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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 man in his mid 70s' [exact age at reactions onset not stated] developed renal insufficiency and acute amoebic encephalitis during treatment with mycophenolate, prednisone and tacrolimus following an allogeneic peripheral blood haematopoietic stem-cell transplant [HSCT; not all dosages stated, routes not stated].
The man had a history of hyperlipidaemia, hypertension, stent placement and coronary artery disease, which required angioplasty. Following treatment with fludarabine, busulfan and antithymocyte globulin [anti-thymocyte globulin], he had received an allogeneic peripheral blood HSCT for acute myelogenous leukaemia. He started receiving prednisone and tacrolimus for prevention of graft-versus-host disease (GVHD) after transplantation. Also, he started receiving...
- Molina A, et al. Acute amebic encephalitis in an allogeneic hematopoietic stem-cell transplant recipient: Still an overlooked diagnosis. Infectious Diseases in Clinical Practice 27: 188-190, No. 4, Jul 2019. Available from: URL: http://doi.org/10.1097/IPC.0000000000000744 - USA