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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 conducted from December 2016 to May 2018 involving 15 patients, 12 patients (8 males and 4 females) aged 11-55 years were described, who developed perianal abscess, pneumothorax, hand-foot syndrome, lipotimia, diarrhoea, hypertension, thrombocytopenia, nausea, hyperbilirubinaemia or anaemia following treatment with pazopanib for metastatic osteosarcoma. Two of the 12 patients received pazopanib therapy in an off label manner [not all dosages, duration of therapy to reactions onsets and outcomes stated].
Case 1: A 20-year-old man, who had metasatatic osteosarcoma with lung as a site of metastases, started receiving treatment with oral pazopanib 800 mg/day in May 2017. Three weeks later, he was diagnosed with pneumothorax, and pazopanib was discontinued. Consequently,...