Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Published: May 28, 2009 (V4.03: June 14, 2010)
1. CTCAE 4.03 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Published: May 28, 2009 (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) Publish Date: May 28, 2009 Quick Reference Definitions Not all Grades are appropriate for all AEs. The NCI Common Terminology Criteria for A brief definition is provided to clarify the Therefore, some AEs are listed with fewer than Adverse Events is a descriptive terminology which meaning of each AE term. five options for Grade selection. can be utilized for Adverse Event (AE) reporting. Grade 5 A grading (severity) scale is provided for each AE Grades term. Grade refers to the severity of the AE. The CTCAE Grade 5 (Death) is not appropriate for some AEs displays Grades 1 through 5 with unique clinical and therefore is not an option. Components and Organization descriptions of severity for each AE based on this Activities of Daily Living (ADL) SOC general guideline: *Instrumental ADL refer to preparing meals, System Organ Class, the highest level of the Grade 1 Mild; asymptomatic or mild shopping for groceries or clothes, using the MedDRA hierarchy, is identified by anatomical or symptoms; clinical or diagnostic telephone, managing money, etc. physiological system, etiology, or purpose (e.g., observations only; intervention not SOC Investigations for laboratory test results). indicated. **Self care ADL refer to bathing, dressing and CTCAE terms are grouped by MedDRA Primary Grade 2 Moderate; minimal, local or undressing, feeding self, using the toilet, taking SOCs.
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