Who is the contact at Chugai Pharma UK?
Mr David Eves: Tel. +44 (0)7774415571, email d.eves@chugai-pharm.co.uk [ Back To Questions ] Q.27 At the end of their first session of Cisplatin and Doxorubicin, the patient was still suffering from nausea and vomiting and so was kept in hospital overnight and was discharged the following day. Should this be reported as a SAE? This is defined as a SAE as it required hospitalization or prolongation of an existing hospitalization, however the EURAMOS 1 protocol (section 13.4) has defined some exceptions for SAE reporting: Hospitalisation for chemotherapy is not reported as an SAE. In addition expected side effects of chemotherapy, which are listed in the product information, will not be reported on an SAE form for the purposes of this clinical trial unless in the opinion of the investigator they unexpectedly prolonged the hospitalization or required intensive care therapy.
