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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 involving 10 infants (study conducted between 2007 and 2017), three infants (one female infant and two male infants) aged 8 months−2 years and 8 months were described, who developed adrenal insufficiency during treatment with busulfan, cyclophosphamide, cytarabine, dexamethasone, etoposide, fluconazole, hydrocortisone, melphalan, methotrexate or prednisone for acute myeloblastic leukaemia or acute lymphoblastic leukaemia [not all routes and dosages stated; duration of treatments to reaction onset not stated].
Patient 1: A boy was diagnosed with acute myeloblastic leukaemia at birth. He received two courses of chemotherapy with busulfan, fludarabine and melphalan. He had graft-versus-host disease (GVHD) and underwent haematopoietic stem cell transplantation (HSCT),...