An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series from the Lareb and EudraVigilance database, eight patients (1 male and 7 females) within 11−70 years of age [specific ages not stated] were described, who developed membranous glomerulonephritis, focal segmental glomerulosclerosis or nephrotic syndrome during treatment with dasatinib [dosage and route not stated; not all indications, times to reactions onsets and outcomes stated].
Patient 1: A male in the age group 11−20 years was identified from the Lareb database. He had Philadelphia chromosome (Ph)-positive acute lymphoblastic leukaemia and started receiving treatment with dasatinib 60 mg/m2 once a day. Twenty-seven days1following the initiation of dasatinib, he developed nephrotic syndrome including oedema with a 6kg weight gain, proteinuria with a...
- Muller-Hansma AHG, et al. Nephrotic syndrome under treatment with dasatinib: Be aware of a possible adverse drug reaction. Netherlands Journal of Medicine 75: 428-431, No. 10, Dec 2017 - NetherlandsGoogle Scholar