An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series of three patients (1 male and 2 females) aged between 20 months to 19 years developed depletion of B cells and plasma cells following administration of rituximab and daratumumab [durations of treatments to reactions onsets not stated; not all routes, dosages and outcomes stated]. Subsequently, the 19-year-old woman died due to refractory autoimmune haemolytic anaemia (AIHA).
Patient 1: A 19-year-old woman had pre-B-cell acute lymphoblastic leukemia (B-ALL) with positive minimal residual disease (MRD). She underwent myeloablative haematopoietic stem cell transplantation (HSCT) from a matched unrelated donor (MUD) following conditioning with busulphan, fludarabine, clofarabine and alemtuzumab. Four months (116 days) following the HSCT, and one month after a second...