Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist Change Summary Original New 2011-07-22 30898 II C25529 SY SDTM-AGEU Add SYs of Hour; hr - For compliance with CDASH and SDTM-UNIT codelist - - - SY: Hour; hr 2011-07-22 31459 I C17884; C16267; C16292; C20133; C44481; C16271; C16289; C16904; C17232; C16305; C16306; C17739; C18007; C20105; C16303; C16311; C16312; C16316; C16371; C16329; C16333; C16369; C16323; C16368; C16322; C16321; C16361; C83609; C16372; C16331; C16334; C16359; C16364; C16324; C16367; C16336; C20104; C16363; C16409; C16380; C16445; C17181; C16427; C16428; C16762; C16379; C17266; C16467; C16469; C16449; C16458; C16382; C16470; C16477; C44482; C16391; C16480; C17668; C16636; C16506; C16519; C16496; C16520; C16274; C16528; C16530; C16558; C20113; C17152; C16562; C16563; C16584; C16582; C17954; C16592; C16573; C17881; C16596; C17233; C16634; C64375; C26330; C16638; C16655; C16651; C16598; C16656; C16557; C16645; C16647; C16646; C16654; C16593; C16652; C16657; C16695; C20106; C16694; C16474; C16660; C16699; C16728; C16727; C44480; C16365; C16757; C16755; C16756; C16704; C16760; C16761; C16763; C16765; C16764; C64374; C20107; C16769; C16771; C16378; C16639; C17885; C16774; C16775; C16780; C16784; C16791; C16793; C17113; C16794; C17163; C16787; C16799; C16803; C16783; C16807; C83610; C16878; C16874; C16871; C16808; C16815; C16850; C16822; C17654; C16816; C16817; C16370; C64378; C16875; C17882; C16882; C16826; C16876; C16823; C16827; C16813; C16814; C16828; C16891; C16913; C16916; C16919; C16917; C16915; C16918; C16903; C16920; C16901; C16896; C16914; C16933; C16949; C16951; C16993; C16972; C16978; C17733; C16952; C17002; C17043; C16773; C17006; C16953; C20110; C16594; C17045; C17095; C17108; C17111; C17112; C17117; C64377; C17170; C17121; C17134; C20111; C17164; C17178; C17148; C17130; C16532; C17115; C17149; C17165; C17116; C17175; C17669; C17138; C17180; C17179; C17129; C17182; C17224; C16412; C17202; C17192; C17183; C17704; C17223; C17200; C17205; C17217; C17221; C17222; C17225; C17184; C17185; C17228; C17229; C20112; C17244; C17234; C17246; C17249; C17114; C17250; C17653; C17255; C17252; C17247; C17259; C17740; C17264; C17151; C17267; C17268; Definition SDTM-COUNTRY Add (NCI) to end of published definition of all values in SDTM-COUNTRY codelist. eg. PT: Aruba; Definition: Island in the Caribbean Sea, north of Venezuela. eg. PT: Aruba; Definition: Island in the Caribbean Sea, north of Venezuela. (NCI) 2011-07-22 31463 I C16333 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Benin Republic NCI PT: Benin 2011-07-22 31463 I C16361 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Bosnia-Herzegovina NCI PT: Bosnia and Herzegovina 2011-07-22 31463 I C16755 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Iran NCI PT: Iran, Islamic Republic of 2011-07-22 31463 I C16773 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: North Korea NCI PT: Korea, Democratic People's Republic of 2011-07-22 31463 I C16774 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: South Korea NCI PT: Korea, Republic of 2011-07-22 31463 I C16871 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Moldova NCI PT: Moldova, Republic of 2011-07-22 31463 I C16993 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Pitcairn Island NCI PT: Pitcairn 2011-07-22 31463 I C17111 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Russia NCI PT: Russian Federation 2011-07-22 31463 I C17182 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Syria NCI PT: Syrian Arab Republic 2011-07-22 31463 I C17184 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Taiwan NCI PT: Taiwan, Province of China 2011-07-22 31463 I C17185 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Tanzania NCI PT: Tanzania, United Republic of 2011-07-22 31463 I C17249 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Holy See NCI PT: Holy See (Vatican City State) 2011-07-22 31463 I C17252 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Vietnam NCI PT: Viet Nam 2011-07-22 31463 I C17255 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: United States Virgin Islands NCI PT: Virgin Islands, U.S. 2011-07-22 31463 I C17259 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Wallis and Futuna Islands NCI PT: Wallis and Futuna 2011-07-22 31463 I C17266 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Democratic Republic of the Congo NCI PT: Congo, the Democratic Republic of the 2011-07-22 31463 I C17653 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: British Virgin Islands NCI PT: Virgin Islands, British 2011-07-22 31463 I C17654 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Republic of Macedonia NCI PT: Macedonia, the Former Yugoslav Republic of 2011-07-22 31463 I C17881 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Federated States of Micronesia NCI PT: Micronesia, Federated States of 2011-07-22 31463 I C17954 NCI PT SDTM-COUNTRY Update NCI PT to mirror NCIt database. NCI PT: Falkland Islands NCI PT: Falkland Islands (Malvinas) 2011-07-22 31463 I C25370 NCI PT SDTM-DSCAT Update NCI PT to mirror NCIt database. NCIT PT: Exclusion NCIT PT: Exclusion Criteria 2011-07-22 31463 I C25532 NCI PT SDTM-DSCAT Update NCI PT to mirror NCIt database. NCIT PT: Inclusion NCIT PT: Inclusion Criteria 2011-07-22 31463 I C66797 NCI PT SDTM-DSCAT Update NCI PT to mirror NCIt database. NCIT PT: CDISC SDTM Category of Inclusion And Or Exclusion Terminology NCIT PT: CDISC SDTM Category for Inclusion And Or Exclusion Terminology 2011-07-22 30896 II C64496 SY SDTM-FREQ Add BD as a synonym to BID to be compliant with CDASH SY: Twice per day SY: Twice per day; BD 2011-07-22 31475 I C71127 Synonym SDTM-FREQ Remove period from end of SY SY: Every 2 weeks. SY: Every 2 weeks 2011-07-22 31288 I C81982 Definition SDTM-LBTEST; SDTM-LBTESTCD Typo in Definition. Def: A measurement of the cancer antigen 18-9 in a biological specimen. Def: A measurement of the cancer antigen 19-9 in a biological specimen. 2011-07-22 31003 I C33737 Concept Code SDTM-LOC Change concept code C33737 (TARSUS BONE) to C12796. C33737 was merged into C12796. Code: C33737 Code: C12796 2011-07-22 31412 I C12447 Term SDTM-LOC Duplicate Submission Values of "BASAL GANGLIA" in SDTM-LOC codelist - - - Remove one row. 2011-07-22 31413 I C12442 Term SDTM-LOC Duplicate Submission Values of "MEDULLA OBLONGATA" in SDTM-LOC codelist - - - Remove one row. 2011-07-22 31445 I C12782 Definition SDTM-LOC Errant hash mark in published definition. Definition: Any one of the paired bones, 12 on either side, extending from the thoracic vertebrae toward the median line on the ventral aspect of the trunk. The long curved bones which form the rib cage. Generally, ribs 1 to 7 are connected to the sternum' by their costal cartilages and are called true ribs, whereas ribs 8 to 12 are termed false ribs. (NCI) Definition: Any one of the paired bones, 12 on either side, extending from the thoracic vertebrae toward the median line on the ventral aspect of the trunk. The long curved bones which form the rib cage. Generally, ribs 1 to 7 are connected to the sternum by their costal cartilages and are called true ribs, whereas ribs 8 to 12 are termed false ribs. (NCI) 2011-07-22 31463 I C12331 NCI PT SDTM-LOC Update NCI PT to mirror NCIt database. NCI PT: Trigone of Bladder NCI PT: Bladder Trigone 2011-07-22 31463 I C12796 NCI PT SDTM-LOC Update NCI PT to mirror NCIt database. NCI PT: Tarsus Bone NCI PT: Tarsal Bone 2011-07-22 31463 I C83470 NCI PT SDTM-LOC Update NCI PT to mirror NCIt database. NCI PT: Appendeceal Tip NCI PT: Appendiceal Tip 2011-07-22 31463 I C93179 NCI PT SDTM-LOC Update NCI PT to mirror NCIt database. NCI PT: Upper Lobe of the Kidney NCI PT: Upper Lobe of Kidney 2011-07-22 31463 I C93180 NCI PT SDTM-LOC Update NCI PT to mirror NCIt database. NCI PT: Lower Lobe of the Kidney NCI PT: Lower Lobe of Kidney 2011-07-22 31447; 31458 I C12452 Definition SDTM-LOC Remove (NCI) from end of published definition. The largest and most lateral of the basal ganglia lying between the lateral medullary lamina of the globus pallidus and the external capsule. It is part of the neostriatum and forms part of the lentiform nucleus along with the globus pallidus. (MeSH) (NCI) The largest and most lateral of the basal ganglia lying between the lateral medullary lamina of the globus pallidus and the external capsule. It is part of the neostriatum and forms part of the lentiform nucleus along with the globus pallidus. (MeSH) 2011-07-22 31463 I C76241 NCI PT SDTM-MARISTAT Update NCI PT to mirror NCIt database. NCI PT: Interlocutory NCI PT: Interlocutory Marital Status 2011-07-22 31463 I C76348 NCI PT SDTM-MARISTAT Update NCI PT to mirror NCIt database. NCI PT: Marital Status Terminology NCI PT: CDISC SDTM Marital Status Terminology 2011-07-22 31463 I C16805 NCI PT SDTM-METHOD Update NCI PT to mirror NCIt database. NCI PT: Angiogram NCI PT: Lymphangiogram 2011-07-22 31463 I C17007 NCI PT SDTM-METHOD Update NCI PT to mirror NCIt database. NCI PT: PET-CT NCI PT: Positron Emission Tomography 2011-07-22 31463 I C48789 NCI PT SDTM-METHOD Update NCI PT to mirror NCIt database. NCI PT: Dual X-Ray Absorptometry NCI PT: Dual X-ray Absorptiometry 2011-07-22 31463 I C62298 NCI PT SDTM-METHOD Update NCI PT to mirror NCIt database. NCI PT: Percussion NCI PT: Dental Percussion 2011-07-22 31463 I C75583 NCI PT SDTM-METHOD Update NCI PT to mirror NCIt database. NCI PT: Slit Lamp Examination NCI PT: Slit-lamp Examination 2011-07-22 31463 I C85573 NCI PT SDTM-METHOD Update NCI PT to mirror NCIt database. NCI PT: Ascultation NCI PT: Auscultation 2011-07-22 31448 I C86465 Synonym SDTM-MICROORG Duplicate in SY column SY: ENTEROBACTER INTERMEDIUM; ENTEROBACTER INTERMEDIUS; KLUYVERA COCHLEAE; ENTEROBACTER INTERMEDIUM SY: ENTEROBACTER INTERMEDIUM; ENTEROBACTER INTERMEDIUS; KLUYVERA COCHLEAE 2011-07-22 31463 I C62589 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Gram Positive Bacillus NCI PT: Gram-Positive Rod 2011-07-22 31463 I C86881 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Escherichia coli and strain O111 NCI PT: Escherichia coli strain O111 2011-07-22 31463 I C86882 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Escherichia coli and strain O157 NCI PT: Escherichia coli strain O157 2011-07-22 31463 I C86883 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Escherichia coli and strain O157:H7 NCI PT: Escherichia coli strain O157:H7 2011-07-22 31463 I C86884 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Escherichia coli and strain O26 NCI PT: Escherichia coli strain O26 2011-07-22 31463 I C91844 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Salmonella enterica subsp. diarizonae NCI PT: Salmonella enterica subsp diarizonae 2011-07-22 31463 I C91845 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Salmonella enterica subsp. houtenae NCI PT: Salmonella enterica subsp houtenae 2011-07-22 31463 I C91846 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Salmonella enterica subsp. indica NCI PT: Salmonella enterica subsp indica 2011-07-22 31463 I C91847 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Salmonella enterica subsp. salamae NCI PT: Salmonella enterica subsp salamae 2011-07-22 31463 I C91848 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Streptococcus dysgalactiae subsp. dysgalactiae NCI PT: Streptococcus dysgalactiae subsp dysgalactiae 2011-07-22 31463 I C91849 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Treponema pallidum subsp. pallidum NCI PT: Treponema pallidum subsp pallidum 2011-07-22 31463 I C91850 NCI PT SDTM-MICROORG Update NCI PT to mirror NCIt database. NCI PT: Treponema pallidum subsp. endemicum NCI PT: Treponema pallidum subsp endemicum 2011-07-22 31463 I C85495 NCI PT SDTM-MSRESCAT Update NCI PT to mirror NCIt database. - - - NCI PT: CDISC SDTM Microbiology Susceptibility Testing Result Category Terminology 2011-07-22 30897 II C71205; C71211; C67406; C48152 SY SDTM-PKUNIT Addition of synonyms for compliance between SDTM-PKUNIT, SDTM-UNIT, and CDASH codelists. See published spreadsheet 2011-06-10 for existing synonyms. C71205-add mcg/day as a synonym to 'ug/day'; C71211-add mcg/min as a synonym to 'umol/min'; C67406-add mcmol/day as a synonym to 'umol/day'; C48152-add mcg as a synonym to 'ug'. 2011-07-22 31463 I C73755 NCI PT SDTM-PKUNIT; SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: Liter per Kilogram per Day NCI PT: Milliliter per Gram per Day 2011-07-22 31460 I C38192; C38193; C38194; C38197; C38198; C38200; C38203; C38205; C38206; C38207; C38208; C38209; C38210; C38211; C38212; C38215; C38216; C38217; C38218; C38219; C38220; C38221; C38222; C38223; C38224; C38225; C38226; C38227; C38228; C38229; C38230; C38231; C38232; C38233; C38234; C38235; C38238; C38239; C38240; C38241; C38242; C38243; C38245; C38246; C38247; C38249; C38250; C38251; C38252; C38253; C38254; C38255; C38256; C38257; C38258; C38259; C38260; C38261; C38262; C38263; C38264; C38265; C38266; C38267; C38268; C38269; C38270; C38271; C38272; C38273; C38274; C38276; C38277; C38278; C38279; C38280; C38281; C38282; C38283; C38284; C38285; C38286; C38287; C38288; C38289; C38290; C38291; C38292; C38293; C38294; C38295; C38296; C38297; C38298; C38299; C38300; C38301; C38304; C38305; C38307; C38308; C38309; C38310; C38311; C38312; C38313; C38633; C38675; C38676; C38677; C48623 Definition SDTM-ROUTE Add space between period and (FDA) at end of all FDA definitions within this codelist. eg. PT: AURICULAR (OTIC); Definition: Administration to or by way of the ear.(FDA) eg. PT: AURICULAR (OTIC); Definition: Administration to or by way of the ear. (FDA) 2011-07-22 31463 I C25218 NCI PT SDTM-SOC Update NCI PT to mirror NCIt database. NCI PT: Procedure NCI PT: Intervention or Procedure 2011-07-22 31463 I C3959 NCI PT SDTM-SOC Update NCI PT to mirror NCIt database. NCI PT: Liver and Biliary Tract Disorder NCI PT: Hepatobiliary Disorder 2011-07-22 31463 I C38008 NCI PT SDTM-STENRF Update NCI PT to mirror NCIt database. NCI PT: Status Post NCI PT: Post 2011-07-22 30861 II C49692 Definition SDTM-TSPARM C49692 - Modify definition to The planned number of subjects entered in a clinical trial Def: The number of subjects entered in a clinical trial. (NCI) Def: The planned number of subjects entered in a clinical trial. 2011-07-22 30869 III C49697 Definition SDTM-TSPARM Change definition for LENGTH/Trial Length. Def: The anticipated length of a clinical trial measured as a unit of time. (NCI) Def: Planned length of observation for a single subject. 2011-07-22 30899 II C25529 SY SDTM-UNIT SY of hr needs to be added - For compliance with CDASH and SDTM-AGEU codelist SY: Hour SY: Hour; hr 2011-07-22 31451 I C70526 Synonym SDTM-UNIT Comma in SY list. Change to semi-colon. SY: Gigabecquerel per microgram; MBq/ng, Megabecquerel per nanogram; GBq/mcg SY: Gigabecquerel per microgram; MBq/ng; Megabecquerel per nanogram; GBq/mcg 2011-07-22 31455 I C29846 Definition SDTM-UNIT Definition changes: C29846 - Add space between period and (NCI) Definition: One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks.(NCI) Definition: One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks. (NCI) 2011-07-22 31455 I C49668 Definition SDTM-UNIT Definition changes: C49668 - Add period at end of sentence. Definition: A basic unit of length equal to one hundredth of a meter or approximately 0.393 700 787 inch (NCI) Definition: A basic unit of length equal to one hundredth of a meter or approximately 0.393 700 787 inch. (NCI) 2011-07-22 31461 I C25529; C25613; C28251; C29844; C42554; C49670; C49673; C49674 Definition SDTM-UNIT Add space between period and (NCI) at end of definition. PT: HOURS; Definition: A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day.(NCI) PT: HOURS; Definition: A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day. (NCI) 2011-07-22 31462 I C67069 Definition SDTM-UNIT Add (NCI) to end of definition Definition: Every week. Definition: Every week. (NCI) 2011-07-22 31463 I C67069 NCI PT SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: /week NCI PT: Weekly 2011-07-22 31463 I C67372 NCI PT SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: g/day NCI PT: Gram per 24 Hours 2011-07-22 31463 I C71202 NCI PT SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: Kilo United States Pharmacopoeia Unit NCI PT: Kilo United States Pharmacopeia Unit 2011-07-22 31463 I C71321 NCI PT SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: Fingertip Unit NCI PT: Fingertip Dosing Unit 2011-07-22 31463 I C73770 NCI PT SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: um2 NCI PT: Square Micrometer 2011-07-22 31463 I C77534 NCI PT SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: AFU NCI PT: Arbitrary Fluorescence Units 2011-07-22 31463 I C92613 NCI PT SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: nmol/mL/min NCI PT: Nanomole per Minute per Milliliter 2011-07-22 31463 I C92615 NCI PT SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: kN/cm2 NCI PT: Kilonewton per Centimeter Squared 2011-07-22 31463 I C92616 NCI PT SDTM-UNIT Update NCI PT to mirror NCIt database. NCI PT: mEq/mmol NCI PT: Milliequivalent per Milliimole 2011-07-22 na I C75533 Synonym SDTM-TOXGR Change colon in synonym column to semi-colon SY: ABSENT; Grade 0: 0 SY: ABSENT; Grade 0; 0