The NCI Common Terminology Criteria for Adverse Events v3.0 (CTCAE) is a descriptive terminology used for reporting adverse events (AEs). It includes a grading scale for each AE term, ranging from Grade 1 (mild) to Grade 5 (death-related). The criteria are organized into categories based on anatomy and pathophysiology, with each category listing AEs and their severity grades. Key components include: - **CATEGORY**: Broad classification of AEs. - **Adverse Event Terms**: Unique representations of specific events, mapped to MedDRA terms and codes. - **SHORT NAME**: Simplifies AE documentation. - **Supra-ordinate Terms**: Grouping terms for related AEs, not mapped to MedDRA terms. - **REMARK**: Clarifications for AEs. - **ALSO CONSIDER**: Additional AEs to be graded if clinically significant. - **NAVIGATION NOTE**: Location of AE terms within the document. - **Grades**: Descriptions of AE severity, with specific guidelines for each grade. The document covers various categories such as Allergy/Immunology, Auditory/Ear, Blood/Bone Marrow, Cardiac Arrhythmia, and more. It also provides detailed guidelines for specific conditions, such as drug-induced ototoxicity, distinguishing it from age-related threshold decrements.The NCI Common Terminology Criteria for Adverse Events v3.0 (CTCAE) is a descriptive terminology used for reporting adverse events (AEs). It includes a grading scale for each AE term, ranging from Grade 1 (mild) to Grade 5 (death-related). The criteria are organized into categories based on anatomy and pathophysiology, with each category listing AEs and their severity grades. Key components include: - **CATEGORY**: Broad classification of AEs. - **Adverse Event Terms**: Unique representations of specific events, mapped to MedDRA terms and codes. - **SHORT NAME**: Simplifies AE documentation. - **Supra-ordinate Terms**: Grouping terms for related AEs, not mapped to MedDRA terms. - **REMARK**: Clarifications for AEs. - **ALSO CONSIDER**: Additional AEs to be graded if clinically significant. - **NAVIGATION NOTE**: Location of AE terms within the document. - **Grades**: Descriptions of AE severity, with specific guidelines for each grade. The document covers various categories such as Allergy/Immunology, Auditory/Ear, Blood/Bone Marrow, Cardiac Arrhythmia, and more. It also provides detailed guidelines for specific conditions, such as drug-induced ototoxicity, distinguishing it from age-related threshold decrements.