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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective study of 40 patients (administered cetuximab and radiotherapy from April 2013 through March 2016), six patients [including three 64−71 years old men; ages and sexes not stated for three patients] were described, who developed infusion reaction (three patients) and interstitial pneumonia (three patients) following treatment with cetuximab for locally advanced head and neck cancer [outcomes not stated; not all time to reactions onsets not stated].
Patient 1: The patient had locally advanced head and neck cancer. Prior to a radiation therapy, the patient was scheduled to receive cetuximab infusion 400 mg/m2 in the first week and then 250 mg/m2every week. The patient developed grade 2 infusion reaction from the initial dosage of cetuximab. The infusion reaction...
- Yamauchi M, et al. Acute toxicity and outcomes of radiotherapy plus cetuximab in locally advanced head and neck cancer. Japanese Journal of Head and Neck Cancer 44: 310-315, No. 3, Jan 2018. Available from: URL: http://doi.org/10.5981/jjhnc.44.310 [Chinese; summarised from a translation] - JapanGoogle Scholar