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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 study, 7 patients (3 women and 4 men) aged between 61-85 years, were described, who developed fatigue, hypertension, hand-foot skin reaction, lactate dehydrogenase elevation, anorexia, fever or renal dysfunction 1 during treatment with regorafenib for metastatic cancer [routes, duration of treatment to reactions onsets and outcomes not stated].
Case 1: A 61-year-old woman developed fatigue during treatment with regorafenib for metastatic lymph nodes and lung cancer. The woman had a history of hepatitis-B, rectum cancer and peripheral neuropathy. She had previously received four standard chemotherapies including folinic acid, fluorouracil and oxaliplatin [FOLFOX], folinic acid, fluorouracil and irinotecan [FOLFIRI] with bevacizumab and cetuximab for rectum cancer. She had a...
- Nakashima M, et al. Seven cases of metastatic colorectal cancer treated with dose-reduced and duration-reduced regorafenib treatment. [Japanese]. Gan to Kagaku Ryoho 45: 1673-1676, No. 11, Nov 2018 [Japanese; summarised from atranslation] - JapanGoogle Scholar