- 68 Downloads
An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective analysis of 32 patients (recruited between 2011 and 2016), four patients (2 men and 2 women) aged 52−61 years were described, who developed intracranial haemorrhage, abdominal pain, diarrhoea, shock, hepatic-renal syndrome or fever during treatment with pegaspargase, dexamethasone, daunorubicin or prednisone. Eventually, the patients died [immediate causes of death not stated; not all outcomes stated].
Patient 1: A 58-year-old man developed hepatotoxicity and intracranial haemorrhage during treatment with pegaspargase [pegylated asparaginase], dexamethasone and daunorubicin: The man, who had acute lymphoblastic leukaemia received pre-treatment with dexamethasone 10 mg/m2for 5 days continued on day 1−day 7 and day 15−day 21 followed by induction with...
- Helbig G, et al. Safety profile of a single pegylated asparaginase (PEG-ASP) dose in remission induction for acute lymphoblastic leukemia (ALL). Neoplasma 65: 993-997, No. 6, 2018. Available from: URL: http://doi.org/10.4149/neo_2018_180214N121 - Poland