Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New 6/28/2013 32368 II C89965 Codelist Extensibility SEND-DDTEST Death Diagnosis Test Name Change codelist extensibility. Yes No 6/28/2013 32368 II C89966 Codelist Extensibility SEND-DDTESTCD Death Diagnosis Test Code Change codelist extensibility. Yes No 6/28/2013 32297 III C106580 Term SEND-DSDECOD Standardized Disposition Term Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: UNPLANNED TERMINAL SACRIFICE 6/28/2013 N/A II C90436 Synonym SEND-DSDECOD Standardized Disposition Term Addition of a synonym. - - - PLANNED INTERIM SACRIFICE 6/28/2013 N/A II C90436 Submission Value SEND-DSDECOD Standardized Disposition Term Update to submission value for consistency. PLANNED INTERIM SACRIFICE INTERIM SACRIFICE 6/28/2013 N/A II C90436 Definition SEND-DSDECOD Standardized Disposition Term Update to definition for clarity. An indication that the study subject was sacrificed at a predetermined time before the end of the treatment period. An indication that the study subject was sacrificed at a predetermined time before the end of the planned treatment period. 6/28/2013 N/A II C90445 Synonym SEND-DSDECOD Standardized Disposition Term Addition of a synonym. - - - PLANNED RECOVERY SACRIFICE 6/28/2013 N/A II C90445 Definition SEND-DSDECOD Standardized Disposition Term Update to definition for clarity. An indication that the subject did not receive treatment for a specific period of time following the end of the treatment period before it was sacrificed. An indication that the subject did not receive treatment for a specific period of time following the end of the planned treatment period before it was sacrificed. 6/28/2013 N/A II C90465 Synonym SEND-DSDECOD Standardized Disposition Term Addition of a synonym. - - - PLANNED TERMINAL SACRIFICE 6/28/2013 N/A II C90465 Definition SEND-DSDECOD Standardized Disposition Term Update to definition for clarity. An indication that the subject was sacrificed at the end of the treatment period. An indication that the subject was sacrificed at the end of the planned treatment period. 6/28/2013 32424 III C106500 Term SEND-MTHTRM Method of Termination Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: ANESTHETIZED EXSANGUINATION AND PERFUSION 6/28/2013 32424 III C106506 Term SEND-MTHTRM Method of Termination Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: CAPTIVE BOLT EXSANGUINATION 6/28/2013 32424 III C106507 Term SEND-MTHTRM Method of Termination Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: CARBON DIOXIDE EXSANGUINATION 6/28/2013 N/A II C89975 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. Terminology related to the method by which an experimental organism is sacrificed. Terminology related to the method by which an experimental organism is euthanized. This includes events that occur as a step in the induction of death. 6/28/2013 N/A II C90355 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. A method of sacrifice whereby a subject is anesthetized and the spinal column is dislocated from the skull and brain. A method of euthanasia whereby a subject is anesthetized and the spinal column is dislocated from the skull and brain. 6/28/2013 N/A II C90356 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. A method of sacrifice whereby a subject is anesthetized and the head is removed from the body. A method of euthanasia whereby a subject is anesthetized and the head is removed from the body. 6/28/2013 N/A II C90357 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. A method of sacrifice whereby a subject is anesthetized and the body is drained of blood. A method of euthanasia whereby a subject is anesthetized and the body is drained of blood. 6/28/2013 N/A II C90358 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. A method of sacrifice whereby a subject is anesthetized and potassium chloride is administered intravenously to induce cardiac arrest. A method of euthanasia whereby a subject is anesthetized and potassium chloride is administered intravenously to induce cardiac arrest. 6/28/2013 N/A II C90369 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. A method of sacrifice whereby a subject inhales carbon dioxide until death occurs. A method of euthanasia whereby a subject inhales carbon dioxide until death occurs. 6/28/2013 N/A II C90371 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. A method of sacrifice whereby the spinal column is dislocated from the skull and brain. A method of euthanasia whereby the spinal column is dislocated from the skull and brain. 6/28/2013 N/A II C90375 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. A method of sacrifice whereby a subject's head is removed from the body. A method of euthanasia whereby a subject's head is removed from the body. 6/28/2013 N/A II C90400 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. A method of sacrifice whereby a subject is anesthetized and barbiturate(s) are administered intraperitoneally to induce respiratory arrest. A method of euthanasia whereby a subject is anesthetized and barbiturate(s) are administered intraperitoneally to induce respiratory arrest. 6/28/2013 N/A II C90401 Definition SEND-MTHTRM Method of Termination Update to definition. Correct nomenclature. A method of sacrifice whereby a subject is anesthetized and barbiturate(s) are administered intravenously to induce respiratory arrest. A method of euthanasia whereby a subject is anesthetized and barbiturate(s) are administered intravenously to induce respiratory arrest. 6/28/2013 32373 II C12458 Definition SEND-SPEC Specimen Update to definition for consistency across CDISC terminology standards An important supervisory center in the brain, rich in ganglia, nerve fibers, and synaptic connections. It is composed of several sections called nuclei, each of which controls a specific function. The hypothalamus regulates body temperature, blood pressure, heartbeat, metabolism of fats and carbohydrates, and sugar levels in the blood. Through direct attachment to the pituitary gland, the hypothalamus also meters secretions controlling water balance and milk production in the female. The role of the hypothalamus in awareness of pleasure and pain is well established in the laboratory. It is involved in the expression of emotions, such as fear and rage, and in sexual behaviors. The supervisory center in the brain, rich in ganglia, nerve fibers, and synaptic connections. It is composed of several sections called nuclei, each of which controls a specific function. 6/28/2013 32361 II C12499 Definition SEND-SPEC Specimen Update to definition for consistency across CDISC terminology standards The portion of the ear located within the temporal bone that is involved in both hearing and balance and includes the semicircular canals, vestibule, and cochlea. (from American Heritage Dictionary online) (NCI) The portion of the ear located within the temporal bone that is involved in both hearing and balance and includes the semicircular canals, vestibule, and cochlea. (from American Heritage Dictionary online) 6/28/2013 32360 II C12510 Definition SEND-SPEC Specimen Update to definition for consistency across CDISC terminology standards The uppermost portion of the brainstem located between the pons and the diencephalon. The midbrain contains the cerebral peduncles, oculomotor, trochlear and red nuclei, substantia nigra and various other nuclei and tracts. The uppermost portion of the brainstem located between the pons and the diencephalon. The midbrain contains the cerebral peduncles, oculomotor, trochlear and red nuclei, substantia nigra and various other nuclei and tracts. (NCI) 6/28/2013 32470 III C13236 Term SEND-SPEC Specimen Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: FLUID 6/28/2013 N/A II C32043 Synonym SEND-SPEC Specimen Addition of a synonym. - - - Calcaneal Tendon 6/28/2013 32469 II C77613 Synonym SEND-SPEC Specimen Addition of a synonym. - - - Pleural Fluid 6/28/2013 32466 III C14265 Term SEND-SPECIES Species Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: FROG 6/28/2013 32463 III C106538 Term SEND-STRAIN Strain/Substrain Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: LEWIS 6/28/2013 32462 III C106549 Term SEND-STRAIN Strain/Substrain Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: NIH MINIPIG 6/28/2013 32464 III C106572 Term SEND-STRAIN Strain/Substrain Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: SUFFOLK 6/28/2013 32464 III C106573 Term SEND-STRAIN Strain/Substrain Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: SWISS WEBSTER 6/28/2013 32491 II C98711 Synonym SEND-STRAIN Strain/Substrain Addition of a synonym. - - - CByB6F1-Tg(HRAS)2Jic 6/28/2013 32705 II C101224 Synonym SDTM-COUNTRY Country Up-case CDISC synonyms. Bonaire, Sint Eustatius and Saba BONAIRE, SINT EUSTATIUS AND SABA 6/28/2013 32705 II C101225 Synonym SDTM-COUNTRY Country Up-case CDISC synonyms. Curacao CURACAO 6/28/2013 32705 II C97351 Synonym SDTM-COUNTRY Country Up-case CDISC synonyms. South Sudan SOUTH SUDAN 6/28/2013 32448 III C102637 Term SDTM-DOMAIN Domain Abbreviation Retire CDISC controlled term. FF - - - 6/28/2013 32451 III C102722 NCI C-code SDTM-DOMAIN Domain Abbreviation NCI C-code change due to incorrect coding. C102722 C107097 6/28/2013 31963; 32529 II C102722/C107097 Definition SDTM-DOMAIN Domain Abbreviation Update to Definition. A domain for tumor response evaluations determined from the data in the tumor results domain. The RS domain represents disease response evaluations determined from collected data in the TR domain and/or other SDTM domains. 6/28/2013 32451 II C102722/C107097 NCI Preferred Term SDTM-DOMAIN Domain Abbreviation Update to NCI Preferred Term. Tumor Response Domain Disease Response Domain 6/28/2013 32451 II C102722/C107097 Synonym SDTM-DOMAIN Domain Abbreviation Change to synonym. Tumor Response Disease Response 6/28/2013 32215 III C106522 Term SDTM-DOMAIN Domain Abbreviation Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: FM 6/28/2013 32240; 32522 III C106552 Term SDTM-DOMAIN Domain Abbreviation Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: PB 6/28/2013 32240; 32522 III C106571 Term SDTM-DOMAIN Domain Abbreviation Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: SB 6/28/2013 N/A III C106577 Term SDTM-DOMAIN Domain Abbreviation Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: TU 6/28/2013 N/A III C106578 Term SDTM-DOMAIN Domain Abbreviation Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: TR 6/28/2013 32522 III C106581 Term SDTM-DOMAIN Domain Abbreviation Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: VR 6/28/2013 32270 II C49609 Definition SDTM-DOMAIN Domain Abbreviation Update to Definition. Questionnaire data may include, but are not limited to the following: subject reported outcomes, validated or non-validated questionnaires, and validated or non-validated diaries (i.e. data with a common topicality). Questionnaires are named, stand-alone instruments designed to provide an assessment of a concept. Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis. Most often, questionnaires have as their primary purpose the generation of a quantitative statistic to assess a qualitative concept. 6/28/2013 N/A II C100076 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of an atrial rhythm which originates from the sinoatrial node. An electrocardiographic finding of an atrial rhythm which originates from the sinoatrial node that is considered normal for the population. 6/28/2013 N/A II C101589 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury without specifying the anatomic region of the heart. An electrocardiographic finding of pathologic Q waves, which is suggestive of myocardial infarction of one or more regions of the heart. No specification is provided for localization. 6/28/2013 N/A II C101589 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Myocardial Infarction by Electrocardiographic Finding Myocardial Infarction by ECG Finding 6/28/2013 N/A II C101596 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing a current of injury without specifying the anatomic region of the heart. An electrocardiographic finding showing a current of injury with ST elevation. No specification is provided for localization. 6/28/2013 N/A II C101596 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Acute Myocardial Infarction by EKG Finding Acute Myocardial Infarction by ECG Finding 6/28/2013 N/A II C101597 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. OLD OR AGE INDETERMINATE WALL MYOCARDIAL INFARCTION OLD OR AGE INDETERMINATE MYOCARDIAL INFARCTION 6/28/2013 N/A II C101597 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury of indeterminate age in leads corresponding to the anatomic region of the wall of the heart. An electrocardiographic finding of pathologic Q waves, which is suggestive of myocardial infarction of one or more regions of the heart, without evidence of current or ongoing acute infarction. No specification is provided for localization. 6/28/2013 N/A II C101597 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Old Myocardial Infarction by EKG Finding Old Myocardial Infarction by ECG Finding 6/28/2013 N/A II C102591 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the anterolateral wall of the heart. An electrocardiographic finding of pathologic Q waves with accompanying ST elevation in leads V3 through V6, which is suggestive of acute myocardial infarction of the anterolateral wall of the left ventricle 6/28/2013 N/A II C102592 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the anteroseptal wall of the heart. An electrocardiographic finding of pathologic Q waves with accompanying ST elevation in leads V1 through V4, which is suggestive of acute myocardial infarction of the anteroseptal wall of the left ventricle. 6/28/2013 N/A II C102592 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Acute Anteroseptal Wall Myocardial Infarction Acute Anteroseptal Wall Myocardial Infarction; Acute anteroseptal MI 6/28/2013 N/A II C102593 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the high lateral wall of the heart. An electrocardiographic finding of pathologic Q waves with accompanying ST elevation in leads I and aVL, which is suggestive of acute myocardial infarction of the high lateral wall of the left ventricle. 6/28/2013 N/A II C102594 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the right ventricular wall of the heart. An electrocardiographic finding in leads V1 or V2 of an initial R wave duration greater than or equal to 40 ms, R wave greater than S wave, upright T wave, with accompanying ST elevation, which is suggestive of acute myocardial infarction of the ventricular wall of the left ventricle. Evidence of inferior or lateral myocardial infarction is usually also present. 6/28/2013 N/A II C102594 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Acute Right Ventricular Wall Myocardial Infarction Acute Right Ventricular Wall Myocardial Infarction; Acute Right ventricular MI 6/28/2013 N/A II C102595 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the septal wall of the heart. An electrocardiographic finding of pathologic Q waves with accompanying ST elevation in leads V1, V2 and often V3, which is suggestive of acute myocardial infarction of the intraventricular septum. 6/28/2013 N/A II C102596 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of a sinus beat followed by a premature atrial contraction for three or more consecutive cycles; a regularly irregular rhythm of normal and abnormal P waves in a 1-1 ratio. An electrocardiographic finding of a sinus beat followed by a premature atrial complexes for three or more consecutive cycles; a regularly irregular rhythm of normal and abnormal P waves in a 1-1 ratio. 6/28/2013 N/A II C102597 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which two premature atrial contractions occur in a row. An electrocardiographic finding in which two premature atrial complexes occur sequentially. 6/28/2013 N/A II C102598 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of two sinus beats followed by a premature atrial contraction for 3 or more consecutive cycles; a regularly irregular rhythm of normal and abnormal P waves in a 2-1 ratio. An electrocardiographic finding of two sinus beats followed by a premature atrial complex for 3 or more consecutive cycles; a regularly irregular rhythm of normal and abnormal P waves in a 2-1 ratio. 6/28/2013 N/A II C102603 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Premature Atrial Complexes Blocked Premature Atrial Complexes Blocked; Premature Atrial Complexes Non-conducted; Non-conducted SVE; Atrial premature complexes, nonconducted 6/28/2013 N/A II C102604 NCI C-code SDTM-EGSTRESC ECG Result NCI C-code change due to incorrect coding. C102604 C107100 6/28/2013 N/A II C102604 / C107100 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. PREMATURE VENTRICULAR COMPLEXES INTERPOLATED PREMATURE VENTRICULAR COMPLEX INTERPOLATED 6/28/2013 N/A II C102604 / C107100 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Blocked Ventricular Premature Complex Interpolated Ventricular Premature Complex 6/28/2013 N/A II C102604 / C107100 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Premature Ventricular Complexes Interpolated Premature Ventricular Complex Interpolated; Interpolated Ventricular Extra Beat; Interpolated VE; Interpolated VPC 6/28/2013 N/A II C102628 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Early R Wave Transition Early R Wave Transition; Early R Wave Progression 6/28/2013 N/A II C102629 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of J point and ST segment elevation in the absence of other signs of acute ischemia that is often a normal variant. An electrocardiographic finding of J point and ST segment elevation in the absence of other signs of acute ischemia or pericarditis. 6/28/2013 N/A II C102634 Definition SDTM-EGSTRESC ECG Result Update to Definition. Q axis from -90 to +180 degrees. An electrocardiographic finding of a frontal plane QRS axis from -90 to +180 degrees. 6/28/2013 N/A II C102634 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Northwest Axis Northwest Axis; Right superior axis 6/28/2013 N/A II C102639 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Fusion Complex Fusion Complex; Fusion complex(es) 6/28/2013 N/A II C102642 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles, characterized by two or more consecutive non-conducted P waves. An electrocardiographic finding of intermittent failure of atrial electrical impulse conduction to the ventricles, characterized by two or more consecutive non-conducted P waves. 6/28/2013 N/A II C102643 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the high lateral wall of the heart. An electrocardiographic finding of pathologic Q waves in leads I and aVL, which is suggestive of myocardial infarction of the high lateral wall of the left ventricle. 6/28/2013 N/A II C102652 Definition SDTM-EGSTRESC ECG Result Update to Definition. An ectopic impulse originating in the AV junction presenting as a QRS complex of supraventricular origin which is not preceded by a P wave. An electrocardiographic finding of an ectopic impulse originating in the AV junction presenting as a QRS complex of supraventricular origin which is not preceded by a P wave. 6/28/2013 N/A II C102652 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Junctional Premature Complex Junctional Premature Complex; Junctional Extra Beat; Junctional premature complex(es) 6/28/2013 N/A II C102653 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding where the amplitude of the R wave does not become greater than the amplitude of the S wave until an unusually late point in the precordial leads, usually in leads V4 or V5. An electrocardiographic finding where the amplitude of the R wave does not become greater than the amplitude of the S wave until an unusually late point in the precordial leads, usually in leads V4 to V6. 6/28/2013 N/A II C102672 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Premature Atrial Complexes Multifocal Premature Atrial Complexes Multifocal; Multifocal Supraventricular Extra Beats; Multifocal SVE 6/28/2013 N/A II C102673 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Premature Ventricular Complexes Multifocal Premature Ventricular Complexes Multifocal; Multifocal Ventricular Extra Beats; Multifocal VES; Multifocal VPCS 6/28/2013 N/A II C102675 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. MYOCARDIAL ISCHEMIA - - - 6/28/2013 N/A II C102680 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of an atrial rate greater than 100 beats per minute, P wave morphology which is not consistent with sinus rhythm, and which terminates in less than 30 seconds. An electrocardiographic finding of an atrial tachycardia which terminates in less than 30 seconds. 6/28/2013 N/A II C102681 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of an atrial rhythm which originates from the sinoatrial node that is considered normal for the population. An electrocardiographic finding of an atrial rhythm which originates from the sinoatrial node that is considered normal for the population. There are no extra beats or conduction abnormalities. 6/28/2013 N/A II C102684 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury of indeterminate age in leads corresponding to the anatomic region of the anterior wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V3 and V4, which is suggestive of myocardial infarction of the anterior wall of the left ventricle, without evidence of current or ongoing acute infarction. 6/28/2013 N/A II C102685 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury of indeterminate age in leads corresponding to the anatomic region of the anterolateral wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V3 through V6, which is suggestive of myocardial infarction of the anterolateral wall of the left ventricle, without evidence of current or ongoing acute infarction. 6/28/2013 N/A II C102686 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury of indeterminate age in leads corresponding to the anatomic region of the anteroseptal wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V1 through V4, which is suggestive of myocardial infarction of the anteroseptal wall of the left ventricle, without evidence of current or ongoing acute infarction. 6/28/2013 N/A II C102687 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing extensive injury of indeterminate age in leads corresponding to the anatomic region of the anterior wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V1 to V6, I and aVL, which is suggestive of myocardial infarction involving the anterior and anterolateral walls of the left ventricle, without evidence of current or ongoing acute infarction. 6/28/2013 N/A II C102688 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury of indeterminate age in leads corresponding to the anatomic region of the high lateral wall of the heart. An electrocardiographic finding of pathologic Q waves in leads I and aVL, which is suggestive of myocardial infarction of the high lateral wall of the left ventricle, without evidence of current or ongoing acute infarction. 6/28/2013 N/A II C102689 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury of indeterminate age in leads corresponding to the anatomic region of the inferior wall of the heart. An electrocardiographic finding of pathologic Q waves in leads III, aVF and often II, which is suggestive of myocardial infarction of the inferior wall of the left ventricle, without evidence of current or ongoing acute infarction. 6/28/2013 N/A II C102690 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury of indeterminate age in leads corresponding to the anatomic region of the lateral wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V5, V6, I and aVL , which is suggestive of myocardial infarction of the lateral wall of the left ventricle, without evidence of current or ongoing acute infarction. 6/28/2013 N/A II C102691 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury of indeterminate age in leads corresponding to the anatomic region of the posterior wall of the heart. An electrocardiographic finding in leads V1 or V2 of an initial R wave duration greater than or equal to 40 ms, R wave greater than S wave, and upright T wave, which is suggestive of myocardial infarction of the posterior wall of the left ventricle, without evidence of current or ongoing acute infarction. Evidence of inferior or lateral myocardial infarction is usually also present. 6/28/2013 N/A II C102692 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. OLD OR AGE INDETERMINATE RIGHT VENTRICULAR WALL MYOCARDIAL INFARCTION - - - 6/28/2013 N/A II C102693 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury of indeterminate age in leads corresponding to the anatomic region of the septal wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V1, V2 and often V3, which is suggestive of myocardial infarction of the intraventricular septum, without evidence of current or ongoing acute infarction. 6/28/2013 N/A II C102706 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Repolarization Abnormality Secondary To Ventricular Hypertrophy Repolarization Abnormality Secondary To Ventricular Hypertrophy; ST-T change due to ventricular hypertrophy 6/28/2013 N/A II C102709 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of a QT interval corrected for heart rate that is shorter than the lower limit of normal. An electrocardiographic finding of a QT interval corrected for heart rate that is shorter than the lower limit of normal. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C102725 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Premature Ventricular Complexes Unifocal Premature Ventricular Complexes Unifocal; Unifocal Ventricular Extra Beats; Unifocal VES; Unifocal VPCS 6/28/2013 N/A II C102728 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Ventricular Parasystole Ventricular Parasystole; Parasystole 6/28/2013 N/A II C102731 Definition SDTM-EGSTRESC ECG Result Update to Definition. A new electrocardiographic finding showing an injury in leads without specifying the anatomic region of the heart. An electrocardiographic finding of pathologic Q waves, which is suggestive of myocardial infarction of one or more regions of the heart and which is new compared to prior ECGs. No specification is provided for localization. 6/28/2013 N/A II C102732 Definition SDTM-EGSTRESC ECG Result Update to Definition. A new electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the anterior wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V3 and V4, which is suggestive of myocardial infarction of the anterior wall of the left ventricle and which is new compared to prior ECGs. 6/28/2013 N/A II C102732 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. New Anterior Wall Myocardial Infarction New Anterior Wall Myocardial Infarction; New Anterior MI 6/28/2013 N/A II C102733 Definition SDTM-EGSTRESC ECG Result Update to Definition. A new electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the anterolateral wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V3 through V6, which is suggestive of myocardial infarction of the anterolateral wall of the left ventricle and which is new compared to prior ECGs. 6/28/2013 N/A II C102734 Definition SDTM-EGSTRESC ECG Result Update to Definition. A new electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the anteroseptal wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V1 through V4, which is suggestive of myocardial infarction of the anteroseptal wall of the left ventricle and which is new compared to prior ECGs. 6/28/2013 N/A II C102735 Definition SDTM-EGSTRESC ECG Result Update to Definition. A new electrocardiographic finding showing extensive injury in leads corresponding to the anatomic region of the anterior wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V1 to V6, I and aVL, which is suggestive of myocardial infarction involving the anterior and anterolateral walls of the left ventricle and which is new compared to prior ECGs. 6/28/2013 N/A II C102736 Definition SDTM-EGSTRESC ECG Result Update to Definition. A new electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the high lateral wall of the heart. An electrocardiographic finding of pathologic Q waves in leads I and aVL, which is suggestive of myocardial infarction of the high lateral wall of the left ventricle and which is new compared to prior ECGs. 6/28/2013 N/A II C102737 Definition SDTM-EGSTRESC ECG Result Update to Definition. A new electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the inferior wall of the heart. An electrocardiographic finding of pathologic Q waves in leads III, aVF and often II, which is suggestive of myocardial infarction of the inferior wall of the left ventricle and which is new compared to prior ECGs. 6/28/2013 N/A II C102738 Definition SDTM-EGSTRESC ECG Result Update to Definition. A new electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the lateral wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V5, V6, I and aVL, which is suggestive of myocardial infarction of the lateral wall of the left ventricle and which is new compared to prior ECGs. 6/28/2013 N/A II C102739 Definition SDTM-EGSTRESC ECG Result Update to Definition. A new electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the septal wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V1, V2 and often V3, which is suggestive of myocardial infarction of the intraventricular septum and which is new compared to prior ECGs. 6/28/2013 N/A III C106496 Term SDTM-EGSTRESC ECG Result Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: ACUTE EXTENSIVE ANTERIOR WALL MYOCARDIAL INFARCTION 6/28/2013 N/A III C106502 Term SDTM-EGSTRESC ECG Result Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: BIVENTRICULAR HYPERTROPHY 6/28/2013 N/A III C106503 Term SDTM-EGSTRESC ECG Result Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: BRUGADA SYNDROME PATTERN 6/28/2013 N/A III C106520 Term SDTM-EGSTRESC ECG Result Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: EXTENSIVE ANTERIOR WALL MYOCARDIAL INFARCTION 6/28/2013 N/A III C106548 Term SDTM-EGSTRESC ECG Result Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: NEW POSTERIOR WALL MYOCARDIAL INFARCTION 6/28/2013 N/A III C106579 Term SDTM-EGSTRESC ECG Result Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: U WAVE ABNORMALITY 6/28/2013 N/A II C26889 Definition SDTM-EGSTRESC ECG Result Update to Definition. A heart rate of more than 100 beats per minute, with its origin in the sinus node. (NCI) An electrocardiographic finding of abnormally rapid heart rate with its origin in the sinus node. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C26923 Definition SDTM-EGSTRESC ECG Result Update to Definition. A heart rate of less than 60 beats per minute, with its origin in the sinus node. (NCI) An electrocardiographic finding of abnormally slow heart rate with its origin in the sinus node. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C34786 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. VENTRICULAR ARRHYTHMIA ASSOCIATED WITH LONG QT SYNDROME - - - 6/28/2013 N/A II C34940 Definition SDTM-EGSTRESC ECG Result Update to Definition. A condition characterized by the activation of the whole or some part of the ventricle by the transmission of an atrial impulse along an accessory pathway rather than by way of the normal specific conduction system which includes a delay at the atrioventricular node. (NCI) An electrocardiographic finding characterized by a premature activation of the whole or some part of the ventricle. The PR interval is usually shortened and delta waves are frequently present. 6/28/2013 N/A II C34940 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Pre-excitation Pre-excitation; Ventricular preexcitation 6/28/2013 N/A II C35058 Definition SDTM-EGSTRESC ECG Result Update to Definition. A supraventricular tachycardia due to reentry along a circuit contained within the AV node. AVNRT is the most common form of supraventricular tachycardia and usually presents as a narrow QRS complex tachycardia at a rate between 150 and 250 beats per minute. (NCI) An electrocardiographic finding of a regular supraventricular tachycardia due to reentry within the AV node. It is characterized by P waves which typically occurs nearly simultaneously with the QRS complex, resulting in a P wave which is obscured by the QRS, merged with the QRS or which may follow the QRS. 6/28/2013 N/A II C35059 Definition SDTM-EGSTRESC ECG Result Update to Definition. An automatic tachycardia originating in the atrioventricular junction, typically arising in the conduction tissues surrounding the atrioventricular node. A junctional tachycardia tends to be a regular, narrow complex tachycardia and usually occurs during myocardial infarction, after heart surgery, or in digitalis intoxication. The rate may range from 140 to 250 beats per minute. (NCI) An electrocardiographic finding of a junctional rhythm with a heart rate which is abnormally elevated. 6/28/2013 N/A II C35061 Definition SDTM-EGSTRESC ECG Result Update to Definition. A generic expression for any tachycardia that originates in the atria or the atrioventricular node. (NCI) An electrocardiographic finding of a tachycardia which does not originate in the ventricles or His Purkinje system. There is an abnormally high heart rate and QRS complexes are typically narrow, but aberration or preexcitation may be present. 6/28/2013 N/A II C35132 Definition SDTM-EGSTRESC ECG Result Update to Definition. A type of ventricular pre-excitation resulting from the activation of an accessory pathway known as the Bundle of Kent. This pathway presents an abnormal electrical communication from the atria to the ventricles. Wolff-Parkinson-White syndrome is characterized by a short PR interval and a long QRS interval with a delta wave. (NCI) An electrocardiographic finding of ventricular pre-excitation. The syndrome is characterized by a short PR interval and a long QRS interval with a delta wave. 6/28/2013 N/A II C35132 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Wolff-Parkinson-White syndrome Wolff-Parkinson-White syndrome; WPW 6/28/2013 N/A II C35303 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the anterolateral wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V3 through V6, which is suggestive of myocardial infarction of the anterolateral wall of the left ventricle. 6/28/2013 N/A II C35303 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Anterolateral Myocardial Infarction Anterolateral Myocardial Infarction by ECG Finding 6/28/2013 N/A II C35304 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the anteroseptal wall of the heart. An electrocardiographic finding of pathologic Q waves in leads V1 through V4, which is suggestive of myocardial infarction of the anteroseptal wall of the left ventricle. 6/28/2013 N/A II C35304 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Anteroseptal Myocardial Infarction Anteroseptal Myocardial Infarction by ECG Finding 6/28/2013 N/A II C35304 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Anteroseptal Wall Myocardial Infarction Anteroseptal Wall Myocardial Infarction; Anteroseptal MI 6/28/2013 N/A II C35398 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the inferior wall of the heart. (NCI) An electrocardiographic finding of pathologic Q waves in leads III, aVF and often II, which is suggestive of myocardial infarction of the inferior wall of the left ventricle. 6/28/2013 N/A II C35398 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Inferior Wall Myocardial Infarction Inferior Myocardial Infarction by ECG Finding 6/28/2013 N/A II C35398 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Inferior Wall Myocardial Infarction Inferior Wall Myocardial Infarction; Inferior MI 6/28/2013 N/A II C35481 Definition SDTM-EGSTRESC ECG Result Update to Definition. Any rapid heart rhythm originating in the atria. Atrial fibrillation and atrial flutter are varieties of atrial tachycardia. Atrial tachycardia is an electrical circuit originating in the upper or atrial chambers. This electrical circuit or focus takes over and generates rapid impulses across the atrial chambers. These impulses are transmitted to the ventricular chambers resulting in a rapid rate. These arrhythmias may originate from a variety of places across the atria. They may exist as an isolated problem or be related to an ongoing structural problem within the heart. (NCI) An electrocardiographic finding of an organized, regular atrial rhythm with atrial rate between 101 and 240 beats per minute. The P wave morphology must be distinct from the sinus P wave morphology. 6/28/2013 N/A II C35586 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the lateral wall of the heart. (NCI) An electrocardiographic finding of pathologic Q waves in leads V5, V6, I and aVL, which is suggestive of myocardial infarction of the lateral wall of the left ventricle. 6/28/2013 N/A II C35586 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Lateral Wall Myocardial Infarction Lateral Myocardial Infarction by ECG Finding 6/28/2013 N/A II C35586 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Lateral Wall Myocardial Infarction Lateral Wall Myocardial Infarction; Lateral MI 6/28/2013 N/A II C37920 Definition SDTM-EGSTRESC ECG Result Update to Definition. Non-sinus origin slow heart rate. An electrocardiographic finding of abnormally slow heart rate. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C38029 Definition SDTM-EGSTRESC ECG Result Update to Definition. An abnormally rapid heartbeat, usually applied to a heart rate above 100 per minute.. An electrocardiographic finding of abnormally rapid heart rate. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C41330 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. ST Depression ST Segment Depression 6/28/2013 N/A II C50466 Definition SDTM-EGSTRESC ECG Result Update to Definition. A supraventricular arrhythmia characterized by uncoordinated atrial myocardium activation due to multiple reentry circuits with consequent deterioration of atrial mechanical function. Instead of intermittently contracting, the atria quiver continuously in a chaotic pattern, causing a totally irregular, often tachycardia ventricular rate. On the ECG it is described by the replacement of consistent P waves by rapid oscillations or fibrillatory waves that vary in size, shape, and timing, associated with an irregular, frequently rapid ventricular response when atrioventricular conduction is intact. (NCI) An electrocardiographic finding of a supraventricular arrhythmia characterized by the replacement of consistent P waves by rapid oscillations or fibrillatory waves that vary in size, shape and timing and are accompanied by an irregularly irregular ventricular response. 6/28/2013 N/A II C50501 Definition SDTM-EGSTRESC ECG Result Update to Definition. Complete failure of atrial electrical impulse conduction through the AV node to the ventricles. (NCI) An electrocardiographic finding of complete failure of atrial electrical impulse conduction to the ventricles. This is manifest on the ECG by disassociation of atrial and ventricular rhythms. The atrial rate must be faster than the ventricular rate. 6/28/2013 N/A II C50501 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. 3rd degree AV block 3rd degree AV block; Complete Heart Block; AV block, complete (third-degree) 6/28/2013 N/A II C50540 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. ST Elevation ST Segment Elevation 6/28/2013 N/A II C50553 Definition SDTM-EGSTRESC ECG Result Update to Definition. A blockage of electrical conduction within the sinoatrial node resulting in the failure of impulse transmission from the sinoatrial node. (NCI) An electrocardiographic finding in which impaired conduction or automaticity within the sinus node results in the failure of impulse transmission from the sinoatrial node. This is manifest as dropped P waves during sinus rhythm. 6/28/2013 N/A II C50553 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Sinoatrial Node Exit Block Exit Block 6/28/2013 N/A II C50553 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Sinoatrial exit block Sinoatrial exit block; Sinoatrial Block; SA Block 6/28/2013 N/A II C50599 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of an ectopic ventricular rhythm with three or more consecutive ventricular premature beats with a rate less than 100 beats per minute. An electrocardiographic finding of three or more consecutive complexes of ventricular origin with a rate less than a certain threshold (100 or 120 beats per minute are commonly used). The QRS complexes are wide and have an abnormal morphology. 6/28/2013 N/A II C50779 Definition SDTM-EGSTRESC ECG Result Update to Definition. An atypical rapid polymorphic ventricular tachycardia with a characteristic rotation of the QRS complex around the isoelectric baseline. In addition the QRS complex displays a periodic waxing and waning of amplitude on the electrogram. (NCI) An electrocardiographic finding of an atypical rapid polymorphic ventricular tachycardia with a characteristic rotation of the QRS complex around the isoelectric baseline, occurring in the setting of a prolonged QT interval. In addition, the QRS complex displays a periodic waxing and waning of amplitude on the electrogram. 6/28/2013 N/A II C50779 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Torsades de pointes Torsades de pointes; Ventricular tachycardia, torsades de pointes 6/28/2013 N/A II C50799 Definition SDTM-EGSTRESC ECG Result Update to Definition. Ventricular Fibrillation is characterized by rapid, usually more than 300 bpm (cycle length: 180 ms or less), grossly irregular ventricular rhythm with marked variability in QRS cycle length, morphology, and amplitude. An electrocardiographic finding of a rapid grossly irregular ventricular rhythm with marked variability in QRS cycle length, morphology, and amplitude. The rate is typically greater than 300 bpm. 6/28/2013 N/A II C50802 Definition SDTM-EGSTRESC ECG Result Update to Definition. A tachycardia arising distal to bundle of His, with a rate greater than 100 beats per minute. (NCI) An electrocardiographic finding of three or more consecutive complexes of ventricular organ with a rate greater than a certain threshold (100 or 120 beats per minute are commonly used). The QRS complexes are wide and have an abnormal morphology. 6/28/2013 N/A II C51224 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of an organized rhythmic contraction of the atria which is generally at a rate of 200-300 beats per minute. (NCI) An electrocardiographic finding of an organized, regular atrial rhythm with atrial rate of 240-340 beats per minute. Multiple P waves typically appear in the inferior leads in a saw tooth like pattern between the QRS complexes. 6/28/2013 N/A II C61395 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic phenomena in which the R wave occurs on top of the T wave; this can trigger ventricular fibrillation or ventricular tachycardia. (NCI) An electrocardiographic finding in which the R wave of a premature ventricular complex occurs on top of the T wave of the preceding beat. 6/28/2013 N/A II C62015 Definition SDTM-EGSTRESC ECG Result Update to Definition. A delay in the time required for the conduction of an electrical impulse through the atrioventricular (AV) node beyond 0.2 seconds; prolongation of the PR interval beyond 200 milliseconds. (NCI) An electrocardiographic finding of prolonged PR interval for a specific population. For adults one common threshold is a PR interval greater than 0.20 seconds. Note that other thresholds may be applicable. 6/28/2013 N/A II C62015 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. 1st degree AV block 1st degree AV block; PR Prolongation; Prolonged PR interval 6/28/2013 N/A II C62016 Definition SDTM-EGSTRESC ECG Result Update to Definition. Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles. (NCI) An electrocardiographic finding of intermittent failure of atrial electrical impulse conduction to the ventricles. This is manifest on the ECG by regular P waves which intermittently are not followed by QRS complexes. 6/28/2013 N/A II C62017 Definition SDTM-EGSTRESC ECG Result Update to Definition. Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles, characterized by a progressively lengthening PR interval prior to the block of an atrial impulse. An electrocardiographic finding of intermittent failure of atrial electrical impulse conduction to the ventricles, characterized by a progressively lengthening PR interval prior to the block of an atrial impulse. 6/28/2013 N/A II C62017 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. AV Mobitz I AV Block Second Degree Mobitz Type I 6/28/2013 N/A II C62017 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. AV Mobitz I AV Mobitz I; Wenckebach; Second degree AV block- Mobitz type I; Mobitz I Second Degree AV Block; Second-degree AV block, Mobitz type I (Wenckebach) 6/28/2013 N/A II C62018 Definition SDTM-EGSTRESC ECG Result Update to Definition. Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles, characterized by a relatively constant PR interval prior to the block of an atrial impulse. An electrocardiographic finding of intermittent failure of atrial electrical impulse conduction to the ventricles, characterized by a relatively constant PR interval prior to the block of an atrial impulse. 6/28/2013 N/A II C62018 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. AV Mobitz II AV Block Second Degree Mobitz Type II 6/28/2013 N/A II C62018 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. AV Mobitz II AV Mobitz II; Second degree AV block- Mobitz type II; Mobitz II Second Degree AV Block; Second-degree AV block, Mobitz type II 6/28/2013 N/A II C62234 Definition SDTM-EGSTRESC ECG Result Update to Definition. A ventricular tachycardia in which the ventricular activation sequence is constant. The morphology of the electrocardiographic waveform is unchanging and is referred to as monomorphic. (NCI) An electrocardiographic finding of a ventricular tachycardia in which the QRS complexes have a uniform morphology. 6/28/2013 N/A II C62236 Definition SDTM-EGSTRESC ECG Result Update to Definition. A ventricular tachycardia in which the ventricular activation sequence is variable. The morphology of the electrocardiographic waveform is variable and is referred to as polymorphic. (NCI) An electrocardiographic finding of a ventricular tachycardia in which the QRS complexes have a variable morphology and often rate. 6/28/2013 N/A II C62236 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Ventricular tachycardia, polymorphic Ventricular tachycardia, polymorphic; Ventricular tachycardia, polymorphous 6/28/2013 N/A II C62239 Definition SDTM-EGSTRESC ECG Result Update to Definition. Irregularity of the heartbeat due to a variation in the sinus rhythm resulting in cyclic changes in the heart rate during breathing. This rhythm is most commonly seen with breathing due to fluctuations in parasympathetic vagal tone. During inspiration stretch receptors in the lungs stimulate the cardioinhibitory centers in the medulla via fibers in the vagus nerve. Irregularity of the heartbeat due to a variation in the sinus rhythm resulting in cyclic changes in the heart rate during breathing. This rhythm is most commonly seen with breathing due to fluctuations in parasympathetic vagal tone. During inspiration stretch receptors in the lungs stimulate the cardioinhibitory centers in the medulla via fibers in the vagus nerve. (NCI) An electrocardiographic finding in which the sinus rate fluctuates with the respiratory cycle. 6/28/2013 N/A II C62239 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Sinus arrhythmia Sinus arrhythmia; Respiratory Sinus Arrhythmia 6/28/2013 N/A II C62240 Definition SDTM-EGSTRESC ECG Result Update to Definition. A condition characterized by the site of origin of impulses, controlling the heart rate, changing within the atria, including the sinus node. Variations within P waves and PR intervals occur and an irregular rate of impulse formation is observed. (NCI) An electrocardiographic finding of a supraventricular arrhythmia characterized by 3 or more distinct P wave morphologies with an isoelectric baseline, variable PR intervals and no predominant atrial rhythm. The ventricular rate is typically below 100 beats per minute. 6/28/2013 N/A II C62242 Definition SDTM-EGSTRESC ECG Result Update to Definition. A failure of impulse formation in the sinus node. Sinus arrest is indistinguishable from third degree sinoatrial exit block on the standard ECG. (NCI) An electrocardiographic finding in which a failure of impulse formation or conduction in the sinus node produces prolongation of the P-P interval or dropped P waves. The threshold for the prolongation of the P-P interval is not well defined. 6/28/2013 N/A II C62242 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Sinus arrest/pause Sinus arrest/pause; Sinus pause or arrest 6/28/2013 N/A II C62243 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. SINUS NODE DYSFUNCTION (BRADYCARDIA) - - - 6/28/2013 N/A II C62244 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. SICK SINUS SYNDROME - - - 6/28/2013 N/A II C62245 Definition SDTM-EGSTRESC ECG Result Update to Definition. A cardiac rhythm resulting from either an abnormal electrical focus in the atria or intra-atrial reentry. Atrial ectopic beats (AEB) refer to a contraction of the upper heart chamber which occurs before it would be expected. Atrial ectopic beats are also known as premature atrial beats, premature atrial complex (PAC), or atrial extrasystole. (NCI) An electrocardiographic finding of a regular atrial rhythm with atrial rate of less than 101 beats per minute which does not originate in the sinus node, and which is characterized by P waves whose morphology differs from the P wave morphology during sinus rhythm. 6/28/2013 N/A II C62246 Definition SDTM-EGSTRESC ECG Result Update to Definition. A PR interval of less than 0.12 seconds. (NCI) An electrocardiographic finding of an abnormally short PR interval. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C62247 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. PR PROLONGATION - - - 6/28/2013 N/A II C62248 Definition SDTM-EGSTRESC ECG Result Update to Definition. Atrioventricular dissociation characterized by atria and ventricles beating at similar rates, although independently. An electrocardiographic finding of a type of atrioventricular dissociation characterized by the atria (P waves) and ventricles (QRS complexes) beating at similar rates, although independently. 6/28/2013 N/A II C62250 Definition SDTM-EGSTRESC ECG Result Update to Definition. Sudden onset AV block, often associated with preexisting conduction disorders. (NCI) An electrocardiographic finding of the sudden onset of transient AV block, which is often associated with preexisting conduction disorders. 6/28/2013 N/A II C62253 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. INAPPROPRIATE SINUS TACHYCARDIA - - - 6/28/2013 N/A II C62256 Definition SDTM-EGSTRESC ECG Result Update to Definition. Ectopic impulses originating in the ventricles. (NCI) An electrocardiographic finding of an ectopic impulse originating in the ventricles. The QRS morphology of these complexes is different from those of supraventricular origin. The QRS duration is often longer and the RR interval preceding the complexes is usually shorter than that of supraventricular beats. 6/28/2013 N/A II C62256 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. PVC PVC; Ventricular Extra Beat; VE; VPC; Ventricular premature complex(es) 6/28/2013 N/A II C62257 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. PREMATURE ATRIAL COMPLEXES PREMATURE ATRIAL COMPLEX 6/28/2013 N/A II C62257 Definition SDTM-EGSTRESC ECG Result Update to Definition. Ectopic impulses originating in the atria. (NCI) An electrocardiographic finding of an ectopic impulse originating in the atria and not specifically in the sinus node. The P wave morphology of these complexes is often different from a sinus P wave and the RR intervals preceding these complexes is also shorter than those of the regular beats. 6/28/2013 N/A II C62257 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Premature atrial complexes Premature atrial complex; Supraventricular Extra Beat; SVE; APC; PAC; Atrial premature complex(es) 6/28/2013 N/A II C62258 Definition SDTM-EGSTRESC ECG Result Update to Definition. An initial slurring (delta wave) of the QRS complex due to the presence of an accessory pathway. This characteristic EKG pattern is typically seen in Wolff-Parkinson-White syndrome. An electrocardiographic finding of initial slurring (delta wave) of the QRS complex due to the presence of an accessory pathway. This characteristic ECG pattern is typically seen in Wolff-Parkinson-White syndrome. 6/28/2013 N/A II C62258 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. EKG Delta Wave Delta Wave 6/28/2013 N/A II C62259 Definition SDTM-EGSTRESC ECG Result Update to Definition. Two sequential ventricular premature complexes. An otherwise normal finding, but possibly indicative of electrical heart disease particularly in comparison with a single ventricular premature complexes. (NCI) An electrocardiographic finding in which two premature ventricular complexes occur sequentially. 6/28/2013 N/A II C62259 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Ventricular couplet Ventricular couplet; Ventricular Pair 6/28/2013 N/A II C62261 Definition SDTM-EGSTRESC ECG Result Update to Definition. A supraventricular tachycardia due to reentry along a circuit including a concealed AV nodal bypass tract. This tachycardia circuit proceeds in an antegrade fashion through the AV node and then is conducted retrograde through the bypass tract into the atria. (NCI) An electrocardiographic finding of a regular supraventricular tachycardia which utilizes an atrioventricular bypass tract as its retrograde limb (orthodromic tachycardia) or as its antegrade limb (antidromic tachycardia). QRS complexes during sinus rhythm may show preexcitation. During orthodromic tachycardia the preexcitation is not present and a retrograde P wave may appear after the QRS complex. During antidromic tachycardia the QRS complex is preexcited. 6/28/2013 N/A II C62266 Definition SDTM-EGSTRESC ECG Result Update to Definition. The term accelerated idioventricular rhythm describes an ectopic ventricular rhythm with 3 or more consecutive ventricular premature beats with a rate faster than the normal ventricular intrinsic escape rate of 30 to 40 beats per minute, but slower than ventricular tachycardia. Accelerated idioventricular rhythm differs from ventricular tachycardia by additional features such as the onset with a long coupling interval and the end by a gradual decrease of the ventricular rate or increase of the sinus rate. (NCI) An electrocardiographic finding of idioventricular rhythm with a rate greater than 50 beats per minute. 6/28/2013 N/A II C62267 Definition SDTM-EGSTRESC ECG Result Update to Definition. An impairment of transmission of the cardiac electrical impulse along the fibers of the left anterior fascicle. In left anterior fascicular block (LAFB) the posteroinferior regions of the left ventricular endocardium are activated abnormally before the anterosuperior left ventricular area. After emerging from the posteroinferior division of the left bundle branch, the impulse first propagates in an inferior, rightward, and usually anterior direction for a short period of time. This orientation is responsible for the small Q waves in leads 1 and aVL and for the R waves in leads II, III, and aVF. (NCI) An electrocardiographic finding of a slightly widened QRS duration (typically less than 120 ms) with leftward frontal plane QRS axis and typically small Q waves in leads I and aVL. 6/28/2013 N/A II C62267 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Left anterior fascicular block Left anterior fascicular block; Left Anterior Hemiblock 6/28/2013 N/A II C62268 Definition SDTM-EGSTRESC ECG Result Update to Definition. An impairment of transmission of the cardiac electrical impulse along the fibers of the left posterior fascicle. In pure left posterior fascicular block (LPFB), the impulse emerges from the unblocked anterosuperior division, thus producing small q waves in leads II, III, and aVF. Thereafter, the impulse moves through the electrically predominant left ventricle in an inferior and rightward direction, thus explaining the S waves in leads I and aVL as well as the R waves in leads II, III, and aVF. (NCI) An electrocardiographic finding of an S1Q3 pattern and QRS axis greater than or equal to 120 degrees. It is usually seen in association with other abnormalities (e.g. RBBB or RVH). 6/28/2013 N/A II C62268 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Left posterior fascicular block Left posterior fascicular block; Left Posterior Hemiblock 6/28/2013 N/A II C62269 Definition SDTM-EGSTRESC ECG Result Update to Definition. An impairment of transmission of the cardiac electrical impulse along the fibers of the left main bundle branch, or both the left anterior fascicle and left posterior fascicle. This conduction disturbance is characterized by wide (greater than 0.11s) QRS complexes. The diagnostic criteria consist of prolongation of the QRS complexes (over 0.11s) with neither a Q wave nor an S wave in lead V1 and in the properly placed V6. A wide R wave with a notch on its top (plateau) is seen in these leads. In hearts with an electrical (and anatomic) vertical position a small Q wave may be seen in AVL in the absence of MI. Right chest lead V1 may or may not show an initial R wave, but the latter should be present in lead V2. (NCI) An electrocardiographic finding of a wide QRS complex with evidence of delayed conduction to the left ventricle, manifest as a widened initial portion of the QRS complex in leads V5, V6, I and aVL and with QRS duration greater than or equal to 120 ms. 6/28/2013 N/A II C62269 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Left bundle branch block Left bundle branch block; Complete LBBB; Left bundle-branch block 6/28/2013 N/A II C62270 Definition SDTM-EGSTRESC ECG Result Update to Definition. An impairment of transmission of the cardiac electrical impulse along the fibers of the right bundle branch. A "complete RBBB pattern" (with QRS duration > 0.11s) does not necessarily reflect the existence of a total conduction block in the right branch. This pattern only indicates that the entire or major parts of both ventricles are activated by the impulse emerging from the left branch. Thus, a significant degree of conduction delay ("high-grade" or "incomplete RBBB") can produce a similar pattern. (NCI) An electrocardiographic finding of a wide QRS complex with evidence of delayed conduction to the right ventricle, manifest by a widened initial portion of the QRS in V1 and V2, a widened S wave in V5, V6, I and aVL, and with QRS duration greater than or equal to 120 ms. An RsR' complex is typically present in leads V1 and V2. 6/28/2013 N/A II C62270 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Right Bundle Branch Block Right Bundle Branch Block; Complete RBBB; Right bundle-branch block 6/28/2013 N/A II C62271 Definition SDTM-EGSTRESC ECG Result Update to Definition. A delay in transmission of cardiac electrical impulses in the His-Purkinje system, diagnosed when the QRS is modestly prolonged (< 120 msec) and the QRS pattern and axis are not typical of a hemiblock. The conduction delay is considered to occur beyond the Purkinje's myocardial gates and arises from slow cell-to-cell conduction. The phenomenon is common in patients with acute MI. (NCI) An electrocardiographic finding of a widened QRS duration typically greater than 110 ms which does not meet the morphologic criteria for any of the standard bundle branch or fascicular block patterns. 6/28/2013 N/A II C62271 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Intraventricular conduction delay, nonspecific Intraventricular conduction delay, nonspecific; Intraventricular conduction delay 6/28/2013 32203 II C71026 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. ST SEGMENT ABNORMALITY - - - 6/28/2013 N/A II C71027 NCI C-code SDTM-EGSTRESC ECG Result NCI C-code change due to merge. C71027 C41330 6/28/2013 N/A II C71027 / C41330 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. ST Depression ST Segment Depression 6/28/2013 N/A II C71029 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of ST changes consistent with pericarditis. (NCI) An electrocardiographic finding of ST elevation which is concave upwards, and which is often accompanied by PR segment depression. 6/28/2013 N/A II C71030 Definition SDTM-EGSTRESC ECG Result Update to Definition. Elevation of the J point above the baseline; the J point represents the end of ventricular depolarization and located at the terminus of the QRS complex. (NCI) An electrocardiographic finding of a significant elevation above the baseline of the J point. 6/28/2013 N/A II C71032 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. NOTCHED T-WAVES NOTCHED T WAVES 6/28/2013 N/A II C71032 Definition SDTM-EGSTRESC ECG Result Update to Definition. Any depression occurring in a positive t wave. (NCI) An electrocardiographic finding of an irregular, u or v shaped deflection within the contour of the T wave. 6/28/2013 N/A II C71032 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Notched T-Waves T Wave Notched 6/28/2013 N/A II C71032 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Notched T-waves Notched T Waves 6/28/2013 N/A II C71033 Definition SDTM-EGSTRESC ECG Result Update to Definition. A lack of progression of R wave height across precordial leads. An electrocardiographic finding of a lack of progression of R wave height across precordial leads. 6/28/2013 N/A II C71034 Definition SDTM-EGSTRESC ECG Result Update to Definition. A QT interval that is prolonged. The length of the QT interval varies with the heart rate. (NCI) An electrocardiographic finding in which the QT interval not corrected for heart rate is prolonged. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C71034 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Prolonged QT Prolonged QT; Prolonged QT interval 6/28/2013 N/A II C71039 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding which comprises left, right or bilateral atrial enlargement. (NCI) An electrocardiographic finding which comprises left, right or bilateral atrial enlargement. This is may be characterized by prolonged P wave duration, increased P wave amplitude, or multi-component P waves. 6/28/2013 N/A II C71039 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. EKG Finding Atrial Enlargement Atrial Enlargement by ECG Finding 6/28/2013 N/A II C71040 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. LEFT ATRIAL ENLARGEMENT LEFT ATRIAL ABNORMALITY 6/28/2013 N/A II C71040 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. P-mitrale P-mitrale; Left Atrial Enlargement 6/28/2013 N/A II C71041 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. P-pulmonale P-pulmonale; Right Atrial Enlargement 6/28/2013 N/A II C71042 Definition SDTM-EGSTRESC ECG Result Update to Definition. A cardiac rhythm resulting from either an abnormal electrical focus in the ventricle. Ventricular ectopic beats (VEB) refer to a contraction of the lower heart chamber which occurs before it would be expected. Ventricular ectopic beats are also known as premature ventricular beats, premature ventricular complex (PVC), or ventricular extrasystole. (NCI) An electrocardiographic finding of three or more consecutive complexes of ventricular origin. The QRS complexes are wide and have an abnormal morphology. 6/28/2013 32202 II C71043 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. ECTOPIC SUPRAVENTRICULAR RHYTHM - - - 6/28/2013 N/A II C71044 Definition SDTM-EGSTRESC ECG Result Update to Definition. A electrocardiographic finding of an electrical phenomenon in which the ratio of electrical impulse generated above the atrioventricular node to the number of impulses conducted through to the ventricles is 2:1. (NCI) An electrocardiographic finding of a supraventricular rhythm where the ratio of impulses generated above the atrioventricular node to the number of impulses conducted through to the ventricles is 2:1. This is manifest on the ECG as 2 P waves per QRS complex. 6/28/2013 N/A II C71045 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the electrical activity of the atria and ventricles are causally independent of one another. (NCI) An electrocardiographic finding in which the electrical activity of the atria and ventricles are independent of one another. 6/28/2013 N/A II C71045 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Atrioventricular dissociation Atrioventricular dissociation; AV Dissociation 6/28/2013 N/A II C71047 Definition SDTM-EGSTRESC ECG Result Update to Definition. An partial impairment of transmission of the cardiac electrical impulse along the fibers of the left bundle branch. (NCI) An electrocardiographic finding of a wide QRS complex with evidence of delayed conduction to the left ventricle, manifest as a widened initial portion of the QRS complex in leads V5, V6, I and aVL and with QRS duration < 120 ms. 6/28/2013 N/A II C71048 Definition SDTM-EGSTRESC ECG Result Update to Definition. Various mechanisms may result in a pattern showing an incomplete right bundle branch block (RBBB). These include different degrees of conduction delay through the main trunk of the right bundle branch; increased conduction time through an elongated right bundle branch; diffuse Purkinje-myocardial delay due to right ventricular stretch or dilatation; surgical trauma or disease-related interruption of the major ramifications of the right branch (distal RBBB or right fascicular blocks); congenital variations of the distribution of the major ramifications resulting in a slight delay in the activation of the crista supraventricularis. (NCI) An electrocardiographic finding of a wide QRS complex with evidence of delayed conduction to the right ventricle, manifest by a widened initial portion of the QRS in V1 and V2, a widened S wave in V5, V6, I and aVL, and with QRS duration less than 120 ms. 6/28/2013 N/A II C71048 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Incomplete right bundle branch block Incomplete right bundle branch block; Incomplete right bundle-branch block 6/28/2013 N/A II C71049 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. INCOMPLETE BUNDLE BRANCH BLOCK - - - 6/28/2013 N/A II C71050 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the electrical axis of the p wave is variable and the rate is greater than 100 beats per minute. To meet criteria for multifocal atrial tachycardia, the p wave must exhibit three distinct morphologies on the rhythm strip. (NCI) An electrocardiographic finding of a supraventricular arrhythmia characterized by 3 or more distinct P wave morphologies with an isoelectric baseline, variable PR intervals and no predominant atrial rhythm. The ventricular rate is typically 100-150 beats per minute. 6/28/2013 32199 II C71051 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the pacer of the heart is located in the AV junction, normally presenting with a narrow QRS complex and a rate of 60-100 beats per minute. (NCI) An electrocardiographic finding of a rhythm which originates in the AV junction and results in a normal heart rate. It is characterized by retrograde P waves which may be obscured by or may follow the QRS complexes. The QRS complexes may be narrow or may demonstrate aberration. 6/28/2013 N/A II C71053 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Non-sustained ventricular tachycardia Non-sustained ventricular tachycardia; Ventricular tachycardia, unsustained 6/28/2013 N/A II C71054 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. BIGEMINY VENTRICULAR BIGEMINY 6/28/2013 N/A II C71054 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of a normal QRS followed by a premature ventricular contraction; a rhythmic pairing of normal and abnormal beats originating in the ventricles in a 1-1 ratio. (NCI) An electrocardiographic finding of a normal QRS followed by a premature ventricular complex; a rhythmic pairing of normal and abnormal beats originating in the ventricles in a 1-1 ratio. 6/28/2013 N/A II C71054 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Bigeminy Ventricular Bigeminy 6/28/2013 N/A II C71055 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. TRIGEMINY VENTRICULAR TRIGEMINY 6/28/2013 N/A II C71055 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of normal QRS followed by a premature ventricular contraction; a rhythmic pairing of normal and abnormal beats originating from the ventricles in a 1-2 ratio. (NCI) An electrocardiographic finding of two sinus beats followed by a premature ventricular complex for 3 or more consecutive cycles; a regularly irregular rhythm of normal and abnormal QRS complexes in a 2-1 ratio. 6/28/2013 N/A II C71055 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Trigeminy Ventricular Trigeminy 6/28/2013 N/A II C71056 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. VENTRICULAR TACHYCARDIA STORM - - - 6/28/2013 N/A II C71057 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. ADENOSINE-SENSITIVE VENTRICULAR TACHYCARDIA - - - 6/28/2013 N/A II C71058 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. VERAPAMIL-SENSITIVE VENTRICULAR TACHYCARDIA - - - 6/28/2013 N/A II C71059 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. VENTRICULAR ARRHYTHMIA ASSOCIATED WITH BRUGADA SYNDROME - - - 6/28/2013 N/A II C71060 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. VENTRICULAR ARRHYTHMIA ASSOCIATED WITH SHORT QT SYNDROME - - - 6/28/2013 N/A II C71061 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. FASCICULAR TACHYCARDIA - - - 6/28/2013 N/A II C71062 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. BUNDLE BRANCH REENTRANT TACHYCARDIA - - - 6/28/2013 32204 II C71063 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. IDIOPATHIC RIGHT BUNDLE BRANCH BLOCK VENTRICULAR TACHYCARDIA - - - 6/28/2013 N/A II C71064 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. OUTFLOW TRACT VENTRICULAR TACHYCARDIA - - - 6/28/2013 N/A II C71065 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. ACUTE ANTERIOR WALL MI ACUTE ANTERIOR WALL MYOCARDIAL INFARCTION 6/28/2013 N/A II C71065 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the anterior wall of the heart. (NCI) An electrocardiographic finding of pathologic Q waves with accompanying ST elevation in leads V3 and V4, which is suggestive of acute myocardial infarction of the anterior wall of the left ventricle. 6/28/2013 N/A II C71065 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Acute Anterior Wall Myocardial Infarction Acute Anterior Myocardial Infarction by ECG Finding 6/28/2013 N/A II C71065 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Acute Anterior Wall Myocardial Infarction Acute Anterior Wall Myocardial Infarction; Acute Anterior MI 6/28/2013 N/A II C71066 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. ACUTE INFERIOR WALL MI ACUTE INFERIOR WALL MYOCARDIAL INFARCTION 6/28/2013 N/A II C71066 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the inferior wall of the heart. (NCI) An electrocardiographic finding of pathologic Q waves with accompanying ST elevation in leads III, aVF and often II, which is suggestive of acute myocardial infarction of the inferior wall of the left ventricle 6/28/2013 N/A II C71066 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Acute Inferior Wall Myocardial Infarction Acute Inferior Myocardial Infarction by ECG Finding 6/28/2013 N/A II C71066 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Acute Inferior Wall Myocardial Infarction Acute Inferior Wall Myocardial Infarction; Acute Inferior MI 6/28/2013 N/A II C71067 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. ACUTE LATERAL WALL MI ACUTE LATERAL WALL MYOCARDIAL INFARCTION 6/28/2013 N/A II C71067 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the lateral wall of the heart. (NCI) An electrocardiographic finding of pathologic Q waves with accompanying ST elevation in leads V5, V6, I and aVL , which is suggestive of acute myocardial infarction of the lateral wall of the left ventricle. 6/28/2013 N/A II C71067 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Acute Lateral Wall Myocardial Infarction Acute Lateral Myocardial Infarction by ECG Finding 6/28/2013 N/A II C71067 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Acute Lateral Wall Myocardial Infarction Acute Lateral Wall Myocardial Infarction; Acute Lateral MI 6/28/2013 N/A II C71068 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. ACUTE POSTERIOR WALL MI ACUTE POSTERIOR WALL MYOCARDIAL INFARCTION 6/28/2013 N/A II C71068 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the posterior wall of the heart. (NCI) An electrocardiographic finding in leads V1 or V2 of an initial R wave duration greater than or equal to 40 ms, R wave greater than S wave, upright T wave, with accompanying ST elevation, which is suggestive of acute myocardial infarction of the posterior wall of the left ventricle. Evidence of inferior or lateral myocardial infarction is usually also present. 6/28/2013 N/A II C71068 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Acute Posterior Wall Myocardial Infarction Acute Posterior Myocardial Infarction by ECG Finding 6/28/2013 N/A II C71068 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Acute Posterior Wall Myocardial Infarction Acute Posterior Wall Myocardial Infarction; Acute Posterior MI 6/28/2013 N/A II C71069 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the anterior wall of the heart. (NCI) An electrocardiographic finding of pathologic Q waves in leads V3 and V4, which is suggestive of myocardial infarction of the anterior wall of the left ventricle. 6/28/2013 N/A II C71069 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Anterior Wall Myocardial Infarction Anterior Myocardial Infarction by ECG Finding 6/28/2013 N/A II C71069 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Anterior Wall Myocardial Infarction Anterior Wall Myocardial Infarction; Anterior MI 6/28/2013 N/A II C71073 Definition SDTM-EGSTRESC ECG Result Update to Definition. A delay in impulse propagation through the atria. (NCI) An electrocardiographic finding of a delay in impulse propagation through the atria. This is characterized by broad P waves which are often biphasic in V1. 6/28/2013 32200 II C71074 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the pacer of the heart is located in the AV junction, normally presenting with a narrow QRS complex at a rate less than 60 beats per minute. (NCI) An electrocardiographic finding of a junctional rhythm with a heat rate which is abnormally low. 6/28/2013 N/A II C71076 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic findings suggestive of a hypertrophic left ventricle. (NCI) An electrocardiographic finding suggestive of a hypertrophied left ventricle, characterized by large QRS amplitudes and secondary findings of left atrial enlargement, left axis deviation, or typical pattern of ST depression and T wave inversion. 6/28/2013 N/A II C71076 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. EKG Finding Left Ventricular Hypertrophy Left Ventricular Hypertrophy by ECG Finding 6/28/2013 N/A II C71077 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic findings suggestive of an enlarged right ventricle. (NCI) An electrocardiographic finding suggestive of a hypertrophied right ventricle, characterized by large R wave amplitudes in the right precordial leads and secondary findings of right atrial enlargement, right axis deviation, and typical pattern of ST depression and T wave inversion in the right precordial leads. 6/28/2013 N/A II C71077 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. EKG Finding Right Ventricular Hypertrophy Right Ventricular Hypertrophy by ECG Finding 6/28/2013 N/A II C71078 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of a QRS amplitude less than or equal to 5mm in the limb leads or QRS amplitude less than or equal to 10mm in the precordial leads. (NCI) An electrocardiographic finding of a QRS amplitude less than or equal to 0.5 mV in the limb leads or QRS amplitude less than or equal to 1 mV in the precordial leads. 6/28/2013 N/A II C71080 Definition SDTM-EGSTRESC ECG Result Update to Definition. A myocardial infarction in the absence of observable Q wave abnormalities in the ECG. (NCI) An electrocardiographic finding of ST and T wave abnormalities in the absence of pathologic Q waves, which is suggestive of myocardial infarction in one or more regions of the heart. 6/28/2013 N/A II C71080 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Non Q Wave Myocardial Infarction Non Q Wave Myocardial Infarction by ECG Finding 6/28/2013 N/A II C71081 NCI C-code SDTM-EGSTRESC ECG Result NCI C-code change due to merge. C71081 C35399 6/28/2013 N/A II C71081 / C35399 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the posterior wall of the heart. (NCI) An electrocardiographic finding in leads V1 or V2 of an initial R wave duration greater than or equal to 40 ms, R wave greater than S wave, and upright T wave, which is suggestive of myocardial infarction of the posterior wall of the left ventricle. Evidence of inferior or lateral myocardial infarction is usually also present. 6/28/2013 N/A II C71081 / C35399 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Posterior Wall Myocardial Infarction Posterior Myocardial Infarction by ECG Finding 6/28/2013 N/A II C71081 / C35399 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Posterior Wall Myocardial Infarction Posterior Wall Myocardial Infarction; Posterior MI 6/28/2013 N/A II C71082 NCI C-code SDTM-EGSTRESC ECG Result NCI C-code change due to merge. C71082 C35519 6/28/2013 N/A II C71082 / C35519 Definition SDTM-EGSTRESC ECG Result Update to Definition. Electrocardiographic findings suggesting an infarction in the anatomic location of the cardiac septum. (NCI) An electrocardiographic finding suggesting an infarction in the anatomic location of the cardiac septum. (NCI) 6/28/2013 N/A II C71082 / C35519 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. Septal Myocardial Infarction Septal Myocardial Infarction by ECG Finding 6/28/2013 N/A II C71083 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. T WAVE ABNORMALITY - - - 6/28/2013 N/A II C71084 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. VENTRICULAR HYPERTROPHY - - - 6/28/2013 N/A II C71087 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the T wave is asymmetric. (NCI) An electrocardiographic finding of a T wave with both positive and negative components. 6/28/2013 N/A II C71089 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. U WAVES - - - 6/28/2013 N/A II C71090 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of a QRS complex. (NCI) An electrocardiographic finding of three or more consecutive wide QRS complexes of uncertain origin with a rate greater than a certain threshold (100 or 120 beats per minute are commonly used). 6/28/2013 32201 II C71090 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Wide QRS tachycardia Wide QRS tachycardia; Wide-QRS tachycardia 6/28/2013 N/A II C71094 Definition SDTM-EGSTRESC ECG Result Update to Definition. Q axis from -30 to -90 degrees. (NCI) An electrocardiographic finding of a frontal plane QRS axis from -30 to -90 degrees. 6/28/2013 N/A II C71094 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Q Axis, Left axis deviation Q Axis, Left axis deviation; Left-axis deviation; QRS axis, left axis deviation 6/28/2013 N/A II C71095 Definition SDTM-EGSTRESC ECG Result Update to Definition. Q axis from +90 to +180 degrees. (NCI) An electrocardiographic finding of a frontal plane QRS axis from +90 to +180 degrees. 6/28/2013 N/A II C71095 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Q Axis, Right axis deviation Q Axis, Right axis deviation; Right-axis deviation; QRS axis, right axis deviation 6/28/2013 N/A II C71096 NCI C-code SDTM-EGSTRESC ECG Result NCI C-code change due to incorrect coding. C71096 C107098 6/28/2013 N/A II C71096 / C107098 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. QTCB PROLONGATION >500 MSEC QTCB PROLONGATION 6/28/2013 N/A II C71096 / C107098 Definition SDTM-EGSTRESC ECG Result Update to Definition. Corrected QT interval longer than 500 msec, in accordance with Bazett's correction formula. (NCI) An electrocardiographic finding in which the QT interval corrected for heart rate using Bazett's formula is prolonged. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C71096 / C107098 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. QTcB Prolongation Greater Than 500 msec QTcB Prolongation 6/28/2013 N/A II C71096 / C107098 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. QTcB prolongation >500 PROLONGED QTcB 6/28/2013 N/A II C71097 NCI C-code SDTM-EGSTRESC ECG Result NCI C-code change due to incorrect coding. C71097 C107099 6/28/2013 N/A II C71097 / C107099 CDISC Submission Value SDTM-EGSTRESC ECG Result Update to CDISC Submission value. QTCF PROLONGATION >500 MSEC QTCF PROLONGATION 6/28/2013 N/A II C71097 / C107099 Definition SDTM-EGSTRESC ECG Result Update to Definition. Corrected QT interval greater than 500 msec, in accordance with Fridericia's correction formula. (NCI) An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula is prolonged. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C71097 / C107099 NCI Preferred Term SDTM-EGSTRESC ECG Result Update to NCI Preferred Term. QTcF Prolongation Greater Than 500 msec QTcF Prolongation 6/28/2013 N/A II C71097 / C107099 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. QTcF prolongation >500 msec PROLONGED QTcF 6/28/2013 N/A II C83817 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding of a QT interval corrected for heart rate that is prolonged. An electrocardiographic finding in which the QTc interval corrected for heart rate is prolonged. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C88140 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the cardiac rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. An electrocardiographic finding in which the cardiac rhythm is controlled by an electrical impulse from an artificial cardiac pacemaker. 6/28/2013 N/A II C90431 Definition SDTM-EGSTRESC ECG Result Update to Definition. P waves with two peaks longer in duration than normal and amplitude greater than normal. An electrocardiographic finding of P waves with two peaks longer in duration than normal and amplitude greater than normal. 6/28/2013 N/A II C90440 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding for the QRS complex that is atypical either for the shape, duration, amplitude, axis or polarity. (NCI) An electrocardiographic finding of a non-specific abnormality of the QRS complex, which is atypical in shape, duration, amplitude, axis or polarity. 6/28/2013 N/A II C90441 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. QRS COMPLEX ABSENT - - - 6/28/2013 N/A II C90443 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. R WAVE ABNORMALITY - - - 6/28/2013 N/A II C90444 Definition SDTM-EGSTRESC ECG Result Update to Definition. R wave variant in which there is a small deflection of the R wave, with changing polarity, within the QRS complex. (NCI) An electrocardiographic finding of an R wave variant in which there is a small deflection of the R wave, with changing polarity, within the QRS complex. (NCI) 6/28/2013 N/A II C90450 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. RESPIRATORY SINUS ARRHYTHMIA - - - 6/28/2013 N/A II C90451 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. S WAVE ABNORMALITY - - - 6/28/2013 N/A II C90483 Definition SDTM-EGSTRESC ECG Result Update to Definition. A compensatory ectopic beat that occurs in the ventricle after a pause in the ventricular rhythm, which is due to an absence in electrical activity to the ventricles. (NCI) An electrocardiographic finding of a compensatory ventricular complex that occurs following a prolonged RR interval. 6/28/2013 N/A II C90483 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Ventricular Escape Beat Ventricular Escape Beat; Ventricular escape complex(es) 6/28/2013 N/A II C92228 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the QTcB is approximately 430-470 msec. There is variation among subpopulations. An electrocardiographic finding in which the QT interval corrected for heart rate using Bazett's formula is slightly prolonged. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C92229 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the QTcF is approximately 430-470 msec. There is variation among subpopulations. An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula is slightly prolonged. Thresholds for different age, gender, and patient populations exist. 6/28/2013 N/A II C92230 Term SDTM-EGSTRESC ECG Result Retire CDISC controlled term. EARLY R WAVE PROGRESSION - - - 6/28/2013 N/A II C92232 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which both the atrial and ventricular rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. An electrocardiographic finding in which both the atrial and ventricular rhythm are controlled by an electrical impulse from an artificial cardiac pacemaker. 6/28/2013 N/A II C92232 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Paced Atrial And Ventricular Rhythm Paced Atrial And Ventricular Rhythm; AV dual-paced complex(es) or rhythm 6/28/2013 N/A II C92233 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the atrial rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. An electrocardiographic finding in which the atrial rhythm is controlled by an electrical impulse from an artificial cardiac pacemaker. 6/28/2013 N/A II C92233 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Paced Atrial Rhythm Paced Atrial Rhythm; Atrial-paced complex(es) or rhythm 6/28/2013 N/A II C92234 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which the ventricular rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. An electrocardiographic finding in which the ventricular rhythm is controlled by an electrical impulse from an artificial cardiac pacemaker. 6/28/2013 N/A II C92234 Synonym SDTM-EGSTRESC ECG Result Addition of synonym. Paced Ventricular Rhythm Paced Ventricular Rhythm; Ventricular-paced complex(es) or rhythm 6/28/2013 N/A II C92235 Definition SDTM-EGSTRESC ECG Result Update to Definition. An electrocardiographic finding in which there is evidence that electrical transmission through the right ventricle is impaired. An electrocardiographic finding in which there is evidence that electrical transmission through the right ventricle is impaired with a maximal QRS duration of 110 ms and which does not meet the criteria for Incomplete Right Bundle Branch Block. 6/28/2013 32766 II C17423 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. Modern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to the body. (FDA) Modern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to the body. 6/28/2013 32766 II C29167 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. An emulsion, liquid (1) dosage form. This dosage form is generally for external application to the skin (2). Note 1: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Note 2: Previously the definition of a lotion was: The term lotion has been used to categorize many topical suspensions, solutions, and emulsions intended for application to the skin. The current definition of a lotion is restricted to an emulsion. (FDA) An emulsion, liquid (1) dosage form. This dosage form is generally for external application to the skin (2). Note 1: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Note 2: Previously the definition of a lotion was: The term lotion has been used to categorize many topical suspensions, solutions, and emulsions intended for application to the skin. The current definition of a lotion is restricted to an emulsion. 6/28/2013 32766 II C42678 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A narrow tube filled with material that is capable to burn with release of therapeutically-active substance(s) during the process of smoking. Cigarette is a very efficient drug-delivery inhaler system for fast-acting substances. (FDA) A narrow tube filled with material that is capable to burn with release of therapeutically-active substance(s) during the process of smoking. Cigarette is a very efficient drug-delivery inhaler system for fast-acting substances. 6/28/2013 32766 II C42763 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. The application of various materials for protecting a wound.(FDA) The application of various materials for protecting a wound. 6/28/2013 32766 II C42887 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). (FDA) A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). 6/28/2013 32766 II C42888 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A dosage form containing one or more active ingredients, surfactants, aqueous or non-aqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged. (FDA) A dosage form containing one or more active ingredients, surfactants, aqueous or non-aqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged. 6/28/2013 32766 II C42895 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating. (FDA) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating. 6/28/2013 32766 II C42901 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A naturally produced angular solid of definite form in which the ultimate units from which it is built up are systematically arranged; they are usually evenly spaced on a regular space lattice. (FDA) A naturally produced angular solid of definite form in which the ultimate units from which it is built up are systematically arranged; they are usually evenly spaced on a regular space lattice. 6/28/2013 32766 II C42904 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines. (FDA) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines. 6/28/2013 32766 II C42910 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration. (FDA) A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration. 6/28/2013 32766 II C42914 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally. (FDA) An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally. 6/28/2013 32766 II C42917 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (FDA) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. 6/28/2013 32766 II C42928 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (FDA) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. 6/28/2013 32766 II C42930 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion. (FDA) A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion. 6/28/2013 32766 II C42934 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. (FDA) A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. 6/28/2013 32766 II C42935 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solution that forms a gel when it comes in contact with ocular fluid, and which allows at least a reduction in dosing frequency. (FDA) A solution that forms a gel when it comes in contact with ocular fluid, and which allows at least a reduction in dosing frequency. 6/28/2013 32766 II C42943 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding; they are intended for implantation in the body (usually subcutaneously) for the purpose of providing continuous release of the drug over long periods of time. (FDA) A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding; they are intended for implantation in the body (usually subcutaneously) for the purpose of providing continuous release of the drug over long periods of time. 6/28/2013 32766 II C42950 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. [definition pending](FDA) [definition pending] 6/28/2013 32766 II C42953 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A dosage form consisting of a pure chemical in its liquid state. This dosage form term should not be applied to solutions. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior.(FDA) A dosage form consisting of a pure chemical in its liquid state. This dosage form term should not be applied to solutions. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. 6/28/2013 32766 II C42955 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.(FDA) A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick. 6/28/2013 32766 II C42958 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A liquid preparation, intended for parenteral use, that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures. (FDA) A liquid preparation, intended for parenteral use, that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures. 6/28/2013 32766 II C42966 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. (FDA) A suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. 6/28/2013 32766 II C42968 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. (FDA) A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. 6/28/2013 32766 II C42970 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. Substance intended for external application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin. (FDA) Substance intended for external application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin. 6/28/2013 32766 II C42977 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A dried preparation intended for reconstitution to form a suspension for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution). (FDA) A dried preparation intended for reconstitution to form a suspension for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution). 6/28/2013 32766 II C42986 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A clear, homogeneous liquid dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. (FDA) A clear, homogeneous liquid dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. 6/28/2013 32766 II C42993 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid body of various weights and shapes, adapted for introduction into the rectal, vaginal, or urethral orifice of the human body; they usually melt, soften, or dissolve at body temperature. (FDA) A solid body of various weights and shapes, adapted for introduction into the rectal, vaginal, or urethral orifice of the human body; they usually melt, soften, or dissolve at body temperature. 6/28/2013 32766 II C42994 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. (FDA) A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. 6/28/2013 32766 II C43525 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A circular plate-like organ or structure. (FDA) A circular plate-like organ or structure. 6/28/2013 32766 II C45413 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A material applied to the inside of the dental cavity, for protection or insulation of the surface. (FDA) A material applied to the inside of the dental cavity, for protection or insulation of the surface. 6/28/2013 32766 II C47887 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A material, usually covered by or impregnated with a drug, that is inserted into a body cavity or between the tooth enamel and the gingival margin. (FDA) A material, usually covered by or impregnated with a drug, that is inserted into a body cavity or between the tooth enamel and the gingival margin. 6/28/2013 32766 II C47898 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing. (FDA) A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing. 6/28/2013 32766 II C47912 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape. (FDA) A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape. 6/28/2013 32766 II C47914 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A long narrow piece of material. (FDA) A long narrow piece of material. 6/28/2013 32766 II C60884 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing. (FDA) A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing. 6/28/2013 32766 II C60897 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A cream dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. (FDA) A cream dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. 6/28/2013 32766 II C60926 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A slender and elongated solid thread-like substance that delivers drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (FDA) A slender and elongated solid thread-like substance that delivers drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. 6/28/2013 32766 II C60927 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A product, usually a solid, intended for solution prior to administration. (FDA) A product, usually a solid, intended for solution prior to administration. 6/28/2013 32766 II C60928 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A product, usually a solid, intended for suspension prior to administration. (FDA) A product, usually a solid, intended for suspension prior to administration. 6/28/2013 32766 II C60929 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified period. (FDA) A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified period. 6/28/2013 32766 II C60930 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation. (FDA) A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation. 6/28/2013 32766 II C60931 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. An injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance). (FDA) An injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance). 6/28/2013 32766 II C60933 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects. (FDA) A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects. 6/28/2013 32766 II C60934 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A liquid that delivers a drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (FDA) A liquid that delivers a drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. 6/28/2013 32766 II C60957 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A lotion dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. (FDA) A lotion dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. 6/28/2013 32766 II C60958 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents. (FDA) A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents. 6/28/2013 32766 II C60984 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. An ointment dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. (FDA) An ointment dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. 6/28/2013 32766 II C60985 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth. (FDA) An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth. 6/28/2013 32766 II C60988 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects. (FDA) A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects. 6/28/2013 32766 II C60992 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solution which is usually administered in a drop-wise fashion. (FDA) A solution which is usually administered in a drop-wise fashion. 6/28/2013 32766 II C60994 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solution, which after usually being administered in a drop-wise fashion, forms a gel. (FDA) A solution, which after usually being administered in a drop-wise fashion, forms a gel. 6/28/2013 32766 II C60995 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A suspension which is usually administered in a dropwise fashion. (FDA) A suspension which is usually administered in a dropwise fashion. 6/28/2013 32766 II C60997 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid dosage form containing a conglomerate of medicinal particles that have each been covered with a coating. (FDA) A solid dosage form containing a conglomerate of medicinal particles that have each been covered with a coating. 6/28/2013 32766 II C61004 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A tablet that forms a solution when placed in a liquid. (FDA) A tablet that forms a solution when placed in a liquid. 6/28/2013 32766 II C61005 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A tablet that forms a suspension when placed in a liquid (formerly referred to as a Dispersible Tablet). (FDA) A tablet that forms a suspension when placed in a liquid (formerly referred to as a Dispersible Tablet). 6/28/2013 32766 II C61006 Definition SDTM-FRM Pharmaceutical Dosage Form Remove attribution from end of definition. A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration. (FDA) A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration. 6/28/2013 32471 III C100421 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Retire CDISC controlled term. Duplicate to C98862. APTTSPTT / Activated PTT/Standard PTT - - - 6/28/2013 32449 III C106498 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: ALTAST; ALT/AST 6/28/2013 32415 III C106499 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: AFPA; Alpha Fetoprotein Activity 6/28/2013 32427 III C106504 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: YEASTBUD; Yeast Budding 6/28/2013 32415 III C106505 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: CA72_4AG; Cancer Antigen 72-4 6/28/2013 32496 III C106509 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: CLCLR; Chloride Clearance 6/28/2013 N/A III C106511 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: CRTCREAT; Corticosterone/Creatinine 6/28/2013 N/A III C106512 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: CORCREAT; Cortisol/Creatinine 6/28/2013 N/A III C106513 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: CYSCREAT; Cystatin C/Creatinine 6/28/2013 32415 III C106514 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: CYFRA211; Cytokeratin Fragment 21-1 6/28/2013 32480 III C106518 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: EBN1IGAB; Epstein-Barr Nuclear Antigen 1 IgG Ab 6/28/2013 32427 III C106519 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: EBVINTP; EBV Profile Interpretation 6/28/2013 N/A III C106521 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: FABP3; Fatty Acid Binding Protein 3 6/28/2013 N/A III C106525 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: HDW; Hemoglobin Distribution Width 6/28/2013 N/A III C106526 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: HEIGGAB; Hepatitis E Virus IgG Antibody 6/28/2013 32427 III C106527 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: HIVAB; HIV Antibody 6/28/2013 N/A III C106535 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: BLSTIMLY; Immunoblasts/Lymphocytes 6/28/2013 N/A III C106537 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: GIPI; Glucose-dep Insulinotropic Pep, Intact 6/28/2013 N/A III C106539 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: LCN2; Lipocalin-2 6/28/2013 N/A III C106540 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: LCN2CREA; Lipocalin-2/Creatinine 6/28/2013 N/A III C106544 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: MONOMA; Monocytes/Macrocytes 6/28/2013 N/A III C106546 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: MGBCREAT; Myoglobin/Creatinine 6/28/2013 32496 III C106547 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: MYL3; Myosin Light Chain 3 6/28/2013 32496 III C106553 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: PHOSCLR; Phosphate Clearance 6/28/2013 32496 III C106560 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: KCLR; Potassium Clearance 6/28/2013 32496 III C106568 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: NACLR; Sodium Clearance 6/28/2013 32473 III C106569 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: SPWEIGHT; Specimen Weight 6/28/2013 N/A III C106574 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: TAT; Thrombin/Antithrombin 6/28/2013 N/A III C106575 Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: TIMP1CRE; TIMP1/Creatinine 6/28/2013 N/A II C64800 Synonym SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Addition of synonym. Erythrocytes Distribution Width Erythrocytes Distribution Width; Red Blood Cell Distribution Width 6/28/2013 N/A II C74683 Definition SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Update to Definition. A measurement of the triple phosphate crystals present in a biological specimen. A measurement of the tyrosine crystals present in a biological specimen. 6/28/2013 32479 II C96603 Synonym SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Addition of synonym. Epstein-Barr Nuclear Antibody Epstein-Barr Nuclear Antibody; Epstein-Barr Nuclear Antigen Antibody 6/28/2013 32471 II C98862 Synonym SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Addition of synonym. Activated PTT/Standard Activated PTT/Standard; Activated PTT/Standard PTT; Activated Partial Thromboplastin Time/Standard Thromboplastin Time 6/28/2013 N/A II C98869 NCI Preferred Term SDTM-LBTESTCD; SDTM-LBTEST Laboratory Test Name; Laboratory Test Code Update to NCI Preferred Term. Plasma Cell to Total CellRatio Measurement Plasma Cell to Total Cell Ratio Measurement 6/28/2013 32520 II C85656 Definition SDTM-PKPARM; SDTM-PKPARMCD PK Parameters; PK Parameters Code Update to Definition. The last measurable (positive) excretion rate. The last measurable (positive) excretion rate determined for the specimen type specified in PPSPEC. 6/28/2013 32520 II C85699 Definition SDTM-PKPARM; SDTM-PKPARMCD PK Parameters; PK Parameters Code Update to Definition. The maximum excretion rate. The maximum excretion rate determined for the specimen type specified in PPSPEC. 6/28/2013 N/A III C106528 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: h2*umol/L 6/28/2013 N/A III C106529 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: h2*pmol/L 6/28/2013 N/A III C106530 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: h*mmol/L/g 6/28/2013 N/A III C106531 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: h*mol/L/g 6/28/2013 N/A III C106532 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: h*pmol/L/g 6/28/2013 N/A III C106543 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: min*pmol/L 6/28/2013 N/A III C25613 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: % 6/28/2013 N/A III C44256 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: RATIO 6/28/2013 N/A II C48555 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. mmol/mL mol/L 6/28/2013 N/A II C64387 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. umol/mL mmol/L 6/28/2013 N/A III C67432 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: nmol/L 6/28/2013 N/A III C67434 Term SDTM-PKUNIT PK Parameter Units of Measure Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: pmol/L 6/28/2013 N/A II C85587 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. day*umol/mL day*mmol/L 6/28/2013 N/A II C85587 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Days times micromoles per milliliter. Days times millimoles per liter (area under the curve). 6/28/2013 N/A II C85589 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. day*mmol/mL day*mol/L 6/28/2013 N/A II C85589 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Days times millimoles per milliliter. Days times moles per liter (area under the curve). 6/28/2013 N/A II C85592 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. day*nmol/mL day*umol/L 6/28/2013 N/A II C85592 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Days times nanomoles per milliliter. Days times micromoles per liter (area under the curve). 6/28/2013 N/A II C85594 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. day*pmol/mL day*nmol/L 6/28/2013 N/A II C85594 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Days times picomoles per milliliter. Days times nanomoles per liter (area under the curve). 6/28/2013 N/A II C85605 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h2*umol/mL h2*mmol/L 6/28/2013 N/A II C85605 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours squared times micromoles per milliliter. Hours squared times millimoles per liter (area under the moment curve). 6/28/2013 N/A II C85607 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h2*mmol/mL h2*mol/L 6/28/2013 N/A II C85607 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours squared times millimoles per milliliter. Hours squared times moles per liter (area under the moment curve). 6/28/2013 N/A II C85610 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h2*pmol/mL h2*nmol/L 6/28/2013 N/A II C85610 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours squared times picomoles per milliliter. Hours squared times nanomoles per liter (area under the moment curve). 6/28/2013 N/A II C85612 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h*fmol/mL h*pmol/L 6/28/2013 N/A II C85612 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours times femtomoles per milliliter. Hours times picomoles per liter (area under the curve). 6/28/2013 N/A II C85618 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h*umol/mL h*mmol/L 6/28/2013 N/A II C85618 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours times micromoles per milliliter. Hours times millimoles per liter (area under the curve). 6/28/2013 N/A II C85622 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h*mmol/mL h*mol/L 6/28/2013 N/A II C85622 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours times millimoles per milliliter. Hours times moles per liter (area under the curve). 6/28/2013 N/A II C85629 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h*ng/mL/mg/m2 h*ng/mL/(mg/m2) 6/28/2013 N/A II C85629 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. "Hours times nanograms per milligram per meter squared. " "Hours times nanograms per milliliter (area under the curve), divided by milligram per meter squared (dose normalized by surface area). " 6/28/2013 N/A II C85629 Synonym SDTM-PKUNIT PK Parameter Units of Measure Removal of synonym. h*ng/mL/mg/m^2; h*ng/mL/mg/m*m; ng*h/mL/mg/m2 - - - 6/28/2013 N/A II C85632 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h*nmol/mL h*umol/L 6/28/2013 N/A II C85632 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours times nanomoles per milliliter. Hours times micromoles per liter (area under the curve). 6/28/2013 N/A II C85634 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h*nmol/mL/mg h*umol/L/g 6/28/2013 N/A II C85634 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours times nanomoles per milliliter per milligram. Hours times micromoles per liter (area under the curve), divided by grams (dose or body weight). 6/28/2013 N/A II C85640 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h*pmol/mL h*nmol/L 6/28/2013 N/A II C85640 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours times picomoles per milliliter. Hours times nanomoles per liter (area under the curve). 6/28/2013 N/A II C85641 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. h*pmol/mL/mg h*nmol/L/g 6/28/2013 N/A II C85641 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Hours times picomoles per milliliter per milligram. Hours times nanomoles per liter (area under the curve), divided by grams (dose or body weight. 6/28/2013 N/A II C85728 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. min*umol/mL min*mmol/L 6/28/2013 N/A II C85728 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Minutes times micromoles per milliliter. Minutes times millimoles per liter (area under the curve). 6/28/2013 N/A II C85730 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. min*mmol/mL min*mol/L 6/28/2013 N/A II C85730 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Minutes times millimoles per milliliter. Minutes times moles per liter (area under the curve). 6/28/2013 N/A II C85733 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. min*nmol/mL min*umol/L 6/28/2013 N/A II C85733 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Minutes times nanomoles per milliliter. Minutes times micromoles per liter (area under the curve). 6/28/2013 N/A II C85735 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. min*pmol/mL min*nmol/L 6/28/2013 N/A II C85735 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Minutes times picomoles per milliliter. Minutes times nanomoles per liter (area under the curve). 6/28/2013 N/A II C85748 Term SDTM-PKUNIT PK Parameter Units of Measure Retire CDISC controlled term. ng/mL*kg - - - 6/28/2013 N/A II C85756 CDISC Submission Value SDTM-PKUNIT PK Parameter Units of Measure Update to CDISC Submission value. nmol/mL umol/L 6/28/2013 N/A II C85756 Definition SDTM-PKUNIT PK Parameter Units of Measure Update to Definition. Nanomoles per milliliter. A unit of concentration (molarity unit) equal to one micromole of solute per one liter of solution. 6/28/2013 N/A III C106524 Term SDTM-UNIT Unit Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: Frames/s 6/28/2013 N/A III C106542 Term SDTM-UNIT Unit Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: mL/mmHg 6/28/2013 N/A II C73777 Definition SDTM-UNIT Unit Update to Definition. An arbitrary unit of substance rate expressed in unit(s) per gram per period of time equal to twenty-four hours. (NCI) An arbitrary unit of substance rate expressed in unit(s) per kilogram per period of time equal to twenty-four hours. (NCI) 6/28/2013 N/A II C73778 Definition SDTM-UNIT Unit Update to Definition. An arbitrary unit of substance rate expressed in unit(s) per gram per period of time equal to sixty minutes. (NCI) An arbitrary unit of substance rate expressed in unit(s) per kilogram per period of time equal to sixty minutes. (NCI) 6/28/2013 N/A II C73779 Definition SDTM-UNIT Unit Update to Definition. An arbitrary unit of substance rate expressed in unit(s) per gram per period of time equal to sixty seconds. (NCI) An arbitrary unit of substance rate expressed in unit(s) per kilogram per period of time equal to sixty seconds. (NCI) 6/28/2013 31798 III C104622 Term SDTM-VSTEST; SDTM-VSTESTCD Vital Signs Test Code; Vital Signs Test Name Create New Term. - - - See published spreadsheet for new term information. CDISC Submission Value: TBW; Total Body Water 6/28/2013 N/A II C81255 Definition SDTM-VSTEST; SDTM-VSTESTCD Vital Signs Test Code; Vital Signs Test Name Update to Definition. A circumferential measurement of the head at the widest point, which is traditionally above the eyebrows. A circumferential measurement of the head at the widest point.