Change Type NCI Code CDISC Term Type CDISC Codelist Change Summary Original New III C16904 Term SDTM-COUNTRY Deprecate term PT: ANT; SY: NETHERLANDS ANTILLES; Definition: A country in the Caribbean, comprising two island groups in the Caribbean Sea - one includes Curacao and Bonaire north of Venezuela; the other is east of the Virgin Islands. (NCI) - - - III C101226 Term SDTM-COUNTRY Addition of new term to SDTM-COUNTRY codelist. - - - PT: SXM; SY: SINT MAARTEN (DUTCH); Definition: The southern portion of an island in the Caribbean sea, between Anguilla and Saint Barthelemy. (NCI) III C66786 Term SDTM-COUNTRY Addition of 3 new terms to SDTM-COUNTRY codelist - - - See published spreadsheet for new terms. III C99074 Term SDTM-DIR Addition of 1 new term to SDTM-DIRECTIONALITY Codelist - - - See published spreadsheet for new terms. II C34786 Definition SDTM-EGSTRESC Modification of a definition for clarity. Definition: A ventricular arrhythmia characterized by syncopal episodes and a long QT interval, sometimes leading to sudden death due to paroxysmal ventricular arrhythmia. This arrhythmia is associated with a prolongation of repolarization following depolarization of the cardiac ventricles. The prolongation of the Q-T interval combined with torsades de pointes manifests as several different forms; some may be acquired or congenital; some may lead to serious arrhythmia and sudden cardiac death. (NCI) Definition: Long QT Syndrome includes prolongation of the corrected QT interval beyond 440 ms for adult males, 460 ms for adult females and 50 ms in the presence of ventricular depolarization abnormalities (i.e., bundle branch blocks or IVCB more than 120 ms. A normal QT interval in a resting ECG with a failure to shorten with an increase in heart rate qualifies as Long QT Syndrome. II C50799 Definition SDTM-EGSTRESC Modification of a definition for clarity. Definition: An arrhythmia characterized by an irregular pattern of high or low-amplitude waves that cannot be differentiated into QRS complexes or T waves. These electrocardiographic waves occur as a result of fibrillary contractions of the ventricular muscle due to rapid repetitive excitation of myocardial fibers without coordinated contraction of the ventricle. (NCI) Definition: Ventricular Fibrillation is characterized by rapid, usually more than 300 bpm (cycle length: 180 ms or less), grossly irregular ventricular rhythm with marked variability in QRS cycle length, morphology, and amplitude. II C71059 Definition SDTM-EGSTRESC Modification of a definition for clarity. Definition: A condition characterized by a pattern of right bundle branch block (RBBB) and ST-segment elevation within electrocardiogram (ECG) leads V1-V3 . This pattern emerges as a result of a defect in ion channel genes, resulting in abnormal electrophysiological activity in the right ventricle and a propensity to malignant tachyarrhythmias. (NCI) Definition: Polymorphic ventricular tachycardia in the absence of structural heart disease, associated with a baseline ECG pattern during sinus rhythm showing right bundle branch block with ST segment elevation in leads V1 through V3. It can also be characterized by documentation of ECG patterns associated with Brugada Syndrome, some of which may be unmasked when provoked with drugs. The most common genetic mutations identified for Brugada syndrome are in the sodium channel gene SCN5A. II C71060 Definition SDTM-EGSTRESC Modification of a definition for clarity. Definition: Ventricular tachyarrhythmias occurring in association with short QT syndrome. (NCI) Definition: Short QT Syndrome is characterized by a QT interval of less than or equal to 300 ms. I C83811; C83812 C-code SDTM-EGSTRESC C-code change. C-code: C83811; C-code: C83812 C-code: C62017; C-code: C62018 I C71075; C71070 C-code SDTM-EGSTRESC C-code change. C-code: C71075; C-code: C71070 C-code: C35586; C-code: C35398 I C71028 C-code SDTM-EGSTRESC C-code change. C-code: C71028 C-code: C50540 III C71153; C71152 Term SDTM-EGTEST;SDTM-EGTESTCD Addition of 6 new terms to SDTM-EGTEST;SDTM-EGTESTCD Codelist - - - See published spreadsheet for new terms. II C74924 Synonym SDTM-FREQ Addition of a new synonym SY: Per Annum; Per Year SY: Per Annum; Per Year; Every Year II C64498 Synonym SDTM-FREQ Addition of a new synonym SY: Every Month SY: Every Month; Per Month II C74758 Synonym SDTM-LBTEST Addition of a new synonym SY: Ammonium Biurate Crystals SY: Ammonium Biurate Crystals; Ammonium Urate Crystals; Acid Ammonium Urate Crystals II C96636 Synonym SDTM-LBTEST; SDTM-LBTESTCD Addition of a new synonym SY: Leptocytes; Target Cells SY: Leptocytes; Target Cells; Codocytes; Mexican Hat Cells II C98799 Synonym SDTM-LBTEST; SDTM-LBTESTCD Addition of a new synonym SY: von Willebrand Factor SY: von Willebrand Factor; von Willebrand Factor Antigen II C74763 Definition SDTM-LBTEST; SDTM-LBTESTCD Modification of a definition for clarity. Definition: A statement that indicates casts were looked for and not found in a biological specimen. Definition: A statement that indicates casts were looked for in a biological specimen. II C74673 Definition SDTM-LBTEST; SDTM-LBTESTCD Modification of a definition for clarity. Definition: A statement that indicates crystals were looked for and not found in a biological specimen. Definition: A statement that indicates crystals were looked for in a biological specimen. II C74912 Definition SDTM-LBTEST; SDTM-LBTESTCD Modification of a definition for clarity. Definition: A measurement of the ammonium acid urate crystals present in a biological specimen. Definition: A measurement of the acid urate crystals present in a biological specimen. III C65047; C67154 Term SDTM-LBTEST; SDTM-LBTESTCD Addition of 28 new terms to SDTM-LBTEST; SDTM-LBTESTCD Codelist - - - See published spreadsheet for new terms. II C74758 Synonym SDTM-LBTESTCD Addition of a new synonym SY: Ammonium Biurate Crystals; Ammonium Urate SY: Ammonium Biurate Crystals; Ammonium Urate Crystals; Acid Ammonium Urate Crystals II C85772 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value and synonym Submission Value: Total CL Obs by Fract Dose; SY: Total CL Obs by Fract Dose Submission Value: Total CL Obs by F; SY: Total CL Obs by F; Total CL Obs by Fraction Dose (Bioavailability) III C85763 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: AUC %Back Extrapolation Obs / AUCPBEO; SY: AUC %Back Extrapolation Obs; Definition: The percentage of the area under curve extrapolated to infinity that was due to back extrapolation to estimate concentration at time zero, based on the observed value for concentration at time zero. - - - III C85777 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Percent Recovered / RECPCT; SY: Percent Recovered; Definition: The percentage of the dose that is recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval. - - - III C92363 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Amount Recovered Norm by BMI / RECAMTB; SY: Amount Recovered Norm by BMI; Definition: The cumulative amount recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval divided by the body mass index. - - - III C92364 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Amount Recovered Norm by Dose / RECAMTD; SY: Amount Recovered Norm by Dose; Definition: The cumulative amount recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval divided by the dose. - - - III C92365 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Amount Recovered Norm by SA / RECAMTS; SY: Amount Recovered Norm by SA; Definition: The cumulative amount recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval divided by the surface area. - - - III C92366 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Amount Recovered Norm by WT / RECAMTW; SY: Amount Recovered Norm by WT; Definition: The cumulative amount recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval divided by the weight. - - - III C92378 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Conc After the Nth Dose / CNTHDOS; SY: Conc After the Nth Dose; Definition: The concentration at the Nth dose. - - - III C92379 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Conc After the Nth Dose by BMI / CNTHDOSB; SY: Conc After the Nth Dose by BMI; Definition: The concentration at the Nth dose divided by the body mass index. - - - III C92380 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Conc After the Nth Dose by Dose / CNTHDOSD; SY: Conc After the Nth Dose by Dose; Definition: The concentration at the Nth dose divided by the dose. - - - III C92381 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Conc After the Nth Dose by SA / CNTHDOSS; SY: Conc After the Nth Dose by SA; Definition: The concentration at the Nth dose divided by the surface area. - - - III C92382 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Conc After the Nth Dose by WT / CNTHDOSW; SY: Conc After the Nth Dose by WT; Definition: The concentration at the Nth dose divided by the weight. - - - III C92400 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Total CL Obs by Fract Dose Norm by Dose / CLFOD; SY: Total CL Obs by Fract Dose Norm by Dose; Definition: The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the dose. - - - III C92404 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Total CL Obs Norm by Dose / CLOD; SY: Total CL Obs Norm by Dose; Definition: The observed total body clearance for intravascular administration divided by the dose. - - - III C92413 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Percent Recovered Norm by BMI / RECPCTB; SY: Percent Recovered Norm by BMI; Definition: The percentage of the dose that is recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval divided by the body mass index. - - - III C92414 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Percent Recovered Norm by Dose / RECPCTD; SY: Percent Recovered Norm by Dose; Definition: The percentage of the dose that is recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval divided by the dose. - - - III C92415 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Percent Recovered Norm by SA / RECPCTS; SY: Percent Recovered Norm by SA; Definition: The percentage of the dose that is recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval divided by the surface area. - - - III C92416 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Percent Recovered Norm by WT / RECPCTW; SY:Percent Recovered Norm by WT; Definition: The percentage of the dose that is recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval divided by the weight. - - - III C92418 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Total CL Pred by Fract Dose Norm by Dose / CLFPD; SY: Total CL Pred by Fract Dose Norm by Dose; Definition: The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the dose. - - - III C92422 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Total CL Pred Norm by Dose / CLPD; SY: Total CL Pred Norm by Dose; Definition: The predicted total body clearance for intravascular administration divided by the dose. - - - III C85832 Term SDTM-PKPARM; SDTM-PKPARMCD Deprecate term PT: Amount Recovered / RECAMT; SY: Amount Recovered; Definition: The cumulative amount recovered from the specimen type specified in PPSPEC, from dosing to end of the current collection interval. - - - II C85787 Definition SDTM-PKPARM; SDTM-PKPARMCD Modification of a definition for clarity. Definition: 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. Definition: 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. This is only used for IV Bolus dosing. II C70919 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: Time of CMAX Observation PT/SY: Time of CMAX II C85565 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUC Dosing to Last Conc PT/SY: AUC to Last Nonzero Conc II C85569 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUMC Dosing to Last Conc PT/SY: AUMC to Last Nonzero Conc II C85571 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AURC Dosing to Last Conc PT/SY: AURC to Last Nonzero Rate II C85580 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: Midpoint of Entire Collection Interval PT/SY: Midpoint of Collection Interval II C85655 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: Last Conc Last Nonzero Conc PT/SY: Last Nonzero Conc II C85700 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: MRT Last MRT to Last Nonzero Conc PT/SY: MRT to Last Nonzero Conc II C85817 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: Sum of Urine Vol Used for PK Parameters PT/SY: Sum of Urine Vol II C92305 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUC Dosing to Last Conc Norm by WT PT/SY: AUC to Last Nonzero Conc Norm by WT II C92309 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUC Dosing to Last Conc Norm by BMI PT/SY: AUC to Last Nonzero Conc Norm by BMI II C92310 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUC Dosing to Last Conc Norm by Dose PT/SY: AUC to Last Nonzero Conc Norm by Dose II C92311 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUC Dosing to Last Conc Norm by SA PT/SY: AUC to Last Nonzero Conc Norm by SA II C92326 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUMC Dosing to Last Conc Norm by BMI PT/SY: AUMC to Last Nonzero Conc Norm by BMI II C92327 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUMC Dosing to Last Conc Norm by Dose PT/SY: AUMC to Last Nonzero Conc Norm by Dose II C92328 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUMC Dosing to Last Conc Norm by SA PT/SY: AUMC to Last Nonzero Conc Norm by SA II C92329 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AUMC Dosing to Last Conc Norm by WT PT/SY: AUMC to Last Nonzero Conc Norm by WT II C92346 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AURC Dosing to Last Conc Norm by BMI PT/SY: AURC to Last Nonzero Rate Norm by BMI II C92347 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AURC Dosing to Last Conc Norm by Dose PT/SY: AURC to Last Nonzero Rate Norm by Dose II C92348 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AURC Dosing to Last Conc Norm by SA PT/SY: AURC to Last Nonzero Rate Norm by SA II C92349 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: AURC Dosing to Last Conc Norm by WT PT/SY: AURC to Last Nonzero Rate Norm by WT II C92387 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym PT/SY: Last Conc Norm by BMI PT/SY: Last Nonzero Conc Norm by BMI II C92388 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym Last Conc Norm by Dose PT/SY: Last Nonzero Conc Norm by Dose II C92389 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym Last Conc Norm by SA PT/SY: Last Nonzero Conc Norm by SA II C92390 Submission value; Synonym SDTM-PKPARM; SDTM-PKPARMCD Update submission value in PKPARM codelist and synonym Last Conc Norm by WT PT/SY: Last Nonzero Conc Norm by WT III C85493; C85839 Term SDTM-PKPARM; SDTM-PKPARMCD Addition of 49 new term to SDTM-PKPARM; SDTM-PKPARMCD Codelist - - - See published spreadsheet for new terms. III C78737 Codelist SDTM-RELTYPE Add SDTM codelist to SEND terminology. - - - New Codelist: SDTM-RELTYPE. See publication spreadsheet II C38284 Synonym SDTM-ROUTE Addition of a new synonym - - - SY: Intranasal Route of Administration II C38288 Synonym SDTM-ROUTE Addition of a new synonym SY: PO SY: PO; Intraoral Route of Administration II C38208 Synonym SDTM-ROUTE Addition of a new synonym - - - SY: Intratracheal Route of Administration III C66729 Term SDTM-ROUTE Addition of 3 new terms to SDTM-ROUTE codelist - - - See published spreadsheet for new terms. III C71620 Term SDTM-UNIT Addition of 5 new terms to SDTM-UNIT codelist - - - See published spreadsheet for new terms. I C3367 C-code SEND-CLCAT Change c-code for CLINICAL SIGNS from C3367 to C100104 C-code: C3367 C-code: C100104 II C82637 Definition SEND-DESIGN Modification of a definition to align with CT.gov and clinical. Definition: A type of study or trial in which each study subject receives the same series of treatments or protocol agents, but in a random order that differs across arms of the study. Each subject serves as their own control in this type of study. Definition: Participants receive one of two or more alternative intervention(s) during the initial epoch of the study and receive other intervention(s) during the subsequent epoch(s) of the study. II C82638 Definition SEND-DESIGN Modification of a definition to align with CT.gov and clinical. Definition: A type of study or trial in which two or more treatments are given alone and in combination, such that all possible combinations are represented across the treatment arms, and are compared in parallel against the study control group. Definition: Two or more interventions, each alone and in combination, are evaluated in parallel against a control group. II C82639 Definition SEND-DESIGN Modification of a definition to align with CT.gov and clinical. Definition: A type of study or trial in which subjects are assigned to a treatment arm at the beginning of the trial and continue in that arm throughout the length of the trial. Study subjects are only supposed to be exposed to the treatment that is assigned to the particular study arm they are enrolled in. Definition: Participants are assigned to one of two or more arms in parallel for the duration of the study. III C88025 Term SEND-NEOPLASM Addition of 2 new terms to SEND-NEOPLASM Codelist - - - See published spreadsheet for new terms. II C3764 Synonym SEND-NEOPLASM Addition of a new synonym SY: POLYPOID ADENOMA SY: POLYPOID ADENOMA; POLYP, GLANDULAR, BENIGN II C6803 Synonym SEND-NEOPLASM Addition of a new synonym SY: SEX CORD STROMAL TUMOR, BENIGN; BENIGN SEX CORD-STROMAL NEOPLASM OF THE OVARY; BENIGN SEX CORD-STROMAL TUMOR OF THE OVARY; BENIGN OVARIAN SEX CORD-STROMAL NEOPLASM; BENIGN SEX CORD-STROMAL TUMOR OF OVARY; BENIGN SEX CORD-STROMAL NEOPLASM OF OVARY SY: SEX CORD STROMAL TUMOR, BENIGN; BENIGN SEX CORD-STROMAL NEOPLASM OF THE OVARY; BENIGN SEX CORD-STROMAL TUMOR OF THE OVARY; BENIGN OVARIAN SEX CORD-STROMAL NEOPLASM; BENIGN SEX CORD-STROMAL TUMOR OF OVARY; BENIGN SEX CORD-STROMAL NEOPLASM OF OVARY; SEX-CORD/STROMAL TUMOR, BENIGN II C12767 Synonym SEND-SPEC Addition of a new synonym SY: Pelvic Cavity; Pelvis SY: Pelvic Cavity; Pelvis; Pelvic Region I C49664 Submission value SEND-SSTYP Spelling Error PT: BIOAVAILBILITY PT: BIOAVAILABILITY III C66734 Term SDTM-DOMAIN Addition of 24 new terms to SDTM-DOMAIN Codelist. - - - See published spreadsheet for new terms. III C71150 Term SDTM-EGSTRESC Addition of 60 new terms to SDTM-EGSTRESC Codelist. - - - See published spreadsheet for new terms. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. " 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. II C85699 Definition SDTM-PKPARM; SDTM-PKPARMCD Update to definition for clarity. Def: The maximum observed excretion rate. Def: The maximum excretion rate. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 III C71620 Term SDTM-UNIT Addition of 4 new terms to SDTM-UNIT Codelist. - - - See published spreadsheet for new terms.