- 10 Downloads
An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a single center retrospective study involving 5773 patients, six patients aged 35−69 years (3 men and 3 women) were described, who developed central nervous system post-transplantation lymphoproliferative disorder (CNS PTLD) following treatment with mycophenolate mofetil. Additionally, out of the six patients, one patient developed micro thrombi within arterioles in kidney secondary to ciclosporin and one patient developed unspecified tacrolimus toxicity [not all routes, dosages, time to reactions onsets and outcomes stated].
Patient 1: The 62-years-old man, who had systemic lupus erythematosus, deep vein thrombosis, hypertension and osteoporosis, presented with cervical, superior mediastinal, inguinal lymphadenopathy, weight loss and fever. He had undergone kidney transplant...