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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 patients with acute lymphoblastic leukaemia (ALL) between 1 July 2000 and 31 July2006 collected from AIEOP-BFM ALL 2000 study, five patients [2 boys; not all sexes stated] aged 3−16 years were described, who developed disseminated aspergillosis during treatment with prednisone, vincristine, daunorubicin, pegaspargase [PEG-asparaginase], dexamethasone, asparaginase [L-asparaginase], etoposide or cyclophosphamide for ALL. Eventually, 4 of the 5 patients died due to complication of aspergillosis [routes, dosages and durations of treatments to reactions onsets not stated; not all outcomes stated].
Patient 1: A 3-year-old boy was diagnosed with ALL and received treatment with prednisone, vincristine, daunorubicin and pegaspargase. Thereafter, he developed...