Release Date Request Code NCIt Code CDISC Term Type Change Summary Original New 2009-07-06 18857 C74614 Definition Modify definition for May-Hegglin Anomaly in SDTM-LBTEST and SDTM-LBTESTCD codelists. Def: A measurement of the amount of May-Hegglin anomaly present in a blood sample. Def: A measurement of the May-Hegglin anomaly in a blood sample. This anomaly is characterized by large, misshapen platelets and the presence of Dohle bodies in leukocytes. 2009-07-06 18881 C64433 Synonym Add SY for ALT: SGPT in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: SGPT 2009-07-06 19122 C64467 Synonym Add SY for AST: SGOT in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: SGOT 2009-07-06 19125 C61032 Synonym Add SY for Cholesterol: Total Cholesterol in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Total Cholesterol 2009-07-06 19449 C64549 Synonym Add SY for Elliptocytes: Ovalocytes in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Ovalocytes 2009-07-06 19452 C74782 Synonym Add SY for Estradiol: Oestradiol in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Oestradiol 2009-07-06 19454 C74676 Preferred Term Change SDTM-LBTESTCD PT from FOLICAC to VITB9. PT: FOLICAC PT: VITB9 2009-07-06 19455 C64847 Definition Modify definition of Gamma Glutamyl Transferase in LBTEST and LBTESTCD codelists. Change Transpeptidase to Transferase. Def: A measurement of the gamma glutamyl transpeptidase in a biological specimen. Def: A measurement of the gamma glutamyl transferase in a biological specimen. 2009-07-06 19456 C64851 Synonym Add SY for HCG: Pregnancy Test in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Pregnancy Test 2009-07-06 19457 C74739 Synonym Add SY to term Glutamate: Glutamic Acid in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Glutamic Acid 2009-07-06 19542 C16334 Definition Add definition for Bermuda in SDTM-COUNTRY codelist. - - - Def: A group of islands in the North Atlantic Ocean, east of South Carolina. 2009-07-06 19574 C64798 Preferred Term, Synonym Change SDTM-LBTEST PT from Ery. Mean Corpuscular HB Concentration to Ery. Mean Corpuscular HGB Concentration. PT: Ery. Mean Corpuscular HB Concentration PT/SY: Ery. Mean Corpuscular HGB Concentration 2009-07-06 19585 C64857 Synonym Add SY to term Phosphate: Phosphorus in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Phosphorus 2009-07-06 19653 C48227 Definition Modify definition of 'LOST TO FOLLOW-UP' in SDTM-NCOMPLT codelist. Def: The loss or lack of continuation of follow-up after a study has officially closed. See Follow-up. (NCI) Def: The loss or lack of continuation of a subject to follow-up. 2009-07-06 19678 C41340 Definition Modify definition of 'SEVERE' in SDTM-AESEV, SDTM-TOXGR codelist. Def: A type of adverse event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living, or significantly affects clinical status. The event possesses a significant risk of harm to the research participant and hospitalization may be required. Def: A type of adverse event that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. 2009-07-06 19682 C51946 Synonym Add SY for Erythrocytes: Red Blood Cells in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Red Blood Cells 2009-07-06 19683 C74705 Synonym Add SY for term RBCNUC: Nucleated Red Blood Cells in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Nucleated Red Blood Cells 2009-07-06 19684 C74647 Synonym Add SY for Nucleated Erythrocytes/Erythrocytes: Nucleated Red Blood Cells/Erythrocytes in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Nucleated Red Blood Cells/Erythrocytes 2009-07-06 19688 C64801 Synonym Add SY for Dacryocytes: Tear Shaped Erythrocytes in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Tear Shaped Erythrocytes 2009-07-06 19689 C64814 Synonym Add SY for Urate: Uric Acid in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: Uric Acid 2009-07-06 19690 C51948 Synonym Add SY for WBC: White Blood Cells in SDTM-LBTEST, SDTM-LBTESTCD codelists. - - - SY: White Blood Cells 2009-07-06 19704 C66727 Definition Modify definition of 'NCOMPLT' in SDTM-NCOMPLT codelist. Def: The reason that a subject was discontinued from a clinical trial. Def: The status of the subject's completion of the study or a segment of the study, or the reason the subject discontinued the study or segment of the study. 2009-07-06 19750 C74792, C75386 Preferred Term, Synonym Change PT and code of 'Somatotropin' to 'Somatotrophin' from codelist SDTM-LBTEST and SDTM-LBTESTCD. Additionally, Somatotrophin and C75386 Growth Hormone are synonyms. Remove C75386 from LBTEST and LBTESTCD codelists and add Growth Hormone as a synonym of C80360. Code: C74792; PT: Somatotropin; PT: Growth Hormone Code: C80360; PT: Somatotrophin; SY: Growth Hormone; Def: A measurement of the somatotrophin (growth) hormone in a biological specimen. Removed C75386 Growth Hormone/GRWH from LBTEST and LBTESTCD codelist. 2009-07-06 19904 C74676 Preferred Term Change SDTM-LBTEST PT from Folic Acid to Vitamin B9. PT: Folic Acid PT: Vitamin B9, SY: Folic Acid 2009-07-06 20796 C74768 Definition Misspelling in definition for 'Granular Casts' in SDTM-LBTEST, SDTM-LBTESTCD codelist. Def: A measurement of the granular (course and fine) casts present in a urine specimen. Def: A measurement of the granular (coarse and fine) casts present in a urine specimen. 2009-07-06 20964 C49641 Definition Misspelling in Definition for 'In Utero' in SDTM-AGESPAN codelist. Def: The period of time during which the embryo or foetus is present in the uterus of the female. Also describes the location of the embryo or foetus as being in the uterus in contrast to outside the uterus (ex utero). (NCI) Def: The period of time during which the embryo or fetus is present in the uterus of the female. Also describes the location of the embryo or fetus as being in the uterus in contrast to outside the uterus (ex utero). (NCI) 2009-07-06 20967 C34786 Definition Misspelling in Definition for 'VENTRICULAR ARRHYTHMIA ASSOCIATED WITH LONG QT SYNDROME' in SDTM-EGSTRESC codelist. 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 repolarisation 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) 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) 2009-07-06 20969 C42554 Definition Misspelling in Definition for Ohm in SDTM-VSRESU codelist. Def: A unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one Ampere. Ohm is also used to measure impedance and reactance for complex resistance. A measurement in ohms is the reciprocal of a measurement in siemens.(NCI) Def: A unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one Ampere. Ohm is also used to measure impedance and reactance for complex resistance. A measurement in ohms is the reciprocal of a measurement in Siemens.(NCI) 2009-07-06 20970 C42555 Definition Misspelling in Definition for Siemens in SDTM-UNIT codelist. A unit of electrical conductance, admittance, and susceptance. A conductor has a conductance of one siemens if an electrical potential difference of one volt produces a one Ampere current in it. The conductance in siemens is the reciprocal of its resistance in ohms.(NCI) A unit of electrical conductance, admittance, and susceptance. A conductor has a conductance of one Siemens if an electrical potential difference of one volt produces a one Ampere current in it. The conductance in Siemens is the reciprocal of its resistance in ohms.(NCI) 2009-07-06 20971 C42554 Definition Misspelling in Definition for Ohm in SDTM-UNIT codelist. Def: A unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one ampere. Ohm is also used to measure impedance and reactance for complex resistance. A measurement in ohms is the reciprocal of a measurement in siemens.(NCI) Def: A unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one Ampere. Ohm is also used to measure impedance and reactance for complex resistance. A measurement in ohms is the reciprocal of a measurement in Siemens.(NCI) 2009-07-06 20972 C42558 Definition Misspelling in Definition for Henry in SDTM-UNIT codelist. Def: A unit of electric inductance. A coil with an inductance of one Henry requires a flux of one weber for each Ampere of induced current. If it is the current which changes, then the induced field will generate a potential difference within the coil: if the inductance is one henry a current change of one Ampere per second generates a potential difference of one volt. The Henry is a large unit; inductances in practical circuits are measured in millihenrys or microhenrys.(NCI) Def: A unit of electric inductance. A coil with an inductance of one Henry requires a flux of one Weber for each Ampere of induced current. If it is the current which changes, then the induced field will generate a potential difference within the coil: if the inductance is one Henry a current change of one Ampere per second generates a potential difference of one volt. The Henry is a large unit; inductances in practical circuits are measured in milliHenrys or microHenrys.(NCI) 2009-07-06 20973 C44277 Definition Misspelling in Definition for F in SDTM-VSRESU codelist. 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) 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) 2009-07-06 20975 C54711 Definition Misspelling in Definition for 'atm' in SDTM-UNIT codelist. Def: A unit of pressure, equal to a barometer reading of 760 mm Hg. 1 atmosphere is 101325 pascals and 1.01325 bar. This unit of pressure is roughly equal to the average atmospheric pressure at sea level on the earth.(NCI) Def: A unit of pressure, equal to a barometer reading of 760 mm Hg. 1 atmosphere is 101325 Pascals and 1.01325 bar. This unit of pressure is roughly equal to the average atmospheric pressure at sea level on the earth.(NCI) 2009-07-06 20977 C68915 Definition Misspelling in Definition for 'Gauss' in SDTM-UNIT codelist. Def: The unit of magnetic flux density. A field of one Gauss exerts a force on a conductor, placed in the field of 0.1 dyne per Ampere of current per centimeter of conductor. One Gauss represents a magnetic flux of one Maxwell per square centimeter of cross-section perpendicular to the field. One Gauss equals 10-4 tesla.(NCI) Def: The unit of magnetic flux density. A field of one Gauss exerts a force on a conductor, placed in the field of 0.1 dyne per Ampere of current per centimeter of conductor. One Gauss represents a magnetic flux of one Maxwell per square centimeter of cross-section perpendicular to the field. One Gauss equals 10-4 Tesla.(NCI) 2009-07-06 20978 C70511 Definition Misspelling in Definition for 'kBQ' in SDTM-UNIT codelist. Def: A unit of radioactivity equal to one thousand nuclear disintegrations or other nuclear transformations per second, or to 10E3 becquerels.(NCI) Def: A unit of radioactivity equal to one thousand nuclear disintegrations or other nuclear transformations per second, or to 10E3 Becquerels.(NCI) 2009-07-06 20978 C70512 Definition Misspelling in Definition for 'MBQ' in SDTM-UNIT codelist. Def: A unit of radioactivity equal to one million nuclear disintegrations or other nuclear transformations per second, or to 10E6 becquerels.(NCI) Def: A unit of radioactivity equal to one million nuclear disintegrations or other nuclear transformations per second, or to 10E6 Becquerels.(NCI) 2009-07-06 20978 C70513 Definition Misspelling in Definition for 'GBQ' in SDTM-UNIT codelist. Def: A unit of radioactivity equal to one billion nuclear disintegrations or other nuclear transformations per second, or to 10E9 becquerels.(NCI) Def: A unit of radioactivity equal to one billion nuclear disintegrations or other nuclear transformations per second, or to 10E9 Becquerels.(NCI) 2009-07-06 20978 C71168 Definition Misspelling in Definition for 'kBq/uL' in SDTM-UNIT codelist. Def: A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one thousand becquerels per unit volume equal to one millionth of a liter.(NCI) Def: A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one thousand Becquerels per unit volume equal to one millionth of a liter.(NCI) 2009-07-06 20980 C71061 Definition Misspelling in Definition for 'FASCICULAR TACHYCARDIA' in SDTM-EGSTRESC codelist. Def: A distinct subgroup of idiopathic ventricular tachycardia (VT) that may be confused with either typical VT or supraventricular tachycardia (SVT). It is characterised by the absence of structural heart disease and classic electrocardiographic and electrophysiological features. It originates from the region of the posterior fascicle (or occasionally the anterior fascicle) of the left bundle branch and is partly propagated by the His-Purkinje network. It therefore produces QRS complexes of relatively short duration (0.11-0.14)s. (NCI) Def: A distinct subgroup of idiopathic ventricular tachycardia (VT) that may be confused with either typical VT or supraventricular tachycardia (SVT). It is characterized by the absence of structural heart disease and classic electrocardiographic and electrophysiological features. It originates from the region of the posterior fascicle (or occasionally the anterior fascicle) of the left bundle branch and is partly propagated by the His-Purkinje network. It therefore produces QRS complexes of relatively short duration (0.11-0.14)s. (NCI) 2009-07-06 20981 C71089 Definition Misspelling in Definition for 'U Waves' in SDTM-EGSTRESC codelist. Def: An electrocardiographic finding of a small hump following the T wave occuring during the final phase of Purkinje repolarization. (NCI) Def: An electrocardiographic finding of a small hump following the T wave occurring during the final phase of Purkinje repolarization. (NCI) 2009-07-06 20982 C71325 Definition Misspelling in Definition for 'Intermittent' in SDTM-FREQ codelist. Def: Periodically stoping and starting. (NCI) Def: Periodically stopping and starting. (NCI) 2009-07-06 20985 C74700 Definition Misspelling in Definition for 'Bite Cells' in SDTM-LBTEST, SDTM-LBTESTCD codelist. Def: A measurement of the bite cells (erthrocytes with the appearance of a bite having been removed, due to oxidative hemolysis) in a biological specimen . Def: A measurement of the bite cells (erythrocytes with the appearance of a bite having been removed, due to oxidative hemolysis) in a biological specimen . 2009-07-06 21561 C70526 Synonym Incorrect synonym of term 'GBq/ug' transcribed on CDISC CT spreadsheet. SY: Gigabecquerel per  microgram; MBq/ug, Megabecquerel per microgram SY: Gigabecquerel per microgram; MBq/ng, Megabecquerel per nanogram