An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 64-year-old man developed disseminated Bacillus cereus bacteraemia with CNS involvement following treatment with cytarabine, idarubicin, lenalidomide and corticosteroid [specific drug not stated]. He also developed neutropenia secondary to treatment with cytarabine, idarubicin and lenalidomide. Additionally, he developed cutaneous rash, face oedema and finger oedema secondary to treatment with cytarabine [routes not stated; not all dosages stated].
The man, who had acute myeloid leukaemia, started receiving chemotherapy treatment with lenalidomide 15 mg/day on days 1−21, cytarabine 200 mg/m2 on days 1–7 and idarubicin 12 mg/m2on days 1−3. After first cycle of chemotherapy, he developed an episode of agranulocytosis with fever, left frontal headache, and left nasal...