Toxicity grading scales provide consistency in reporting, and provide a framework for assessment and documentation of adverse effects. Objective assessment of the impact of treatment may inform the need for adjustments to the treatment plan.
CTCAE (Common Terminology Criteria for Adverse Events) is a list of adverse event (AE) terms commonly encountered in oncology. Each AE term is defined and accompanied by a grading scale that indicates the severity of the AE. With the availability of new agents and the multimodality interventions, it is critical to systematically monitor the AEs that are linked to oncology research. CTCAE is intended to be an agreed on terminology for the designation, reporting and grading of AEs that occur in oncology research.44
CTCAE serves several purposes, such as:44
- to standardise AE reporting within the NCI oncology research community, across groups and modalities
- to facilitate the evaluation of new cancer therapies, treatment modalities, and supportive measures
- to aid in AE recognition and severity grading
- to monitor safety data and for regulatory reporting
- to define oncology research protocol parameters (eg. eligibility criteria; dose limiting toxicity; maximum tolerated dose; dose modification).
Access the Common Terminology Criteria for Adverse Events (CTCAE) (PDF, 2.9MB)45, and provide a clinical example of how the use of objective criteria facilitates safe and effective care.