The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is a standardized set of criteria used to describe the severity of adverse events (AEs) in clinical trials. It is designed to provide a uniform language for describing AEs that can be used across different cancer clinical trials and other research studies. CTCAE is used to assess the safety of treatments and interventions and to compare the safety of different treatments. It is also used to evaluate the effectiveness of interventions and to monitor the progress of patients.
Common Terminology Criteria for Adverse Events
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The Common terminological criteria for adverse events (CTCAE), previously called Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. The CTCAE system is a USA product National Cancer Institute (NCI).
The first iteration was prior to 1998. In 1999, the FDA released version 2.0. CTCAE version 4.0 in 2009 with update to version 4.03 in 2010. Current version 5.0 was released on November 27, 2017. Many clinical trials, now moving beyond oncology, code their observations based on the CTCAE system. It uses a rating scale of 1 to 5. Specific conditions and symptoms may have descriptive values or comments for each level, but the general guideline is:
- 1 – Light
- 2 – Moderate
- 3 – Serious
- 4 – Life risk
- 5 – Death
Grade 1: is defined as mild and asymptomatic symptoms. clinical or diagnostic observations only; Intervention not indicated. Grade 2: it is moderate; Minimal, local or non-invasive intervention was required. Grade 3: Severe or clinically significant symptoms, but not life threatening, but may be disabling or limit self-care in ADL Grade 4: Are life threatening Consequences; Urgent or emergency intervention required Grade 5: Death related to or due to adverse event
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