Common Terminology Criteria for Adverse Events (CTCAE)

Common Terminology Criteria for Adverse Events (CTCAE)

The NCI’s Common Terminology Criteria for Adverse Events (CTCAE; http://ctep.cancer.gov/reporting/ctc.html) is a longstanding empirically developed “dictionary” or lexicon, designed for use in clinical trials to aid clinicians in detecting and documenting an array of adverse events (AEs) commonly encountered in oncology.

An AE is a term that is a unique representation of a specific event used for medical documentation and scientific analyses. Each AE is graded on a scale of 1 (mild) to 5 (death related to AE).

There is growing awareness that collecting symptom data directly from patients using patient-reported outcome (PRO) tools can improve the accuracy and efficiency of symptomatic AE data collection.

The NCI’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) system provides a web-based platform to collect patient reports of symptoms they are experiencing while undergoing treatment for the purpose of enhancing adverse event (AE) reporting http://outcomes.cancer.gov/tools/pro-ctcae.html). To date, 81 symptoms of the CTCAE (version 4) have been identified to be amenable to patient reporting. These symptoms have been converted to patient terms (e.g., CTCAE term “myalgia” converted to “aching muscles”).


Source: http://outcomes.cancer.gov/tools/pro-ctcae_fact_sheet.pdf