Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist Change Summary Original New 3/5/2010 19884 II C25158 C42998 Synonym SDTM-FRM Add SY of 'cap' and 'tab' to Capsule and Tablet Dosage Form on SDTM-FRM codelists. - - - SY: cap; SY: tab 3/5/2010 22292 III NEW Preferred Term SDTM-UNIT Add new units to UNITS codelist: U/L; U/mL; U/kg; U/mg; U/g - - - C67456 Unit per Liter - An arbitrary unit of substance concentration equal to the concentration at which one liter of mixture contains one unit of a substance. C77607 Unit per Milliliter - An arbitrary unit of substance content expressed in unit(s) per milliliter. C67465 Unit per Kilogram - An arbitrary unit of substance content expressed in units of biological activity per unit of mass equal to one kilogram. Unit per kilogram is also used as a dose calculation unit expressed in arbitrary units per one kilogram of body mass. C73780 Unit per Milligram - An arbitrary unit of substance content expressed in unit(s) per milligram. C77606 Unit per Gram - An arbitrary unit of substance content expressed in unit(s) per gram. 3/5/2010 22324 III NEW Preferred Term SDTM-VSTEST, SDTM-VSTESTCD Addition of Saggital Abdominal Diameter (SAD) to VSTEST and VSTESTCD codelists. - - - C87054 CDISC PT: SAD, Sagittal Abdominal Diameter; Def: A standard measure of visceral obesity, or abdominal fat, which is measured from the patient's back to upper abdomen between the bottom of the rib cage and the top of the pelvic area. This measurement may be taken with the patient standing or in the supine position. 3/5/2010 22485 II C66728 Definition SDTM-STENRF Change the definition of the STENRF codelist. Def: The name of a code list that contains terms that reference timepoints within and without a defined time period. Def: The relative relationship of a timepoint to a reference timepoint. 3/5/2010 - I C74797, C79602, C38037 NCI PT SDTM-LBTEST, LBTESTCD Update NCI PT in column I ('eye'). Anisocytosis, Poikilocytosis, Total Bilirubin Anisocyte Measurement, Poikilocyte Measurement, Total Bilirubin Measurement 3/5/2010 - I C71076 NCI PT SDTM-EGSTRESC Update NCI PT in column I ('eye'). NCI PT: Left Ventricular Hypertrophy NCI PT: EKG Finding Left Ventricular Hypertrophy 3/5/2010 - I C71077 NCI PT SDTM-EGSTRESC Update NCI PT in column I ('eye'). NCI PT: Right Ventricular Hypertrophy NCI PT: EKG Finding Right Ventricular Hypertrophy 3/5/2010 20829, 26342 II C66709 CDISC Long Name and SY of Codelist SDTM-ETHNIC Change column D and column G of SDTM terminology spreadsheet Ethnic Group 3/5/2010 22280; 22464 III NEW New Codelist SDTM-TOXGR Create new codelist corresponding to CTCAE v4.0 for TOXGR. Include Grade 0 Adverse Event as a codelist value. - - - See published spreadsheet. New codelist included after the existing SDTM-TOXGR v3.0 codelist. 3/5/2010 22775; P4 II C38037 Synonym SDTM-LBTEST, LBTESTCD Add 'Total Bilirubin' to LBTEST and LBTESTCD codelists as a synonym to 'Bilirubin'. - - - SY: Total Bilirubin 3/5/2010 P4 III C85441; C85442 Preferred Term SDTM-DOMAIN Addition of two new domains to SDTM-DOMAIN codelist: CE, FA - - - PT: CE; PT: FA 3/5/2010 P4 III C25456; C53279 Preferred Term SDTM-STENRF Addition of two new terms to SDTM-STENRF codelist; Coincident, Ongoing - - - PT: COINCIDENT; PT: ONGOING 3/5/2010 P4 III C85582; C85800; C85826; C85827; C70793 Preferred Term SDTM-TSPARM, SDTM-TSPARMCD Addition of five new terms to SDTM-TSPARM, SDTM-TSPARMCD codelist. - - - See published spreadsheet. Terms included at end of existing codelist. 3/5/2010 P4 III C70793 Synonym SDTM-EVAL Addition of new synonym to SDTM-EVAL codelist SY: Study Sponsor; Sponsor SY: Clinical Study Sponsor; Study Sponsor; Sponsor 3/5/2010 P4 II C74794 Synonym SDTM-LBTEST, LBTESTCD Addition of new synonym to SDTM-LBTEST, TESTCD codelist SY: Thyroxine SY: Thyroxine; Total T4 3/5/2010 P4 II C74747 Synonym SDTM-LBTEST, LBTESTCD Addition of new synonym to SDTM-LBTEST, TESTCD codelist SY: Triiodothyronine SY: Triiodothyronine; Total T3 3/5/2010 P4 II C74793 Synonym SDTM-LBTEST, LBTESTCD Addition of new synonym to SDTM-LBTEST, TESTCD codelist SY: Testosterone SY: Testosterone; Total Testosterone 3/5/2010 P4 I C43234; C42935; C74667 Definition SDTM-ETHNIC; SDTM-DOSFRM; SDTM-LBTEST/LBTESTCD Add a period to end of definition. Added period to end of definitions. 3/5/2010 P4 III NEW Preferred Term SDTM-LBTEST, LBTESTCD Addition of new Terms (162) to SDTM-LBTEST and LBTESTCD codelist. - - - See published spreadsheet. Terms included at end of existing codelist. 3/5/2010 P4 III NEW New Codelist SDTM-MSRESCAT Addition of new codelist - - - See published spreadsheet. Terms included at end of existing terminology codelists. 3/5/2010 P4 III NEW New Codelist SDTM-MICROORG Addition of new codelist - - - See published spreadsheet. Terms included at end of existing terminology codelists. 3/5/2010 P4 III NEW New Codelist SDTM-METHOD Addition of new codelist - - - See published spreadsheet. Terms included at end of existing terminology codelists. 3/5/2010 P4 III NEW New Codelist SDTM-PKUNIT Addition of new codelist - - - See published spreadsheet. Terms included at end of existing terminology codelists.