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A Post-marketing Surveillance Study on Erbitux in Combination With Platinum-based Chemotherapy in Metastatic/Recurrent Squamous Cell Cancer of the Head and Neck

Merck KGaA, Darmstadt, Germany · 2009
ClinicalTrials.gov · Datasets · License: Public Domain · 2009
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carcinomahead-and-neck-neoplasmsneoplasms
This is a prospective post-marketing surveillance (PMS) study to collect safety information from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN) treated with Erbitux as final evaluable cases. This PMS study is requested by the Korean Regulatory Authorities. After approval of new indication in Korea, there is a requirement to investigate more than 600 subjects during six years, to continue monitoring and provide further information about safety and toxicity in clinical practice.
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