Release Date Request Code NCIt Code CDISC Term Type Change Summary Original New 2009-05-01 18854 C74761 Preferred Term Remove the word 'Ratio' from PT of term 'Albumin/Creatinine Ratio' in SDTM-LBTEST, SDTM-LBTESTCD codelists. Also remove 'Ratio' from SY PT/SY: Albumin/Creatinine Ratio PT/SY Albumin/Creatinine 2009-05-01 18855 C35266 Preferred Term Change C35266 CDISC PT Anisocytosis to C74797 CDISC PT Anisocytes in SDTM-LBTEST, SDTM-LBTESTCD codelists. Code changes also. C35266 PT: Anisocytosis C74797 PT: Anisocytes 2009-05-01 18906 C35267 Preferred Term NCI Code changes from C35267 to C79602 in SDTM-LBTEST, SDTM-LBTESTCD codelists. C35267 PT: Poikilocytes C79602 PT: Poikilocytes 2009-05-01 19014 C49686 Definition Misspelling in Definition for Phase IIa Trial in SDTM-TPHASE codelist. Def: A clinical research protocol generally refered to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. (NCI) Def: A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. (NCI) 2009-05-01 19016 C49688 Definition Misspelling in Definition for Phase IIb Trial in SDTM-TPHASE codelist. Def: A clinical research protocol generally refered to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. (NCI) Def: A clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. (NCI) 2009-05-01 19017 C49399 Definition Misspelling in Definition for CONGENITAL, FAMILIAL AND GENETIC DISORDERS in SDTM-SOC codelist. Def: A class of disorders that encompasses conditions resulting from a congenital, familial hereditary trait or genetic abnormality as is manifested by a characterstic set of symptoms and signs. (NCI) Def: A class of disorders that encompasses conditions resulting from a congenital, familial hereditary trait or genetic abnormality as is manifested by a characteristic set of symptoms and signs. (NCI) 2009-05-01 19018 C49476 Definition Double 'the' in definition for LOINC. Remove first 'the' for better readability. Def: Published by the The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology. Def: Published by The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology. 2009-05-01 19019 C74610 Definition Misspelling in Definition for Dohle Bodies Def: A measurement of the Dohle bodie (blue-gray, basophilic, leukocyte inclusions located in the peripheral cytoplasm of neutrophils) in a biological specimen. Def: A measurement of the Dohle bodies (blue-gray, basophilic, leukocyte inclusions located in the peripheral cytoplasm of neutrophils) in a biological specimen. 2009-05-01 19021 C71032 Definition Misspelling in Definition for NOTCHED T-WAVES Def: Any depression occuring in a positive t wave. (NCI) Def: Any depression occurring in a positive t wave. (NCI) 2009-05-01 19022 C71046 Definition Misspelling in Definition for BIFASICULAR BLOCK Def: An electrocardiographic finding comprising right bundle branch block and left anterior fascicular block, or right bundle branch block and left posterior fascicular block. Defects occuring in two of the three divisions of the conduction system of the heart are considered bifascicular blocks. Technically left bundle branch block may be considered a bifascicular block. (NCI) Def: An electrocardiographic finding comprising right bundle branch block and left anterior fascicular block, or right bundle branch block and left posterior fascicular block. Defects occurring in two of the three divisions of the conduction system of the heart are considered bifascicular blocks. Technically left bundle branch block may be considered a bifascicular block. (NCI) 2009-05-01 19023 C51224 Definition Add word 'is' between 'generally' and 'at' in CDISC definition of ATRIAL FLUTTER to make it more readable. Def: An electrocardiographic finding of an organized rhythmic contraction of the atria which generally at a rate of 200-300 beats per minute. (NCI) Def: An electrocardiographic finding of an organized rhythmic contraction of the atria which is generally at a rate of 200-300 beats per minute. (NCI) 2009-05-01 19025 C44277 Definition Remove second '(NCI)' from end of CDISC definition for C44277 Degree Fahrenheit in SDTM-UNIT, SDTM-VSRESU codelists. Def: The Fahrenheit temperature scale is named after the German physicist Gabriel Fahrenheit (1686-1736), who proposed it in 1724. In this scale, the freezing point of water is 32 degrees Fahrenheit and the boiling point is 212 degrees, placing the boiling and melting points of water 180 degrees apart. In this scale a degree Fahrenheit is 5/9ths of a Kelvin (or of a degree Celsius), and minus 40 degrees Fahrenheit is equal to minus 40 degrees Celsius. (NCI)(NCI) Def: The Fahrenheit temperature scale is named after the German physicist Gabriel Fahrenheit (1686-1736), who proposed it in 1724. In this scale, the freezing point of water is 32 degrees Fahrenheit and the boiling point is 212 degrees, placing the boiling and melting points of water 180 degrees apart. In this scale a degree Fahrenheit is 5/9ths of a Kelvin (or of a degree Celsius), and minus 40 degrees Fahrenheit is equal to minus 40 degrees Celsius. (NCI) 2009-05-01 19026 C51776 Definition Misspelling in Definition for DIVORCED in SDTM-MARISTAT codelist. Def: Marrige contract has been declared dissolved and inactive. (HL7) Def: Marriage contract has been declared dissolved and inactive. (HL7) 2009-05-01 19027 C42546 Definition Stylistic inconsistency in CDISC definition of C42546 Newton in SDTM-UNIT codelist Def: A unit of force which, when applied in a vacuum to a body having a mass of one kilogram, causes an acceleration of one meter/sec(2). It is equal to 10E5 dynes. Def: A unit of force which, when applied in a vacuum to a body having a mass of one kilogram, causes an acceleration of one meter per second squared. It is equal to 10E5 dynes. 2009-05-01 19115 C74688 Preferred Term Change SDTM-LBTEST PT Barbiturate to Barbiturates. Change synonym as well. PT/SY: Barbiturate PT/SY: Barbiturates 2009-05-01 19116 C64470 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the basophils per unit of a biological specimen. Def: A measurement of of the basophils per unit of a biological specimen. 2009-05-01 19120 C64471 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of the basophils to leukocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the basophils to leukocytes in a biological specimen. 2009-05-01 19123 C64487 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of the blasts to leukocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the blasts to leukocytes in a biological specimen. 2009-05-01 19124 C74753 Preferred Term Remove the word 'Ratio' from PT of term 'BUN/Creatinine Ratio' in SDTM-LBTEST, SDTM-LBTESTCD codelists. Also remove 'Ratio' from SY PT/SY: BUN/Creatinine Ratio PT/SY: BUN/Creatinine 2009-05-01 19449 C64549 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the elliptocytes per unit of a biological specimen. Def: A measurement of the elliptically shaped erythrocytes in a biological specimen. 2009-05-01 19450 C64550 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the eosinophils per unit of a biological specimen. Def: A measurement of the eosinophils per unit of a biological specimen. 2009-05-01 19451 C64604 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of the eosinophils to leukocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the eosinophils to leukocytes in a biological specimen. 2009-05-01 19458 C42956, C42945, C42899, C42995, C42926, C42951 Preferred Term Make the Submission Value equal to Preferred Term in SDTM-FRM codelist of published spreadsheet; Terms affected are INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE; INJECTION, SOLUTION; INJECTION, SOLUTION, CONCENTRATE; INJECTION, SUSPENSION; INJECTION, SUSPENSION, EXTENDED RELEASE; INJECTION, SUSPENSION, LIPOSOMAL - - - Make column E = F in FRM codelist. Terms affected are INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE; INJECTION, SOLUTION; INJECTION, SOLUTION, CONCENTRATE; INJECTION, SUSPENSION; INJECTION, SUSPENSION, EXTENDED RELEASE; INJECTION, SUSPENSION, LIPOSOMAL. 2009-05-01 19460 C64818 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the atypical lymphocytes per unit of a biological specimen. Def: A measurement of the atypical lymphocytes per unit of a biological specimen. 2009-05-01 19461 C64819 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of the atypical lymphocytes to leukocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the atypical lymphocytes to leukocytes in a biological specimen. 2009-05-01 19463 C64820 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of the lymphocytes to leukocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the lymphocytes to leukocytes in a biological specimen. 2009-05-01 19464 C74654 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measurement (ratio or percentage) of the reactive lymphocytes (lymphocytes with peripherally clumped chromatin and often deep blue cytoplasm and that appear similar to plasma cells) to all lymphocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the reactive lymphocytes (lymphocytes which have become large due to an antigen reaction) to all lymphocytes in a biological specimen. 2009-05-01 19466 C64821 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the macrocytes per unit of a biological specimen. Def: A measurement of the macrocytes per unit of a biological specimen. 2009-05-01 19540 C17095 Definition The definition for Reunion in the SDTM-COUNTRY codelist is incorrect, gramatically. Def: An Southern Africa, occupying an island in the Indian Ocean, east of Madagascar. Def: A country in Southern Africa, occupying an island in the Indian Ocean, east of Madagascar. 2009-05-01 19575 C64822 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the microcytes per unit of a biological specimen. Def: A measurement of the microcytes per unit of a biological specimen. 2009-05-01 19576 C64823 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the monocytes per unit of a biological specimen. Def: A measurement of the monocytes per unit of a biological specimen. 2009-05-01 19577 C64824 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of the monocytes to leukocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the monocytes to leukocytes in a biological specimen. 2009-05-01 19578 C74646 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measurement (ratio or percentage) of monoblast cells to all leukocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the monoblasts to leukocytes in a biological specimen. 2009-05-01 19579 C64826 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of the myelocytes to leukocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the myelocytes to leukocytes in a biological specimen. 2009-05-01 19580 C63321 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the neutrophils per unit of a biological specimen. Def: A measurement of the neutrophils per unit of a biological specimen. 2009-05-01 19581 C64830 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the banded neutrophils per unit of a biological specimen. Def: A measurement of the banded neutrophils per unit of a biological specimen. 2009-05-01 19582 C64831 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of the banded neutrophils to leukocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the banded neutrophils to leukocytes in a biological specimen. 2009-05-01 19583 C64827 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: The determination of the ratio of neutrophils compared to leukocytes in a blood sample. The measurement may be expressed as a ratio or percentage. Def: A relative measurement (ratio or percentage) of the neutrophils to leukocytes in a biological specimen. 2009-05-01 19584 C74617 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for clarity Def: A measurement of the amount of Pelger Huet anomaly present in a biological specimen. Def: A measurement of the Pelger Huet Anomaly (nuclei of neutrophils and eosinophils appear rod-like, spherical or dumbbell shaped) in a biological specimen. 2009-05-01 19679 C51951 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the platelets per unit of a biological specimen. Def: A measurement of the platelets per unit of a biological specimen. 2009-05-01 19681 C74649 Definition Aberrant symbol in definition in SDTM-TPHASE codelist: remove right parenthesis. Def: A relative measurement (ratio or percentage) of the poikilocytes irregularly shaped erythrocytes) to all erythrocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of the poikilocytes, or irregularly shaped erythrocytes, to all erythrocytes in a biological specimen. 2009-05-01 19682 C51946 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the total erythrocytes per unit of a biological specimen. Def: A measurement of the total erythrocytes per unit of a biological specimen. 2009-05-01 19685 C51947 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the reticulocytes per unit of a biological specimen. Def: A measurement of the reticulocytes per unit of a biological specimen. 2009-05-01 19686 C64828 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of reticulocytes to erythrocytes in a biological specimen. Def: A relative measurement (ratio or percentage) of reticulocytes to erythrocytes in a biological specimen. 2009-05-01 19687 C74786 Preferred Term Correct spelling error - 'e' added to end of Thyroxin in SDTM-LBTEST PT and CDISC SY PT, SY: Thyroxin, Free PT, SY: Thyroxine, Free 2009-05-01 19688 C64801 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of dacryocytes in unit of a biological specimen. Def: A measurement of dacryocytes per unit of a biological specimen. 2009-05-01 19691 C64829 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A relative measure (ratio or percentage) of prolymphocytes to leukocytes in a biological specimen. Def:A relative measurement (ratio or percentage) of prolymphocytes to leukocytes in a biological specimen. 2009-05-01 19692 C51949 Definition Change definition in SDTM-LBTEST, SDTM-LBTESTCD codelists for consistency. Def: A count of the lymphocytes per unit of a biological specimen. Def: A measurement of the lymphocytes per unit of a biological specimen. 2009-05-01 19788 C74634 Preferred Term Bite Cells/Erythrocytes appears twice in LBTEST and LBTESTCD codelist. Remove second one. - - - Remove second Bite Cells/Erythrocytes term in LBTEST and LBTESTCD codelist. 2009-05-01 19802 C74894 Preferred Term Remove the word 'Ratio' from PT of term 'Albumin/Globulin Ratio' in SDTM-LBTEST, SDTM-LBTESTCD codelists. Also remove 'Ratio' from SY PT/SY: Albumin/Globulin Ratio PT/SY: Albumin/Globulin 2009-05-01 20004 C49687 Preferred Term Typo in term Phase IIIaTrial - Space between IIIa and Trial is missing in SDTM-TPHASE codelist. PT: Phase IIIaTrial PT: Phase IIIa Trial 2009-05-01 - - - - - - - - - Removal of Columns J (Pre-release/Production) and K (Notes) from SDTM CT spreadsheet - - - - - -