tailieunhanh - Sách: Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Tit Albreht MD PhD is a researcher in health services at the Institute of Public Health of the Republic of Slovenia, where he holds the post of Adviser to the Director. He is involved in teaching at the Department of Public Health. He trained at the Medical Faculty, University of Ljubljana, Slovenia. After completing his training in the specialty of social medicine and his Masters and Doctorate of Science at the Netherlands Institute for Health Sciences at Erasmus University, Rotterdam (in the area of health services research), his research has focused on health systems and health policy development issues at both national and international level. He is. | Common Terminology Criteria for Adverse Events CTCAE Publish Date August 9 2006 Quick Reference The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event AE reporting. A grading severity scale is provided for each AE term. Components and Organization CATEGORY A CATEGORY is a broad classification of AEs based on anatomy and or pathophysiology. Within each CATEGORY AEs are listed accompanied by their descriptions of severity Grade . Adverse Event Terms An AE is any unfavorable and unintended sign including an abnormal laboratory finding symptom or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. An AE is a term that is a unique representation of a specific event used for medical documentation and scientific analyses. Each AE term is mapped to a MedDRA term and code. AEs are listed alphabetically within CATEGORIES. Short AE Name The Short Name column is new and it is used to simplify documentation of AE names on Case Report Forms. Supra-ordinate Terms A supra-ordinate term is located within a CATEGORY and is a grouping term based on disease process signs symptoms or diagnosis. A supra-ordinate term is followed by the word Select and is accompanied by specific AEs that are all related to the supra-ordinate term. Supra-ordinate terms provide clustering and consistent representation of Grade for related AEs. Supra-ordinate terms are not AEs are not mapped to a MedDRA term and code cannot be graded and cannot be used for reporting. Remark A REMARK is a clarification of an AE. Also Consider An ALSO CONSIDER indicates additional AEs that are to be graded if they are clinically significant. Navigation Note A Navigation Note indicates the location of an AE term within the CTCAE document. It lists signs symptoms alphabetically and the CTCAE term will appear in the same category unless the .