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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 11 patients conducted between August 2016 and December 2017, 9 patients (3 women and 7 men) aged 49−75 years were described, who developed fatigue, oedema, pleural effusion, ascites, neutropenia, inflammatory lung disease, diarrhoea, anaemia, intracranial haemorrhage, hypertension, proteinuria, nasal bleeding, heart failure or intestinal bleeding during treatment with docetaxel and ramucirumab for advanced recurrent non-small cell lung cancer [routes, dosages and outcomes not stated].
Patient 1: The 67-year-old woman developed fatigue, oedema, pleural effusion and ascites during treatment with docetaxel and ramucirumab for stage IV adenocarcinoma of bone. Initially, she received unspecified immune checkpoint inhibitor, due to which, she developed...
- Yamamoto A, et al. Efforts to Reduce the Risk of Febrile Neutropenia and to Increase the Response Rate to Docetaxel and Ramucirumab Therapy in Patients with Non-Small Cell Lung Cancer. Gan to Kagaku Ryoho 46: 1421-1425, No. 9, Sep 2019. Available from: URL: http://www.pieronline.jp [Japanese; summarised from a translation] - Japan