC) extrapolated to infinity from Tlast to infinity based on the observed value for concentration at TLast.	Def: The area under the moment curve (AUMC) from the last observed non-zero concentration value to infinity as a percentage of the area under the moment curve extrapolated to infinity.
8/3/2012	30863	II	C85767	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the observed value of the last excretion rate.
8/3/2012	30863	II	C85768	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The percentage of the area under the urine excretion rate curve (AURC) extrapolated to infinity observed from Tlast to infinity.	Def: The area under the urinary excretion rate curve (AURC) from the last observed non-zero rate value to infinity as a percentage of the area under the urinary excretion rate curve extrapolated to infinity.
8/3/2012	30863	II	C85769	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed mean residence time (MRT) extrapolated to infinity.	Def: The mean residence time (MRT) extrapolated to infinity, calculated using the observed value of the last non-zero concentration.
8/3/2012	30863	II	C85773	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed total body clearance for intravascular administration.	Def: The total body clearance for intravascular administration, calculated using the observed value of the last non-zero concentration.
8/3/2012	30863	II	C85774	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed volume of distribution associated with the terminal slope following intravascular administration.	Def: The volume of distribution associated with the terminal slope following intravascular administration, calculated using the observed value of the last non-zero concentration.
8/3/2012	30863	II	C85785	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration.
8/3/2012	30863	II	C85786	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the dose.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration, divided by the dose.
8/3/2012	30863	II	C85787	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The percentage of the area under the curve (AUC) extrapolated to infinity that was due to back extrapolation to estimate concentration at time zero, based on the predicted value for concentration at time zero.	"Def: The area under the curve (AUC) from the predicted concentration value at time zero to the first measured concentration value as a percentage of the area under the curve extrapolated to infinity. Applies only for intravascular bolus dosing.
"
8/3/2012	30863	II	C85788	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The percentage of the area under the curve (AUC) extrapolated to infinity from Tlast to infinity based on the predicted value for concentration at TLast.	Def: The area under the curve (AUC) from the last predicted non-zero concentration value to infinity as a percentage of the area under the curve extrapolated to infinity.
8/3/2012	30863	II	C85789	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration.
8/3/2012	30863	II	C85790	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The percentage of the area under the moment curve (AUMC) extrapolated to infinity from Tlast to infinity based on the predicted value for concentration at TLast.	Def: The area under the moment curve (AUMC) from the last predicted non-zero concentration value to infinity as a percentage of the area under the moment curve extrapolated to infinity.
8/3/2012	30863	II	C85791	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the predicted value of the last non-zero excretion rate.
8/3/2012	30863	II	C85792	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The percentage of the area under the urine excretion rate curve (AURC) extrapolated to infinity predicted from Tlast to infinity.	Def: The area under the urinary excretion rate curve (AURC) from the last predicted non-zero rate value to infinity as a percentage of the area under the urinary excretion rate curve extrapolated to infinity.
8/3/2012	30863	II	C85793	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted mean residence time (MRT) extrapolated to infinity.	Def: The mean residence time (MRT) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration.
8/3/2012	30863	II	C85797	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted total body clearance for intravascular administration.	Def: The total body clearance for intravascular administration, calculated using the predicted value of the last non-zero concentration.
8/3/2012	30863	II	C85798	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted volume of distribution associated with the terminal slope following intravascular administration.	Def: The volume of distribution associated with the terminal slope following intravascular administration, calculated using the predicted value of the last non-zero concentration.
8/3/2012	30863	II	C85823	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The midpoint of collection interval associated with the maximum observed excretion rate.	Def: The midpoint of collection interval associated with the maximum excretion rate.
8/3/2012	30863	II	C92316	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed area under the curve (AUC) extrapolated to infinity divided by the body mass index.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92317	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed area under the curve (AUC) extrapolated to infinity divided by the surface area.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92318	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed area under the curve (AUC) extrapolated to infinity divided by the weight.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92319	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the body mass index.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92320	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the surface area.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92321	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the weight.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92330	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the body mass index.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92331	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the dose.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration, divided by the dose.
8/3/2012	30863	II	C92332	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the surface area.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92333	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the weight.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92334	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the body mass index.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92335	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the dose.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration, divided by the dose.
8/3/2012	30863	II	C92336	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the surface area.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92337	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the weight.	Def: The area under the moment curve (AUMC) extrapolated to infinity, calculated using the predicted value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92354	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the body mass index.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the observed value of the last excretion rate, divided by the body mass index.
8/3/2012	30863	II	C92355	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the dose.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the observed value of the last excretion rate, divided by the dose.
8/3/2012	30863	II	C92356	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the surface area.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the observed value of the last excretion rate, divided by the surface area.
8/3/2012	30863	II	C92357	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the weight.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the observed value of the last excretion rate, divided by the weight.
8/3/2012	30863	II	C92358	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the body mass index.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the predicted value of the last non-zero excretion rate, divded by the body mass index.
8/3/2012	30863	II	C92359	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the dose.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the predicted value of the last non-zero excretion rate, divded by the dose.
8/3/2012	30863	II	C92360	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the surface area.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the predicted value of the last non-zero excretion rate, divded by the surface area.
8/3/2012	30863	II	C92361	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the weight.	Def: The area under the urinary excretion rate curve (AURC) extrapolated to infinity, calculated using the predicted value of the last non-zero excretion rate, divded by the weight.
8/3/2012	30863	II	C92403	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed total body clearance for intravascular administration divided by the body mass index.	Def: The total body clearance for intravascular administration, calculated using the observed value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92405	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed total body clearance for intravascular administration divided by the surface area.	Def:  The total body clearance for intravascular administration, calculated using the observed value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92406	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed total body clearance for intravascular administration divided by the weight.	Def: The total body clearance for intravascular administration, calculated using the observed value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92407	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed volume of distribution associated with the terminal slope following intravascular administration divided by the body mass index.	Def: The volume of distribution associated with the terminal slope following intravascular administration, calculated using the observed value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92408	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed volume of distribution associated with the terminal slope following intravascular administration divided by the surface area.	Def: The volume of distribution associated with the terminal slope following intravascular administration, calculated using the observed value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92409	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed volume of distribution associated with the terminal slope following intravascular administration divided by the weight.	Def: The volume of distribution associated with the terminal slope following intravascular administration, calculated using the observed value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92421	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted total body clearance for intravascular administration divided by the body mass index.	Def: The total body clearance for intravascular administration, calculated using the predicted value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92423	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted total body clearance for intravascular administration divided by the surface area.	Def: The total body clearance for intravascular administration, calculated using the predicted value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92424	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted total body clearance for intravascular administration divided by the weight.	Def: The total body clearance for intravascular administration, calculated using the predicted value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92425	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted volume of distribution associated with the terminal slope following intravascular administration divided by the body mass index.	Def: The volume of distribution associated with the terminal slope following intravascular administration, calculated using the predicted value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92426	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted volume of distribution associated with the terminal slope following intravascular administration divided by the surface area.	Def: The volume of distribution associated with the terminal slope following intravascular administration, calculated using the predicted value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92427	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted volume of distribution associated with the terminal slope following intravascular administration divided by the weight.	Def: The volume of distribution associated with the terminal slope following intravascular administration, calculated using the predicted value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C96695	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed area under the curve (AUC) extrapolated to infinity divided by the dose.	Def: The area under the curve (AUC) extrapolated to infinity, calculated using the observed value of the last non-zero concentration, divided by the dose.
8/3/2012	30863	II	C85699	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The maximum observed excretion rate.	Def: The maximum excretion rate.
8/3/2012	30863	II	C85772	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed total body clearance for extravascular administration based on the fraction of dose absorbed.	Def: The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration.
8/3/2012	30863	II	C85775	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed.	Def: The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration.
8/3/2012	30863	II	C85796	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	"Def: The predicted total body clearance for extravascular administration based on the fraction of dose absorbed.
"	Def: The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the predicted value of the last non-zero concentration.
8/3/2012	30863	II	C85799	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed.	Def: The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the predicted value of the last non-zero concentration.
8/3/2012	30863	II	C92395	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The maximum observed excretion rate divided by the body mass index.	Def: The maximum excretion rate divided by the body mass index.
8/3/2012	30863	II	C92396	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The maximum observed excretion rate divided by the dose.	Def: The maximum excretion rate divided by the dose.
8/3/2012	30863	II	C92397	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The maximum observed excretion rate divided by the surface area.	Def: The maximum excretion rate divided by the surface area.
8/3/2012	30863	II	C92398	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The maximum observed excretion rate divided by the weight.	Def: The maximum excretion rate divided by the weight.
8/3/2012	30863	II	C92399	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the body mass index.	Def: The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92401	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the surface area.	Def: The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92402	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the weight.	Def: The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92410	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the body mass index.	Def: The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92411	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the surface area.	Def: The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92412	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the weight.	Def: The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92417	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the body mass index.	Def: The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the predicted value of the last non-zero concentration, divided by body mass index.
8/3/2012	30863	II	C92419	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the surface area.	Def: The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the predicted value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92420	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the weight.	Def: The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the predicted value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C92428	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the body mass index.	Def: The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the predicted value of the last non-zero concentration, divided by the body mass index.
8/3/2012	30863	II	C92429	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the surface area.	Def: The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the predicted value of the last non-zero concentration, divided by the surface area.
8/3/2012	30863	II	C92430	Definition	SDTM-PKPARM; SDTM-PKPARMCD	Update to definition for clarity.	Def: The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the weight.	Def: The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the predicted value of the last non-zero concentration, divided by the weight.
8/3/2012	30863	II	C85772	Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Removal of Synonym	SY: Total CL Obs by F; Total CL Obs by Fraction Dose (Bioavailability)	SY: Total CL Obs by F
8/3/2012	30863	II	C85699	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT: Max Obs Excretion Rate; SY: Max Obs Excretion Rate	PT: Max Excretion Rate; SY: Max Excretion Rate
8/3/2012	30863	II	C85775	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Vol Dist of Fract Dose Obs	PT/SY: Vz Obs by F
8/3/2012	30863	II	C85796	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Total CL Pred by Fract Dose	PT/SY: Total CL Pred by F
8/3/2012	30863	II	C85799	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Vol Dist of Fract Dose Pred	PT/SY: Vz Pred by F
8/3/2012	30863	II	C92395	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Max Obs Excretion Rate Norm by BMI	PT/SY: Max Excretion Rate Norm by BMI
8/3/2012	30863	II	C92396	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Max Obs Excretion Rate Norm by Dose	PT/SY: Max Excretion Rate Norm by Dose
8/3/2012	30863	II	C92397	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Max Obs Excretion Rate Norm by SA	PT/SY: Max Excretion Rate Norm by SA
8/3/2012	30863	II	C92398	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Max Obs Excretion Rate Norm by WT	PT/SY: Max Excretion Rate Norm by WT
8/3/2012	30863	II	C92399	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Total CL Obs by Fract Dose Norm by BMI	PT/SY: Total CL Obs by F Norm by BMI
8/3/2012	30863	II	C92401	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Total CL Obs by Fract Dose Norm by SA	PT/SY: Total CL Obs by F Norm by SA
8/3/2012	30863	II	C92402	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Total CL Obs by Fract Dose Norm by WT	PT/SY: Total CL Obs by F Norm by WT
8/3/2012	30863	II	C92410	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Vol Dist of Fract Dose Obs Norm by BMI	PT/SY: Vz Obs by F Norm by BMI
8/3/2012	30863	II	C92411	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Vol Dist of Fract Dose Obs Norm by SA	PT/SY: Vz Obs by F Norm by SA
8/3/2012	30863	II	C92412	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Vol Dist of Fract Dose Obs Norm by WT	PT/SY: Vz Obs by F Norm by WT
8/3/2012	30863	II	C92417	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Total CL Pred by Fract Dose Norm by BMI	PT/SY: Total CL Pred by F Norm by BMI
8/3/2012	30863	II	C92419	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Total CL Pred by Fract Dose Norm by SA	PT/SY: Total CL Pred by F Norm by SA
8/3/2012	30863	II	C92420	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Total CL Pred by Fract Dose Norm by WT	PT/SY: Total CL Pred by F Norm by WT
8/3/2012	30863	II	C92428	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Vol Dist of Fract Dose Pred Norm by BMI	PT/SY: Vz Pred by F Norm by BMI
8/3/2012	30863	II	C92429	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Vol Dist of Fract Dose Pred Norm by SA	PT/SY: Vz Pred by F Norm by SA
8/3/2012	30863	II	C92430	Submission Value; Synonym	SDTM-PKPARM; SDTM-PKPARMCD	Update to Submission Value and Synonym for clarity.	PT/SY: Vol Dist of Fract Dose Pred Norm by WT	PT/SY: Vz Pred by F Norm by WT
8/3/2012	N/A	III	C102582	Codelist	SDTM-PRITBCON	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102583	Codelist	SDTM-REASTINT	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102584	Codelist	SDTM-REASTRT	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102585	Codelist	SDTM-REASTRTF	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102586	Codelist	SDTM-REASTRTNA	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102587	Codelist	SDTM-RISKSOC	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C74559	Term	SDTM-SCCD	Addition of 11 new terms to SDTM-SCCD Codelist.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102588	Codelist	SDTM-SETCON	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102589	Codelist	SDTM-TRTEPSD	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C71620	Term	SDTM-UNIT	Addition of 4 new terms to SDTM-UNIT Codelist.	- - -	See published spreadsheet for new terms.
8/3/2012	N/A	III	C102590	Codelist	SDTM-VCNEVD	Addition of a new codelist to the SDTM terminology set to support the TB therapeutic area data standard.	- - -	See published spreadsheet for new terms.