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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, five men aged 50−69 years were described, who developed hypothyroidism, hypertension, hand-foot syndrome, diarrhoea, fatigue, anorexia, proteinuria or weight loss during treatment with lenvatinib for unresectable anaplastic thyroid cancer [routes not stated; not all time to reactions onsets and outcomes stated].
Case 1: A 58-year-old man, who was diagnosed with de novo stage IVB unresectable anaplastic thyroid cancer, started receiving treatment with lenvatinib 24mg once a day. Two weeks following the initiation of lenvatinib, he developed grade 2 hypothyroidism, which was managed with levothyroxine sodium. Four weeks following lenvatinib initiation, he developed grade 1 hand-foot syndrome and grade 2 hypertension. He received amlodipine and...