Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist Change Summary Original New 6/29/2012 P10 III CNEW Codelist SDTM-ACSPCAT Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CACRDSC Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CADPRSN Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CADRISK Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CADSYMP Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CARTDOM Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CCRCLS Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CCRCLSCD Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 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) - - - 6/29/2012 P10 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) 6/29/2012 P10 III C66786 Term SDTM-COUNTRY Addition of 3 new terms to SDTM-COUNTRY codelist - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CRYDFMAN Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CSLVLNIM Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CVEXAM Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CVEXAMCD Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CVLSTSEV Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CVLVRSEV Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CVPRCIND Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-CVSLDEXT Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-DIABTHPY Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III C99074 Term SDTM-DIR Addition of 1 new term to SDTM-DIRECTIONALITY Codelist - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-DISCHDX Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 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. 6/29/2012 P10 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. 6/29/2012 P10 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. 6/29/2012 P10 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. 6/29/2012 32188 I C83811; C83812 C-code SDTM-EGSTRESC C-code change. C-code: C83811; C-code: C83812 C-code: C62017; C-code: C62018 6/29/2012 32189 I C71075; C71070 C-code SDTM-EGSTRESC C-code change. C-code: C71075; C-code: C71070 C-code: C35586; C-code: C35398 6/29/2012 32190 I C71028 C-code SDTM-EGSTRESC C-code change. C-code: C71028 C-code: C50540 6/29/2012 P10 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. 6/29/2012 P10 III C99079 Term SDTM-EPOCH Addition of 2 new terms to SDTM-EPOCH Codelist - - - See published spreadsheet for new terms. 6/29/2012 P10 II C74924 Synonym SDTM-FREQ Addition of a new synonym SY: Per Annum; Per Year SY: Per Annum; Per Year; Every Year 6/29/2012 P10 II C64498 Synonym SDTM-FREQ Addition of a new synonym SY: Every Month SY: Every Month; Per Month 6/29/2012 P10 III CNEW Codelist SDTM-GRSTNLOC Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 II C17649 Synonym SDTM-INTTYPE Addition of a new synonym - - - SY: Other 6/29/2012 P10 III CNEW Codelist SDTM-KILLIPC Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 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 6/29/2012 P10 II C96636 Synonym SDTM-LBTEST; SDTM-LBTESTCD Addition of a new synonym SY: Leptocytes; Target Cells SY: Leptocytes; Target Cells; Codocytes; Mexican Hat Cells 6/29/2012 P10 II C98799 Synonym SDTM-LBTEST; SDTM-LBTESTCD Addition of a new synonym SY: von Willebrand Factor SY: von Willebrand Factor; von Willebrand Factor Antigen 6/29/2012 P10 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. 6/29/2012 P10 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. 6/29/2012 P10 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. 6/29/2012 P10 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. 6/29/2012 P10 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 6/29/2012 P10 III CNEW Codelist SDTM-LEADABN Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-LEADSTAT Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 II C32888 Submission value; Synonym SDTM-LOC Change to submission value and addition of new synonym PT: JAW JOINT; SY: Jaw Joint PT: TEMPOROMANDIBULAR JOINT; SY: Jaw Joint; TMJ 6/29/2012 P10 II C12767 Synonym SDTM-LOC Addition of a new synonym SY: Pelvic Cavity; Pelvis SY: Pelvic Cavity; Pelvis; Pelvic Region 6/29/2012 P10 II C12872 Synonym SDTM-LOC Addition of a new synonym SY: Left Coronary Artery SY: Left Coronary Artery; Left Main Coronary Artery; Left Main Coronary Artery Segment; LM 6/29/2012 P10 III C74456 Term SDTM-LOC Addition of 113 new terms to SDTM-LOC Codelist - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-LSNCMPX Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-LVEFMRE Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-MCRCSPTM Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 32185 I C86100; C86179; C86384 Submission value SDTM-MICROORG Spelling Errors PT: ACTINOBACILLUS LIGNIERSSI; PT: BACTEROIDES THETAIOTAMICRON; PT: EUBACTERIUM ADACTOLYTICUM "PT: ACTINOBACILLUS LIGNIERESII; PT: BACTEROIDES THETAIOTAOMICRON; PT: EUBACTERIUM ALACTOLYTICUM " 6/29/2012 P10 III C66727 Term SDTM-NCOMPLT Addition of 1 new term to SDTM-NCOMPLT Codelist - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-NORMABNM Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-NSYSPCID Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-NYHAC Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 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) 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. - - - 6/29/2012 P10 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. 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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 6/29/2012 P10 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. 6/29/2012 P10 III CNEW Codelist SDTM-PROCEDUR Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-PRURGNCY Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 II C38284 Synonym SDTM-ROUTE Addition of a new synonym - - - SY: Intranasal Route of Administration 6/29/2012 P10 II C38288 Synonym SDTM-ROUTE Addition of a new synonym SY: PO SY: PO; Intraoral Route of Administration 6/29/2012 P10 II C38208 Synonym SDTM-ROUTE Addition of a new synonym - - - SY: Intratracheal Route of Administration 6/29/2012 P10 III C66729 Term SDTM-ROUTE Addition of 3 new terms to SDTM-ROUTE codelist - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-RSKASMT Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III CNEW Codelist SDTM-SDTHSDTP Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III C66783 Codelist SDTM-SOC Deprecate codelist per amendment_1_to_study_data_tabulation_model_v1_2_and_sdtmig_v3_1_2_final_2011_12_14", --SOC is the MedDRA primary System Organ Class. This terminology will be available through MedDRA. Codelist: SOC - - - 6/29/2012 P10 III CNEW Codelist SDTM-TIMIFLOW Addition of a new codelist to the SDTM Controlled Terminology - - - See published spreadsheet for new terms. 6/29/2012 P10 III C71620 Term SDTM-UNIT Addition of 5 new terms to SDTM-UNIT codelist - - - See published spreadsheet for new terms. 6/29/2012 P10 III C88025 Term SEND-NEOPLASM Addition of 2 new terms to SEND-NEOPLASM Codelist - - - See published spreadsheet for new terms. 6/29/2012 P10 II C3764 Synonym SEND-NEOPLASM Addition of a new synonym SY: POLYPOID ADENOMA SY: POLYPOID ADENOMA; POLYP, GLANDULAR, BENIGN 6/29/2012 P10 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