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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 31-year-old man developed Pseudomonas aeruginosa pneumonia, Mycobacterium avium infection, BK virus infection, disseminated cryptococcal infection, acute kidney injury (AKI) and thrombotic microangiopathy during treatment with cyclophosphamide, vincristine, doxorubicin [adriamycin], dexamethasone, inotuzumab-ozogamicin [inotuzumab], fludarabine, mephalan, antithymocyte globulin, tacrolimus, mycophenolate mofetil, budesonide, amphotericin-B-liposomal, cotrimoxazole [trimethoprim-sulfamethoxazole], valaciclovir and spironolactone [routes not stated; not all dosages stated].
The man was diagnosed with primary B-lineage acute lymphoblastic leukaemia in February 2013. Subsequently, he was started on chemotherapy. He achieved complete remission following treatment with...