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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 case report, a 64-year-old man and a 62-year-old man developed bacterial translocation and its complications following treatment with cisplatin, docetaxel and fluorouracil for right hypopharyngeal squamous cell carcinoma [routes and dosages not stated].
Case 1: The 64-year-old man, who had right hypo-pharyngeal squamous cell carcinoma, was hospitalised and received one course of induction chemotherapy with cisplatin, docetaxel and fluorouracil [5-FU]. He then underwent bilateral neck dissection, free jejunal flap and total laryngopharyngectomy. One week after the surgery, monitor jejunum was excised, and three days after the surgery gastric PEG tube intake was initiated. However, two days after the onset of PEG tube, he developed increased WBC count, CRP spike, chilling and...