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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A case report described three boys aged 9−14 years were described, who developed secondary chondroblastic or osteoblastic osteosarcoma following treatment with cyclophosphamide, etoposide or ifosfamide for medulloblastoma, germ cell tumour or anaplastic astrocytoma [routes not stated; not all dosages stated]. Out of these patients, the 9-year-old boy died due to disseminated metastatic disease, including the worsening of lung metastasis.
Case 1: An 11-year-old boy presented with pain in the left thigh persisting more than two months. He had developed medulloblastoma in the cerebellar vermis at 4 years of age. The treatment for the medulloblastoma consisted of tumour resection followed by radiotherapy and high-dose intensive chemotherapy. He received chemotherapy with...