Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist Change Summary Original New 2011-12 31464 II C48660 Synonym SDTM-ACN Add 'Not Applicable' as a SY SY: NA SY: NA; Not Applicable 2011-12 31476 II C66781 Definition SDTM-AGEU Change definition of Codelist Term to allow SEND usage. Def: Those units of time that are routinely used to express the age of a person. (NCI) Def: Those units of time that are routinely used to express the age of a subject. 2011-12 31452 III C64374 Submission Value SDTM-COUNTRY Change CDISC submission value from JRE to JEY. ISO update. PT: JRE PT: JEY 2011-12 31453 III C64377 Submission Value SDTM-COUNTRY Change CDISC submission value from SCG to SRB. ISO update. PT: SCG PT: SRB 2011-12 31454 II C16695 Synonym SDTM-COUNTRY Remove HKG as a synonym. HKG is the submission value and we don't put the three letter ISO codes in as synonyms. SY: HKG; HONG KONG SY: HONG KONG 2011-12 31449 II C66788 Synonym SDTM-DICTNAM Remove 'Name of Dictionary' from synonym of codelist concept. SY: Dictionary Name; Name of Dictionary SY: Dictionary Name 2011-12 P7-P8 III C99074 Codelist SDTM-DIR Addition of a new Directionality Codelist for SDTM and SEND. - - - Addition of 29 terms to a new codelist. 2011-12 31472 II C49619 Synonym SDTM-DOMAIN Remove TE as a synonym. TE is the Submission value. SY: TE; Trial Elements SY: Trial Elements 2011-12 P7-P8 II C95099 Submission Value SDTM-DOMAIN Rename duplicate two-letter domain name. PT: ST PT: SJ 2011-12 P7-P8 III C97197 Submission Values SDTM-DOSFRM Addition of new terminology to existing codelist. - - - PT: CAPLET 2011-12 P7-P8 III C99079 Codelist SDTM-EPOCH Addition of a new Epoch codelist for SDTM. - - - Addition of 5 terms to a new codelist. 2011-12 P7-P8 III MULTIPLE Submission Values SDTM-FREQ Addition of new terminology to existing codelist. See published spreadsheet 2011-07-22 Addition of 17 terms to an existing codelist. 2011-12 31474 II C67069 Synonym SDTM-FREQ Addition of synonym in SDTM-FREQ codelist due to use of terms in other codelists. SY: Every week SY: Every week; Per Week 2011-12 P7-P8 III C99076 Codelist SDTM-INTMODEL Addition of a new Intervention Model codelist for SDTM. - - - Addition of 4 terms to a new codelist. 2011-12 P7-P8 III C99078 Codelist SDTM-INTTYPE Addition of a new Intervention Type codelist for SDTM. - - - Addition of 9 terms to a new codelist. 2011-12 P7-P8 III C99073 Codelist SDTM-LAT Addition of a new Laterality Codelist for SDTM and SEND. - - - Addition of 7 terms to a new codelist. 2011-12 31432; 31433 II C92270 Synonym SDTM-LBTEST; SDTM-LBTESTCD Add "Extractable Nuclear Antigen Antibody" as a synonym. SY: Anti-ENA SY: Anti-ENA; Extractable Nuclear Antigen Antibody P7-P8 III MULTIPLE Submission Values SDTM-LBTEST; SDTM-LBTESTCD Addition of a new terms to SDTM-LBTEST and SDTM-LBTESTCD codelist. See published spreadsheet 2011-07-22 Addition of 51 terms to an existing codelist. 2011-12 P7-P8 II C64850 Synonym SDTM-LBTEST; SDTM-LBTESTCD Addition of synonym SY: Hepatitis B Virus Surface Antigen SY: HBsAg; Hepatitis B Virus Surface Antigen 2011-12 P7-P8 II C64857 Synonym SDTM-LBTEST; SDTM-LBTESTCD Addition of synonym SY: Phosphate; Phosphorus SY: Phosphate; Phosphorus; Inorganic Phosphate 2011-12 P7-P8 II C74711 Synonym SDTM-LBTEST; SDTM-LBTESTCD Addition of synonym SY: Hepatitis B Virus Surface Antibody SY: Anti-HBs; HBsAb; Hepatitis B Virus Surface Antibody 2011-12 P7-P8 II C92291 Synonym SDTM-LBTEST; SDTM-LBTESTCD Addition of synonym SY: Monoclonal Protein; Paraprotein SY: Monoclonal Immunoglobulin Protein; Paraprotein 2011-12 P7-P8 II C96636 Synonym SDTM-LBTEST; SDTM-LBTESTCD Addition of synonym SY: Target Cells SY: Leptocytes; Target Cells 2011-12 P7-P8 III C64434 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the pancreatic enzyme amylase in a biological specimen. Def: A measurement of the total enzyme amylase in a biological specimen. 2011-12 P7-P8 III C74698 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the round epithelial cells present in a urine specimen. Def: A measurement of the round epithelial cells present in a biological specimen. 2011-12 P7-P8 III C74718 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the amount of iron needed to fully saturate the transferrin in a serum specimen. Def: A measurement of the amount of iron needed to fully saturate the transferrin in a biological specimen. 2011-12 P7-P8 III C74753 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A relative measurement (ratio or percentage) (ratio) of the blood urea nitrogen (BUN) to the creatinine in a blood specimen. Def: A relative measurement (ratio or percentage) (ratio) of the blood urea nitrogen (BUN) to the creatinine in a biological specimen. 2011-12 P7-P8 III C74754 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the hippuric acid crystals present in a urine specimen. Def: A measurement of the hippuric acid crystals present in a biological specimen. 2011-12 P7-P8 III C74755 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the sulfa crystals present in a urine specimen. Def: A measurement of the sulfa crystals present in a biological specimen. 2011-12 P7-P8 III C74756 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the triple phosphate crystals present in a urine specimen. Def: A measurement of the triple phosphate crystals present in a biological specimen. 2011-12 P7-P8 III C74757 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the unclassifiable crystals present in a urine specimen. Def: A measurement of the unclassifiable crystals present in a biological specimen. 2011-12 P7-P8 III C74761 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A relative measurement (ratio or percentage) of the albumin to the creatinine in a urine specimen. Def: A relative measurement (ratio or percentage) of the albumin to the creatinine in a biological specimen. 2011-12 P7-P8 III C74762 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the bacterial casts present in a urine specimen. Def: A measurement of the bacterial casts present in a biological specimen. 2011-12 P7-P8 III C74764 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the cellular (white blood cell, red blood cell, epithelial and bacterial) casts present in a urine specimen. Def: A measurement of the cellular (white blood cell, red blood cell, epithelial and bacterial) casts present in a biological specimen. 2011-12 P7-P8 III C74765 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the coarse granular casts present in a urine specimen. Def: A measurement of the coarse granular casts present in a biological specimen. 2011-12 P7-P8 III C74766 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the fatty casts present in a urine specimen. Def: A measurement of the fatty casts present in a biological specimen. 2011-12 P7-P8 III C74768 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the granular (coarse and fine) casts present in a urine specimen. Def: A measurement of the granular (coarse and fine) casts present in a biological specimen. 2011-12 P7-P8 III C74769 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the fine granular casts present in a urine specimen. Def: A measurement of the fine granular casts present in a biological specimen. 2011-12 P7-P8 III C74770 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the hyaline casts present in a urine specimen. Def: A measurement of the hyaline casts present in a biological specimen. 2011-12 P7-P8 III C74771 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the mixed (the cast contains a mixture of cell types) casts present in a urine specimen. Def: A measurement of the mixed (the cast contains a mixture of cell types) casts present in a biological specimen. 2011-12 P7-P8 III C74772 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the red blood cell casts present in a urine specimen. Def: A measurement of the red blood cell casts present in a biological specimen. 2011-12 P7-P8 III C74773 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the squamous epithelial cells present in a urine specimen. Def: A measurement of the squamous epithelial cells present in a biological specimen. 2011-12 P7-P8 III C74774 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the squamous transitional epithelial cells present in a urine specimen. Def: A measurement of the squamous transitional epithelial cells present in a biological specimen. 2011-12 P7-P8 III C74775 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the tubular epithelial cells present in a urine specimen. Def: A measurement of the tubular epithelial cells present in a biological specimen. 2011-12 P7-P8 III C74776 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the unclassifiable casts present in a urine specimen. Def: A measurement of the unclassifiable casts present in a biological specimen. 2011-12 P7-P8 III C74777 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the waxy casts present in a urine specimen. Def: A measurement of the waxy casts present in a biological specimen. 2011-12 P7-P8 III C74778 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the white blood cell casts present in a urine specimen. Def: A measurement of the white blood cell casts present in a biological specimen. 2011-12 P7-P8 III C74779 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the epithelial cell casts present in a urine specimen. Def: A measurement of the epithelial cell casts present in a biological specimen. 2011-12 P7-P8 III C74894 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: The ratio of albumin to globulin in a blood specimen. Def: The ratio of albumin to globulin in a biological specimen. 2011-12 P7-P8 III C74897 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the Vitamin B17 in a serum specimen. Def: A measurement of the Vitamin B17 in a biological specimen. 2011-12 P7-P8 III C80166 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A relative measurement (ratio or percentage) of the alpha glutathione-S-transferase to creatinine in a urine specimen. Def: A relative measurement (ratio or percentage) of the alpha glutathione-S-transferase to creatinine in a biological specimen. 2011-12 P7-P8 III C80171 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A relative measurement (ratio or percentage) of total cholesterol to high-density lipoprotein cholesterol (HDL-C) in a blood specimen. Def: A relative measurement (ratio or percentage) of total cholesterol to high-density lipoprotein cholesterol (HDL-C) in a biological specimen. 2011-12 P7-P8 III C80187 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the high-density lipoprotein (HDL) cholesterol subclass 2 in a blood specimen. Def: A measurement of the high-density lipoprotein (HDL) cholesterol subclass 2 in a biological specimen. 2011-12 P7-P8 III C80188 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the high-density lipoprotein (HDL) cholesterol subclass 3 in a blood specimen. Def: A measurement of the high-density lipoprotein (HDL) cholesterol subclass 3 in a biological specimen. 2011-12 P7-P8 III C81947 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the oval-shaped fat bodies in a biological specimen. Def: A measurement of the oval-shaped fat bodies, usually renal proximal tubular cells with lipid aggregates in the cytoplasm, in a biological specimen. 2011-12 P7-P8 III C81962 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the range of platelet sizes in a blood specimen. Def: A measurement of the range of platelet sizes in a biological specimen. 2011-12 P7-P8 III C81974 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the antibody or complement-coated erythrocytes in a blood specimen in vivo. Def: A measurement of the antibody or complement-coated erythrocytes in a biological specimen in vivo. 2011-12 P7-P8 III C82044 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the indican present in a urine specimen. Def: A measurement of the indican present in a biological specimen. 2011-12 P7-P8 III C92251 Definition SDTM-LBTEST; SDTM-LBTESTCD Definition update. Def: A measurement of the transitional epithelial cells present in a urine specimen. Def: A measurement of the transitional epithelial cells present in a biological specimen. 2011-12 P7-P8 III C92241 Submission Value SDTM-LBTEST; SDTM-LBTESTCD Shorten submission value to 40 characters or less. PT: Mycobacterium tuberculosis IFN Gamma Response PT: M. tuberculosis IFN Gamma Response 2011-12 P7-P8 III C92533 Submission Value SDTM-LBTEST; SDTM-LBTESTCD Shorten submission value to 40 characters or less. PT: Soluble Vascular Cell Adhesion Molecule 1 PT: Soluble Vasc Cell Adhesion Molecule 1 2011-12 P7-P8 III MULTIPLE Submission Values SDTM-LOC Addition of new terminology to existing codelist. See published spreadsheet 2011-07-22 Addition of 6 terms to an existing codelist. 2011-12 31466 II C12290 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Mandible SY: Bone, Mandibular; Mandible; Inferior Maxillary Bone; Jaw 2011-12 31466 II C12292 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: External Ear SY: Auricle; External Ear 2011-12 31466 II C12311 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Cervix Uteri SY: Cervix Uteri; Uterine Cervix 2011-12 31466 II C12347 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Orbit SY: Eye Socket; Ocular Orbit; Orbit; Orbital Cavity 2011-12 31466 II C12381 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Cecal; Cecum 2011-12 31466 II C12399 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Hypophysis Cerebri; Hypophysis 2011-12 31466 II C12401 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Eye SY: Eye; Eyeball 2011-12 31466 II C12405 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Uterus SY: Uterus; Womb 2011-12 31466 II C12408 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Vulva SY: External Genitalia; Vulva 2011-12 31466 II C12412 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Testis SY: Testicle; Testis 2011-12 31466 II C12428 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Trachea SY: Trachea; Windpipe 2011-12 31466 II C12439 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Brain SY: Brain; Nervous System, Brain 2011-12 31466 II C12441 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Brain Stem 2011-12 31466 II C12444 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Hippocampus 2011-12 31466 II C12453 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Substantia Nigra 2011-12 31466 II C12458 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Hypothalamus 2011-12 31466 II C12470 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Skin SY: Integument; Skin 2011-12 31466 II C12499 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Internal Ear SY: Cochlea; Internal Ear; Labyrinth 2011-12 31466 II C12510 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Mesencephalon SY: Mesencephalon; Midbrain 2011-12 31466 II C12664 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Abdominal Cavity SY: Abdomen; Abdominal Cavity 2011-12 31466 II C12683 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Bronchus SY: Bronchi; Bronchus 2011-12 31466 II C12694 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Choroid Plexus 2011-12 31466 II C12713 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Eyelid SY: Eyelid; Palpebra 2011-12 31466 II C12717 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Femur SY: Bone, Femoral; Femur 2011-12 31466 II C12719 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Ganglion SY: Ganglia; Ganglion; Neural Ganglion 2011-12 31466 II C12727 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Heart SY: Cardiac; Heart 2011-12 31466 II C12731 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Humerus SY: Bone, Humeral; Humerus 2011-12 31466 II C12743 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Lens SY: Crystalline Lens; Lens; Lens Of Eye; Ocular Lens 2011-12 31466 II C12763 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Paranasal Sinus SY: Accessory Sinuses; Nasal Cavity; Nasal Sinuses; Paranasal Sinus 2011-12 31466 II C12767 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Pelvis SY: Pelvic Cavity; Pelvis 2011-12 31466 II C12777 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Radius Bone SY: Radius; Radius Bone 2011-12 31466 II C12783 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Scapula SY: Scapula; Shoulder Blade 2011-12 31466 II C12787 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Seminal Sacs 2011-12 31466 II C12789 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Skull SY: Bone, Cranial; Cranium; Skull 2011-12 31466 II C12793 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Sternum SY: Sterna; Sternum 2011-12 31466 II C12796 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Tarsus Bone SY: Bone, Tarsal; Tarsus Bone; Tarsus 2011-12 31466 II C12905 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Thoracic Cavity 2011-12 31466 II C13044 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Joint SY: Articulation; Joint 2011-12 31466 II C13071 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Face SY: Face; Facial 2011-12 31466 II C28401 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: - - - SY: Olfactory Bulb 2011-12 31466 II C32286 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Cephalic Vein SY: Cephalic Vein; Vena Cephalica 2011-12 31466 II C32622 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Foot SY: Feet; Foot 2011-12 31466 II C32677 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Gingiva SY: Gingiva; Gum 2011-12 31466 II C32742 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Hip Joint SY: Coxofemoral Joint; Hip Joint 2011-12 31466 II C32898 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Knee Joint SY: Knee Joint; Tibiofemoral Joint 2011-12 31466 II C33287 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Pelvic Bone SY: Pelvic Bone; Pelvis 2011-12 31466 II C33343 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Portal Vein SY: Hepatic Portal Vein; Portal Vein 2011-12 31466 II C33718 Synonym SDTM-LOC Addition of synonyms in SDTM-LOC codelist due to use of terms in other codelists. SY: Synovial Fluid SY: Synovial Fluid; Synovia 2011-12 31471 II C48275 Synonym SDTM-OUT Addition of synonym in codelist due to use of terms in other codelists. SY: Grade 5; 5 SY: Grade 5; 5; FATAL 2011-12 31467 II C48153 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. mcL mcL; Microliter; mm3 2011-12 31467 II C64387 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. Micromole per Milliliter; Millimole per Liter; mol/m3; Mole per Cubic Meter; mmol/L Micromole per Milliliter; Millimole per Liter; mol/m3; Mole per Cubic Meter; mmol/L; mcmol/mL; nmol/uL; umol/mL 2011-12 31467 II C64566 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. Gram per Milliliter; Kilogram per Liter Kilogram per Liter; g/mL; Gram per Milliliter; gram/mL; kg/L; mg/uL 2011-12 31467 II C64572 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. g/m3; Gram per Cubic Meter; mg/L; Microgram per Milliliter; Milligram per Liter g/m3; Gram per Cubic Meter; mg/L; Microgram per Milliliter; Milligram per Liter; mcg/mL; ng/uL; ug/mL 2011-12 31467 II C67306 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL; mcg/L 2011-12 31467 II C67394 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. Micrograms per Hour Micrograms per Hour; mcg/h 2011-12 31467 II C67396 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. Microgram per Kilogram; mcg/kg mcg/kg; Microgram per Kilogram; ng/g; ug/kg 2011-12 31467 II C67405 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. mIU/L; mcIU/mL; uIU/mL Micro-International Unit per milliliter; mIU/L; mcIU/mL; uIU/mL 2011-12 31467 II C69073 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. - - - mL/sec 2011-12 31467 II C73755 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. mL/g/day; uL/mg/day; L/day/kg; mL/day/g; uL/day/mg; L/kg/d Milliliter per Gram per Day; mL/g/day; uL/mg/day; L/day/kg; mL/day/g; uL/day/mg; L/kg/d 2011-12 31467 II C73758 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. - - - Milliliter per Kilogram per Day 2011-12 31467 II C73759 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. - - - Milliliter per Kilogram per Hour 2011-12 31467 II C73760 Synonym SDTM-PKUNIT Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist. uL/g/min; mL/min/kg; uL/min/g; mL/kg/min Milliliter per Kilogram per Minute; uL/g/min; mL/min/kg; uL/min/g; mL/kg/min 2011-12 P7-P8 III C99075 Codelist SDTM-PORTOT Addition of a new Portion Totality Codelist for SDTM and SEND. - - - Addition of 6 terms to a new codelist. 2011-12 P7-P8 II C70719 Synonym SDTM-SPCCND Addition of a synonym SY: Specimen at Room Temperature SY: Ambient Temperature; Specimen at Room Temperature 2011-12 P7-P8 III C98744 Submission Values SDTM-SPECOND Addition of new terminology to existing codelist. - - - PT: ICTERIC 2011-12 31468 II C12692 Synonym SDTM-SPECTYPE Addition of synonyms in SDTM-SPECTYPE codelist due to use of terms in other codelists. - - - SY: CSF 2011-12 31468 II C13188 Synonym SDTM-SPECTYPE Addition of synonyms in SDTM-SPECTYPE codelist due to use of terms in other codelists. - - - SY: Aqua Amnii 2011-12 31468 II C13325 Synonym SDTM-SPECTYPE Addition of synonyms in SDTM-SPECTYPE codelist due to use of terms in other codelists. - - - SY: Sera 2011-12 31468 II C77666 Synonym SDTM-SPECTYPE Addition of synonyms in SDTM-SPECTYPE codelist due to use of terms in other codelists. SY: Vomit SY: Emesis; Vomit 2011-12 P7-P8 III C99077 Codelist SDTM-STYPE Addition of a new Study Type codelist for SDTM. - - - Addition of 3 terms to a new codelist. 2011-12 31450 II C66785 Synonym SDTM-TCNTRL Remove 'Type of Control' from synonym of codelist concept. SY: Control Type; Type of Control SY: Control Type 2011-12 31469 II C41337 Synonym SDTM-TOXGR Addition of synonym in SDTM-TOXGR codelist due to use of terms in other codelists. SY: Grade 4; 4 SY: Grade 4; 4; LIFE THREATENING 2011-12 31469 II C48275 Synonym SDTM-TOXGR Addition of synonym in SDTM-TOXGR codelist due to use of terms in other codelists. SY: Grade 5; 5 SY: Grade 5; 5; FATAL P7-P8 III MULTIPLE Submission Values SDTM-TSPARM; SDTM-TSPARMCD Addition of new terminology to existing codelist. See published spreadsheet 2011-07-22 Addition of 20 terms to an existing codelist. 2011-12 P7-P8 II C49692 Synonym SDTM-TSPARM; SDTM-TSPARMCD Addition of synonyms. SY: Planned Number of Subjects SY: Planned Number of Subjects; Planned Enrollment; Target Enrollment; Anticipated Enrollment 2011-12 P7-P8 III C49692 Definition SDTM-TSPARM; SDTM-TSPARMCD Definition update. Def: The number of subjects entered in a clinical trial. (NCI) Def: The planned number of subjects to be entered in a clinical trial. 2011-12 P7-P8 III C50400 Term SDTM-TSPARM; SDTM-TSPARMCD Delete this parameter from the CDISC TSPARM and TSPARMCD codelist. PT: AGEU/Age Unit - - - 2011-12 P7-P8 III MULTIPLE Submission Values SDTM-TTYPE Addition of new terminology to existing codelist. See published spreadsheet 2011-07-22 Addition of 3 terms to an existing codelist. 2011-12 P7-P8 II C49667 Definition SDTM-TTYPE Definition update. Def: A study of the relative safety of treatment of a disease. Usually this is a Phase I or II trial. (NCI). Def: A study that assesses the medical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, including adverse events, vital signs, physical exam, laboratory tests. 2011-12 P7-P8 III MULTIPLE Submission Values SDTM-UNIT Addition of new terminology to existing codelist. See published spreadsheet 2011-07-22 Addition of 20 terms to an existing codelist. 2011-12 P7-P8 II C42576 Synonym SDTM-UNIT Addition of synonym SY: Kilogram per Cubic Meter; g/L; Gram per Liter; ug/uL; Microgram per Microliter; Milligram per Milliliter SY: Kilogram per Cubic Meter; Gram per Liter; ug/uL; Microgram per Microliter; Milligram per Milliliter; kg/m3; mg/mL; g/L 2011-12 P7-P8 II C64572 Synonym SDTM-UNIT Addition of synonym SY: Gram per Cubic Meter; ug/mL; Microgram per Milliliter; mg/L; Milligram per Liter Gram per Cubic Meter; ug/mL; Microgram per Milliliter; Milligram per Liter; g/m3 2011-12 P7-P8 II C67335 Synonym SDTM-UNIT Addition of synonym SY: Million International Units SY: Million International Units; Million IU 2011-12 P7-P8 II C68858 Synonym SDTM-UNIT Addition of synonym SY: Standard Cubic Meter SY: Standard Cubic Meter; m3 2011-12 P7-P8 II C68895 Synonym SDTM-UNIT Addition of synonym SY: Thousand Colony Forming Units SY: Thousand Colony Forming Units; Thousand CFU 2011-12 P7-P8 II C68896 Synonym SDTM-UNIT Addition of synonym SY: Million Colony Forming Units SY: Million Colony Forming Units; Million CFU 2011-12 P7-P8 II C68897 Synonym SDTM-UNIT Addition of synonym SY: Billion Colony Forming Units SY: Billion Colony Forming Units; Billion CFU 2011-12 P7-P8 II C68899 Synonym SDTM-UNIT Addition of synonym SY: Thousand Colony Forming Units per Gram SY: Thousand Colony Forming Units per Gram; Thousand CFU/g 2011-12 P7-P8 II C68900 Synonym SDTM-UNIT Addition of synonym SY: Million Colony Forming Units per Gram SY: Million Colony Forming Units per Gram; Million CFU/g 2011-12 P7-P8 II C68901 Synonym SDTM-UNIT Addition of synonym SY: Billion Colony Forming Units per Gram SY: Billion Colony Forming Units per Gram; Billion CFU/g 2011-12 P7-P8 II C68903 Synonym SDTM-UNIT Addition of synonym SY: Thousand Colony Forming Units per Milliliter SY: Thousand Colony Forming Units per Milliliter; Thousand CFU/mL 2011-12 P7-P8 II C68904 Synonym SDTM-UNIT Addition of synonym SY: Million Colony Forming Units per Milliliter SY: Million Colony Forming Units per Milliliter; Million CFU/mL 2011-12 P7-P8 II C68905 Synonym SDTM-UNIT Addition of synonym SY: Billion Colony Forming Units per Milliliter SY: Billion Colony Forming Units per Milliliter; Billion CFU/mL 2011-12 P7-P8 II C71190 Synonym SDTM-UNIT Addition of synonym SY: Thousand Organisms per Gram SY: Thousand Organisms per Gram; Thousand Organisms/g 2011-12 P7-P8 II C71191 Synonym SDTM-UNIT Addition of synonym SY: Million Organisms per Gram SY: Million Organisms per Gram; Million Organisms/g 2011-12 P7-P8 II C71192 Synonym SDTM-UNIT Addition of synonym SY: Billion Organisms per Gram SY: Billion Organisms per Gram; Billion Organisms/g 2011-12 P7-P8 II C71193 Synonym SDTM-UNIT Addition of synonym SY: Million Organisms per Milligram SY: Million Organisms per Milligram; Million Organisms/mg 2011-12 P7-P8 II C71194 Synonym SDTM-UNIT Addition of synonym SY: Billion Organisms per Milligram SY: Billion Organisms per Milligram; Billion Organisms/mg 2011-12 P7-P8 II C71195 Synonym SDTM-UNIT Addition of synonym SY: Thousand Organisms per Milliliter SY: Thousand Organisms per Milliliter; Thousand Organisms/mL 2011-12 P7-P8 II C71196 Synonym SDTM-UNIT Addition of synonym SY: Million Organisms per Milliliter SY: Million Organisms per Milliliter; Million Organisms/mL 2011-12 P7-P8 II C71197 Synonym SDTM-UNIT Addition of synonym SY: Billion Organisms per Milliliter SY: Billion Organisms per Milliliter; Billion Organisms/mL 2011-12 31474 II C67069 Synonym SDTM-UNIT Addition of synonym in SDTM-UNIT codelist due to use of terms in other codelists. SY: Per Week SY: Every week; Per Week 2011-12 31470 II C42576 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: g/L; Gram per Liter; kg/m3; Kilogram per Cubic Metre; Microgram per Microliter; Milligram per Milliliter; ug/uL SY: g/L; Gram per Liter; kg/m3; Kilogram per Cubic Metre; Microgram per Microliter; Milligram per Milliliter; ug/uL; mg/mL 2011-12 31470 II C48520 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Package Dosing Unit SY: Package Dosing Unit; Pack Dosing Unit 2011-12 31470 II C64387 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Millimole per Liter; umol/mL; Micromole per Milliliter; mol/m3; Mole per Cubic Meter SY: Millimole per Liter; umol/mL; Micromole per Milliliter; mol/m3; Mole per Cubic Meter; mcmol/mL; mmol/L; nmol/uL 2011-12 31470 II C64566 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Kilogram per Liter; g/mL; Gram per Milliliter SY: Kilogram per Liter; g/mL; Gram per Milliliter; gram/mL; kg/L; mg/uL 2011-12 31470 II C64572 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Gram per Cubic Meter; ug/mL; Microgram per Milliliter; mg/L; Milligram per Liter; g/m3 SY: Gram per Cubic Meter; ug/mL; Microgram per Milliliter; mg/L; Milligram per Liter; g/m3; mcg/mL; ng/uL 2011-12 31470 II C64783 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Gram per Deciliter SY: Gram per Deciliter; g% 2011-12 31470 II C67015 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Milligram per Deciliter SY: Milligram per Deciliter; mg% 2011-12 31470 II C67306 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L SY: mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL 2011-12 31470 II C67396 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: ug/kg; Microgram per Kilogram SY: ug/kg; Microgram per Kilogram; ng/g 2011-12 31470 II C48153 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Microliter SY: mcL; Microliter; mm3 2011-12 31470 II C73755 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Milliliter per Gram per Day SY: Milliliter per Gram per Day; mL/g/day; uL/mg/day; L/day/kg; mL/day/g; uL/day/mg; L/kg/d 2011-12 31470 II C67306 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Microgram per Liter; mg/m3; Milligram per Cubic Meter; ng/mL; Nanogram per Milliliter; mcg/L SY: mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL; mcg/L 2011-12 31470 II C67405 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Micro-International Unit per milliliter SY: Micro-International Unit per milliliter; mIU/L; mcIU/mL; uIU/mL 2011-12 31470 II C73760 Synonym SDTM-UNIT Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist. SY: Milliliter per Kilogram per Minute SY: Milliliter per Kilogram per Minute; uL/g/min; mL/min/kg; uL/min/g; mL/kg/min 2011-12 P7-P8 III C42576 Submission Value SDTM-UNIT CDISC submission value update. PT: kg/m3 PT: g/L 2011-12 P7-P8 III C64572 Submission Value SDTM-UNIT CDISC submission value update. PT: g/m3 PT: mg/L 2011-12 P7-P8 III C67327 Submission Value SDTM-UNIT CDISC submission value update. PT: ug/m3 PT: ng/L 2011-12 P7-P8 II C67335 Submission Value SDTM-UNIT CDISC submission value update. PT: million IU PT: 10^6 IU 2011-12 P7-P8 III C68858 Submission Value SDTM-UNIT CDISC submission value update. PT: m3 PT: scm 2011-12 P7-P8 II C68895 Submission Value SDTM-UNIT CDISC submission value update. PT: thousand CFU PT: 10^3 CFU 2011-12 P7-P8 II C68896 Submission Value SDTM-UNIT CDISC submission value update. PT: million CFU PT: 10^6 CFU 2011-12 P7-P8 II C68897 Submission Value SDTM-UNIT CDISC submission value update. PT: billion CFU PT: 10^9 CFU 2011-12 P7-P8 II C68899 Submission Value SDTM-UNIT CDISC submission value update. PT: thousand CFU/g PT: 10^ 3 CFU/g 2011-12 P7-P8 II C68900 Submission Value SDTM-UNIT CDISC submission value update. PT: million CFU/g PT: 10^6 CFU/g 2011-12 P7-P8 II C68901 Submission Value SDTM-UNIT CDISC submission value update. PT: billion CFU/g PT: 10^9 CFU/g 2011-12 P7-P8 II C68903 Submission Value SDTM-UNIT CDISC submission value update. PT: thousand CFU/mL PT: 10^3 CFU/mL 2011-12 P7-P8 II C68904 Submission Value SDTM-UNIT CDISC submission value update. PT: million CFU/mL PT: 10^6 CFU/mL 2011-12 P7-P8 II C68905 Submission Value SDTM-UNIT CDISC submission value update. PT: billion CFU/mL PT: 10^9 CFU/mL 2011-12 P7-P8 III C71187 Submission Value SDTM-UNIT CDISC submission value update. PT: thousand Organisms PT: 10^3 Organisms 2011-12 P7-P8 III C71188 Submission Value SDTM-UNIT CDISC submission value update. PT: million Organisms PT: 10^6 organisms 2011-12 P7-P8 III C71189 Submission Value SDTM-UNIT CDISC submission value update. PT: billion Organisms PT: 10^9 organisms 2011-12 P7-P8 III C71190 Submission Value SDTM-UNIT CDISC submission value update. PT: thousand organisms/g PT: 10^3 organisms/g 2011-12 P7-P8 III C71191 Submission Value SDTM-UNIT CDISC submission value update. PT: million organisms/g PT: 10^6 organisms/g 2011-12 P7-P8 III C71192 Submission Value SDTM-UNIT CDISC submission value update. PT: billion organisms/g PT: 10^9 organisms/g 2011-12 P7-P8 III C71193 Submission Value SDTM-UNIT CDISC submission value update. PT: million organisms/mg PT: 10^6 organisms/mg 2011-12 P7-P8 III C71194 Submission Value SDTM-UNIT CDISC submission value update. PT: billion organisms/mg PT: 10^9 organisms/mg 2011-12 P7-P8 III C71195 Submission Value SDTM-UNIT CDISC submission value update. PT: thousand organisms/mL PT: 10^3 organisms/mL 2011-12 P7-P8 III C71196 Submission Value SDTM-UNIT CDISC submission value update. PT: million organisms/mL PT: 10^6 organisms/mL 2011-12 P7-P8 III C71197 Submission Value SDTM-UNIT CDISC submission value update. PT: billion organisms/mL PT: 10^9 organisms/mL 2011-12 P7-P8 II C67335 Definition SDTM-UNIT Definition update. Def: A unit of biological activity equal to one million international units.(NCI) Def: A unit of biological activity equal to 10 to the sixth power international units. 2011-12 P7-P8 II C68895 Definition SDTM-UNIT Definition update. Def: A unit of measurement of viable bacterial numbers equal to 10E3 colony forming units.(NCI) Def: A unit of measurement of viable bacterial numbers equal to 10 to the third power colony forming units. 2011-12 P7-P8 II C68896 Definition SDTM-UNIT Definition update. Def: A unit of measurement of viable bacterial numbers equal to 10E6 colony forming units.(NCI) Def: A unit of measurement of viable bacterial numbers equal to 10 to the sixth power colony forming units. 2011-12 P7-P8 II C68897 Definition SDTM-UNIT Definition update. Def: A unit of measurement of viable bacterial numbers equal to 10E9 colony forming units.(NCI) Def: A unit of measurement of viable bacterial numbers equal to 10 to the ninth power colony forming units. 2011-12 P7-P8 II C68899 Definition SDTM-UNIT Definition update. "Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of thousand colony forming units (10E3CFU) in one gram of substance.(NCI) " Definition: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of 10 to the third power colony forming units in one gram of substance. 2011-12 P7-P8 II C68900 Definition SDTM-UNIT Definition update. Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of million colony forming units (10E6CFU) in one gram of substance.(NCI) Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of 10 to the sixth power colony forming units in one gram of substance. 2011-12 P7-P8 II C68901 Definition SDTM-UNIT Definition update. Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of billion colony forming units (10E9CFU) in one gram of substance.(NCI) Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of 10 to the ninth power colony forming units in one gram of substance. 2011-12 P7-P8 II C68903 Definition SDTM-UNIT Definition update. Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of thousand colony forming units (10E3CFU) in one milliliter of substance.(NCI) Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of 10 to the third power colony forming units in one milliliter of substance. 2011-12 P7-P8 II C68904 Definition SDTM-UNIT Definition update. Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of million colony forming units (10E6CFU) in one milliliter of substance.(NCI) Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of 10 to the sixth power colony forming units in one milliliter of substance. 2011-12 P7-P8 II C68905 Definition SDTM-UNIT Definition update. Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of billion colony forming units (10E9CFU) in one milliliter of substance.(NCI) Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of 10 to the ninth power colony forming units in one milliliter of substance. 2011-12 P7-P8 II C71187 Definition SDTM-UNIT Definition update. Def: A unit of measure of quantity of organisms expressed in thousands.(NCI) Def: A unit of measure of quantity of organisms expressed in 10 to the third power of organisms. 2011-12 P7-P8 II C71188 Definition SDTM-UNIT Definition update. Def: A unit of measure of quantity of organisms expressed in millions.(NCI) Def: A unit of measure of quantity of organisms expressed in 10 to the sixth power of organisms. 2011-12 P7-P8 II C71189 Definition SDTM-UNIT Definition update. Def: A unit of measure of quantity of organisms expressed in billions.(NCI) Def: A unit of measure of quantity of organisms expressed in 10 to the ninth power of organisms. 2011-12 P7-P8 II C71190 Definition SDTM-UNIT Definition update. Def: A unit of measure of organism content expressed in thousands of organisms per unit of mass equal to one gram.(NCI) Def: A unit of measure of organism content expressed in 10 to the third power of organisms per unit of mass equal to one gram. 2011-12 P7-P8 II C71191 Definition SDTM-UNIT Definition update. Def: A unit of measure of organism content expressed in millions of organisms per unit of mass equal to one gram.(NCI) Def: A unit of measure of organism content expressed in 10 to the sixth power of organisms per unit of mass equal to one gram. 2011-12 P7-P8 II C71192 Definition SDTM-UNIT Definition update. Def: A unit of measure of organism content expressed in billions of organisms per unit of mass equal to one gram.(NCI) Def: A unit of measure of organism content expressed in 10 to the ninth power of organisms per unit of mass equal to one gram. 2011-12 P7-P8 II C71193 Definition SDTM-UNIT Definition update. Def: A unit of measure of organism content expressed in millions of organisms per unit of mass equal to one milligram.(NCI) Def: A unit of measure of organism content expressed in 10 to the sixth power of organisms per unit of mass equal to one milligram. 2011-12 P7-P8 II C71194 Definition SDTM-UNIT Definition update. Def: A unit of measure of organism content expressed in billions of organisms per unit of mass equal to one milligram.(NCI) Def: A unit of measure of organism content expressed in 10 to the ninth power of organisms per unit of mass equal to one milligram. 2011-12 P7-P8 II C71195 Definition SDTM-UNIT Definition update. Def: A unit of measure of organism concentration expressed in thousands of organisms per unit of volume equal to one milliliter.(NCI) Def: A unit of measure of organism concentration expressed in 10 to the third power of organisms per unit of volume equal to one milliliter. 2011-12 P7-P8 II C71196 Definition SDTM-UNIT Definition update. Def: A unit of measure of organism concentration expressed in millions of organisms per unit of volume equal to one milliliter.(NCI) Def: A unit of measure of organism concentration expressed in 10 to the sixth power of organisms per unit of volume equal to one milliliter. 2011-12 P7-P8 II C71197 Definition SDTM-UNIT Definition update. Def: A unit of measure of organism concentration expressed in billions of organisms per unit of volume equal to one milliliter.(NCI) Def: A unit of measure of organism concentration expressed in 10 to the ninth power of organisms per unit of volume equal to one milliliter. 2011-12 P7-P8 III MULTIPLE Submission Values SDTM-VSTEST; SDTM-VSTESTCD Addition of new terminology to existing codelist. See published spreadsheet 2011-07-22 Addition of 3 terms to an existing codelist. 2011-12 31428; 31429 II C84372 Synonym SDTM-VSTEST; SDTM-VSTESTCD Change the Synonym to "Knee to Heel Length" for VSTEST='Knee to Heel Length', or at least add "Knee to Heel Length" as the first synonym. SY: Lower Leg Length SY: Knee to Heel Length; Lower Leg Length 2011-12 N/A II C42554 Synonym SDTM-VSTRESU Capitalize Synonym SY: ohm SY: Ohm 2011-12 P7-P8 III C88025 Codelist SEND-NEOPLASM Addition of a new Neoplasm codelist for SDTM and SEND. - - - Addition of 303 terms to a new codelist. 2011-12 N/A I C78728 Synonym SDTM-RELTYPE Addition of synonym to term due to publication of term in the new PORTOT codelist.. - - - SY: Many; Several