CTCAE-4

CTCAE-4 is a browsable reference to the CTCAE 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 adverse event.

All AE terms are organized by the System Organ Classes (SOCs) defined by the Medical Dictionary for Regulatory Activities (MedDRA).

The CTCAE has been developed from the earlier vocabulary known as CTC (Common Toxicity Criteria).

Adverse events are common phenomena affecting patients being treated for cancer. With the availability of new agents and the multimodality interventions, it is critical to monitor systematically the AEs that are linked to oncology research.

CTCAE is fundamentally intended to be an agreed upon terminology for the designation, reporting and grading of AEs that occur in oncology research.

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CTCAE serves several purposes
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- To standardize 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 (e.g., eligibility criteria; dose limiting toxicity; maximum tolerated dose; dose modification).

CTC-AE 4 is based on original concept of
Martin E. Donach, M.D., NYU, USA

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REFERENCES
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National Cancer Institute
Common Terminology Criteria
for Adverse Events v4.0
NCI, NIH, DHHS. May 29, 2009
NIH publication # 09-7473

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Karnofsky & ECOG scores
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Am J Clin. Oncol.: Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T., Carbone, P.P.: Toxicity And Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982.The Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair.