International classification of diseases
The International Classification of Diseases (ICD) is the international standard diagnostic classification system for all general epidemiological and clinical uses as well as many health management purposes. ICD-10 is available in the six official languages of the World Health Organization (Arabic, Chinese, English, French, Russian and Spanish) as well as in 36 other languages.
Common terminology criteria for adverse events
The National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) developed the original Common Toxicity Criteria (CTC) in 1982 in an effort to provide a standard language for reporting adverse events occurring in cancer clinical trials sponsored by the NCI. The CTC were widely adopted internationally and as new agents were introduced and new adverse events identified, many groups added supplemental criteria. This independent revision of the CTC resulted in non-standard adverse-event nomenclature and inconsistent definitions for severity. In keeping with international harmonisation efforts, a CTC Review Committee including representatives of the pharmaceutical industry, the Food and Drug Administration (FDA), the Committee for Proprietary Medicinal Products (CPMP), and major clinical trials groups in the United States, Canada, Europe, and Japan was convened. The objective of the committee was to improve accuracy, precision and completeness of the CTC and to standardise adverse-event reporting. As part of its commitment to the International Conference on Harmonisation (ICH), the United States FDA agreed to adopt an internationally agreed upon International Medical Terminology (IMT) system based on the Medicines Control Agency's Medical Dictionary for Drug Regulatory Reporting (MedDRA), for reporting medical information from clinical trials. To facilitate data transfer, the NCI has mapped adverse-event names from CTC version 2.0 to preferred terms in the IMT.
CTCAE v4.03 information is in the Public Domain and is now available for use by any non-CTEP site. The terminology provided for the grading of skin toxicity on this website follows the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 (published May 28, 2009 and reviewed June 14, 2010.1). An independent tool for the scoring of acneiform skin eruptions is also available.2
1National Cancer Institute Cancer Therapy Evaluation Program (CTEP). Common Toxicity Criteria for Adverse Events v4.03 (CTCAE) 2009.
2Wollenberg A et al. Exp Dermatol 2008; 17: 790-792.