Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist Change Summary Original New Justification for Denied Request SEND? 2009-10- 18856 II C64802 Preferred Term SDTM-LBTESTCD, SDTM-LBTEST Change CDISC PT to HPOCROM in SDTM-LBTESTCD, SDTM-LBTEST codelist. CDISC PT: HYPO CDISC PT: HPOCROM x 2009-10- 20469 II C74616 Definition SDTM-LBTEST, SDTM-LBTESTCD Modify definition of Pappenheimer Body in LBTEST and LBTESTCD codelists. Def: A measurement of the Pappenheimer Bodies (violet or blue staining, ferritin granules usually found along the periphery of the red blood cells) in a biological specimen. Def: A measurement of the cells containing Pappenheimer Bodies (violet or blue staining ferritin granules usually found along the periphery of the red blood cells) in a biological specimen. x 2009-10- 20530, 21352 II C74767 Preferred Term SDTM-LBTEST, SDTM-LBTESTCD Remove Duplicate term from SDTM-LBTEST, SDTM-LBTESTCD codelists. C74767 FGRANCS - - - x 2009-10- 20530 II C74630 Synonym SDTM-LBTEST, SDTTM-LBTESTCD Alter Synonyms of Leukemic Blasts (BLASTLM) in SDTM-LBTEST, SDTM-LBTESTCD codelists. SY: Leukemic Blasts; Lymphocytes; Lymphoblasts; Immunoblastic SY: Leukemic Blasts, Leukemic Lymphoblasts, Immunoblastic Lymphocytes x 2009-10- 20704 III NEW Preferred Term SDTM-UNIT Add the term 'Pack Year' to SDTM-UNIT codelist. - - - C73993 PT: Pack Year; Def: A quantification of lifetime tobacco exposure defined as (number of cigarettes smoked per day x number of years smoked)/20. One pack-year is smoking 20 cigarettes a day for one year. 2009-10- 20706 III NEW Preferred Term SDTM-FREQ Add the term 'QD' to SDTM-FREQ codelist. - - - C25473 PT: QD; Def: Occurring or done each day. SY: Daily 2009-10- 20825 II C66790 Synonym SDTM-ETHNIC Change the preferred term of the ETHNIC codelist. PT: Patient Ethnic Group PT: Ethnic Group 2009-10- 20830 II C49566 Synonym SDTM-DOMAIN Change the synonym of 'Bone Mineral Density' in SDTM-DOMAIN codelist. SY: Bone Mineral Density (BMD) Data SY: Bone Measurements 2009-10- 20831 II C49700 Preferred Term SDTM-TSPARMCD Remove the term AEDICT in SDTM-TSPARMCD codelist. PT: AEDICT - - - 2009-10- 20832 II C49700 Preferred Term SDTM-TSPARM Remove the term Adverse Event Dictionary in SDTM-TSPARM codelist. PT: Adverse Event Dictionary - - - 2009-10- 20833 II C49701 Preferred Term SDTM-TSPARMCD Remove the term DRUGDICT in SDTM-TSPARMCD codelist. PT: DRUGDICT - - - 2009-10- 20835 II C49701 Preferred Term SDTM-TSPARM Remove the term Drug Dictionary in SDTM-TSPARM codelist. PT: Drug Dictionary - - - 2009-10- 20836 II C49702 Preferred Term SDTM-TSPARMCD Remove the term MHDICT in SDTM-TSPARMCD codelist. PT: MHDICT - - - 2009-10- 20837 II C49702 Preferred Term SDTM-TSPARM Remove the term Medical Dictionary in SDTM-TSPARM codelist. PT: Medical Dictionary - - - 2009-10- 20908 III NEW Preferred Term SDTM-EGSTRESC Add term AV Mobitz I to SDTM-EGSTRESC codelist. - - - NCI Code: C83811; PT: AV Mobitz I; Def: Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles, characterized by a progressively lengthening PR interval prior to the block of an atrial impulse. 2009-10- 20908 III NEW Preferred Term SDTM-EGSTRESC Add term AV Mobitz II to SDTM-EGSTRESC codelist. - - - NCI Code: C83812; PT: AV Mobitz II; Def: Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles, characterized by a relatively constant PR interval prior to the block of an atrial impulse. 2009-10- 21813 II C48152, C48507, C48509, C48510, C67306, C67327, C67394, C67396, C67397, C67406, C69175, C70523, C70526, C70530, C70562, C70571, C70581, C71171, C71173, C71175, C71205, C71210, C71211 Synonym SDTM-UNIT Add synonym where the 'u', to signify micro- prefix, in the preferred term is changed to 'mc'. - - - SY: mcg, mcCi, mcmol, mcm, mcg/L, mcg/m3, mcg/h, mcg/kg, mckat/L, mcmol/day, mcL/mL, Bq/mcg, GBq/mcg, Ci/mcg, mckat, mcCi/kg, mEq/mcg, Ci/mcL, mcCi/L, mcV, mcg/day, mcg/kg/min, mcg/min 2009-10- 19884 I C48542, C48480, C42966, C42993, C42887, C42994, C38288, C38304, C38299 Synonym SDTM-FRM Addition of synonyms that are published in CDASH appendix A. Addition of these synonyms will align CDASH standard with SDTM. - - - SY: C48542 Tablet - tab; C48480 Capsule - cap; C42966 Ointment - oint; C42993 Suppository - supp; C42887 Aerosol - aer; C42994 Suspension - susp; C38288 Oral - PO; C38304 Topical - TOP; C38299 Subcutaneous - SC 2009-10- 21562 I C70527 Synonym SDTM-UNIT Change synonym; transcription error in CDISC Synonym column. SY: MBq/mg, Megabecquerel per Milligram SY: Megabecquerel per Microgram; MBq/mcg, MBq/ug 2009-10- 22116 I NEW Preferred Term SDTM-COUNTRY Addition of new countries to COUNTRY codelist: Isle of Man, Saint Barthelemy, Saint Martin. The island of Saint Martin is divided into two parts; the northern part is an island collectivity of France and the southern part belongs to the Dutch Antilles. The southern portion of the island has not been assigned an ISO country code so we will only add the northern portion to the country codelist for now. - - - NCI Code: C44480; CDISC PT: IMN; SY: Isle of Man; Def: An island in the Irish Sea, between Great Britain and Ireland. NCI Code: C83609; CDISC PT: BLM; SY: Saint Barthelemy; Def: An island in the Caribbean sea, between Saint Martin and Saint Kitts and Nevis. NCI Code: C83610; CDISC PT: MAF, SY: Saint Martin, French; Def: An island in the Caribbean sea, between Anguilla and Saint Barthelemy. x 2009-10- 22116 I C64374, C64377 Preferred Term SDTM-COUNTRY Update three-letter country code of Serbia from SCG to SRB. SCG is transitionally reserved by ISO until end of 2009 when it switches to SRB. Update three-letter country code of Jersey from JRE to JEY. This is a transcription error on the SDTM CT spreadsheet. CDISC PT: SCG (Serbia), JRE (Jersey) CDISC PT: SRB (Serbia), JEY (Jersey) x 2009-10- 22642 I C74606, C74607, C74608, C74609, C51948, C64801, C74699, C64818, C64830, C64470, C64550, C51949, C64821, C64822, C74631, C64823, C74632, C74662, C63321, C51951, C74621, C51948, C51947, C51946 Definition SDTM-LBTEST, LBTESTCD Change Cell Count Definitions to be consistent across all cell count definitions in LBTEST, LBTESTCD codelists. Inconsistent cell count definitions across the LBTEST and LBTESTCD codelists. All cell count measurements will follow this format; Def: A measurement of the X in a biological specimen. 2009-10- 19449 I C64549 Definition SDTM-LBTEST, LBTESTCD Change definition. This change request was accepted in Q1 but never implemented on the published spreadsheet. Def: A measurement of the elliptocytes in a biological specimen. Def: A measurement of the elliptically shaped erythrocytes in a biological specimen. 2009-10- 22970 I C42708 Code SDTM-EVAL Duplicate NCI code in EVAL codelist. NCI code for Parent is incorrect. It should be C42709 in column A of spreadsheet. NCI code: C42708 NCI code: C42709