Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted throughout the oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings. Version 4, released in May 2009, is a major update based on extensive international participation by stakeholders and experts. It is harmonized with MedDRA at the Adverse Event (AE) level, includes revised AE terms and severity indicators to reflect clinical effects identified with current oncology interventions, and is a caBIG vocabulary standard. CTCAE is designed to integrate into information networks for safety data exchange, and is expected to have a significant impact in data management for AE data collection, analysis, and patient outcomes associated with cancer research and care.
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