Diastolic Blood Pressure C25299 CDISC VSTESTCD = “ DIABP ”

1. Property or Attribute C35552 The distinguishing qualities or prominent aspect of a person, object, action, process, or substance. Personal Attribute C19332 The distinguishing qualities or prominent aspects of an individual person. The pressure of the circulating blood against the walls of the blood vessels. Blood Pressure C54706 The blood pressure after the contraction of the heart while the chambers of the heart refill with blood. Diastolic Blood Pressure C25299 CDISC VSTESTCD = “DIABP” NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

2. Any specific activity undertaken during the course of a clinical study or research protocol. Clinical or Research Activity C16203 Activity or measure that produces an effect or that is intended to alter the course of a disease in patient or population. This is a general term encompassing medical, social, behavioral, environmental and other acts that can have preventive and/or therapeutic impact. . Intervention or Procedure C25218 A medical procedure that involves testing a sample of blood, urine, or other substance from the body. Tests can help determine a diagnosis, plan treatment, check to see if treatment is working, or monitor the disease over time. Laboratory Procedure C25294 Chemistry Test C49237 Protein or Enzyme Type Measurement C64430 CDISC Definition: A measurement of the Choriogonadotropin Beta in a biological specimen. NCI Defintion: A determination of the presence of Choriogonadotropin Beta protein. Choriogonadotropin Beta Measurement C64851 CDISC LBTESTCD = “HCG”Synonym: “Pregnancy Test” NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

3. Specification of human conditions relevant to cancer. This includes observations, test results, history, and other concepts relevant to characterization of human cancer-related conditions. Non-neoplastic conditions of interest are also included. Disease, Disorder or FindingC7057 Objective evidence of disease perceptible to the examining physician (sign) and subjective evidence of disease perceived by the patient (symptom).. Finding C3367 Finding by Site or System C36278 Cardiovascular System Finding C35552 Patient complaints (symptoms), physical/laboratory findings(signs) related to the cardiovascular system. Blood Pressure Finding C54707 A test result that reports the diastolic and systolic pressure of the blood. Pathological increase in blood pressure; a repeatedly elevated blood pressure exceeding 140 over 90 mmHg Hypertension C3117 Postpartum Hypertension C35802 NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

4. CDISC SDTM and related initativies All terms and conceptsare incorporated from NCI Thesaurus thorugh NCI EVS SDTM variables specifiedas packages of ControlledTerminologies Published as an Excel matrixeson CDISC website In OWL format NCI Thesaurus CDISCClinical Data Interchange Standards Consortium UMLS RCRIM Regulated Clinical Research and Information Management,technical committee Relationship HL7/CDISC BRIDGBiomedical Research Integrated Domain Group Model HL7 “Health Level Seven”

5. CDISC’s Controlled Terminoligy for VSTEST Codesas part of package 1 Published as an Excel matrixeson CDISC website

6. Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes Personal Attribute Action Property or Attribute Conceptual Entities Anatomic StructureSystem or Substance Finding by Site or System Body Frame Size“FRMSIZE” Blood Pressure Body Mass Index“BMI” Body Surface Area“BSA” Observation Characteristic Temperature“TEMP” Microanatomic Structure Cardiovascular System Finding Diastolic Pressure “DIABP” Systolic Pressure “SYSBP” Vital Signs Test Name Weight“WEIGHT” Height“HEIGHT” Tissue Heart Rate“HR” Pulse Rate“PULSE” Respiratory Rate“RESP” Connective and Soft Tissue Blood Pressure Finding Soft Tissue Mean Arterial Pressure“MAP” Adipose Tissue“BODYFAT” NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

7. Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes Personal Attribute Action Property or Attribute Conceptual Entities Anatomic StructureSystem or Substance Finding by Site or System Body Frame Size“FRMSIZE” Blood Pressure Body Mass Index“BMI” Body Surface Area“BSA” Observation Characteristic Temperature“TEMP” Microanatomic Structure Cardiovascular System Finding Diastolic Pressure “DIABP” Systolic Pressure “SYSBP” Vital Signs Test Name Weight“WEIGHT” Height“HEIGHT” Tissue Heart Rate“HR” Pulse Rate“PULSE” Respiratory Rate“RESP” Connective and Soft Tissue Blood Pressure Finding Soft Tissue Mean Arterial Pressure“MAP” The blood pressure after the contraction of the heart while the chambers of the heart refill with blood. Adipose Tissue“BODYFAT” NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

8. Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes Personal Attribute Action Property or Attribute Conceptual Entities Anatomic StructureSystem or Substance Finding by Site or System Body Frame Size“FRMSIZE” Blood Pressure Body Mass Index“BMI” Body Surface Area“BSA” Observation Characteristic Temperature“TEMP” Microanatomic Structure Cardiovascular System Finding (Pulse) Diastolic Pressure “DIABP” Systolic Pressure “SYSBP” Vital Signs Test Name Weight“WEIGHT” Height“HEIGHT” Tissue Heart Rate“HR” Pulse Rate“PULSE” Respiratory Rate“RESP” Connective and Soft Tissue Blood Pressure Finding The rhythmic wave within the arteries occurring with each contraction ofthe left ventricle. Soft Tissue Mean Arterial Pressure“MAP” The rate of the pulse as observed in an artery, expressed as beats per minute. It can be measured at several anatomical sites, including the wrist, neck, temple, groin, behind the knees, or on top of the foot. Adipose Tissue“BODYFAT” NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

9. Generic dataset structure for all domainsBased on the descriptions in the Study Data Tabulation Model document RecordQual Topic Identifier Timing GroupingQual SynonymQual Res ResQual Var VarQual VSPOS VSLOC VSTESTCD VSORRES Res Example from CDISC SDTM Implementation Guideline version 3.1.2

10. Hypertension can be seen as a Risk Factor in SDTM Medical History for a specific clinical study A CRF (Case Report Form) asks whether or not the subject had any of a list of 4 specific risk factors, including hypertension, and there is a space for the investigator to write in other risk factors. In SDTM this is classified as a Medical History and below is an example on row 7 describing how a (sligfhly simplified) record in a MH domain could look like Example from CDISC SDTM Implementation Guideline version 3.1.2

11. Pregnancy can be seen as a type of Disposition event in SDTM domain for Disposition for a specific clinical study From CDISC SDTM Implementation Guideline version 3.1.2, to be published as a controlled terminioligy

12. Primary use inDrug Development (i.e. Secondary Use of Health Care data in clinical research) Primary Usein Health Careper patient Secondary Usein Health Careas Knowledge Base Population Subject SDTM Auhortities Organizing clinical trials information that is to be submitted to the FDA. Patient Secondary UseEpi / Population / Real life analysis Secondary Usein Drug Developmentas Knowledge Base