An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series two patients were described, a 19-year-old girl who developed osteonecrosis of femoral head (ONFH) during treatment with prednisone and dexamethasone, and a 20-year-old man who developed ONFH during treatment with dexamethasone for acute lymphoblastic leukaemia [time to reactions onset not stated].
Patient 1: The 19-year-old girl, who was diagnosed with acute lymphoblastic leukaemia (ALL) in November 2011, started receiving treatment following the Spanish PETHEMA protocol in the Intermediate Risk group, which involved administration of oral prednisone 60 mg/m2 daily over 28 days in the first induction phase and oral dexamethasone 10 mg/m2daily over 21 days in re-induction. She was receiving maintenance therapy with mercaptopurine and methotrexate. After...
- de Rojas T, et al. Outcome of childhood leukaemia survivors and necrosis of the femoral head treated with autologous mesenchymal stem cells. Clinical and Translational Oncology 20: 584-590, No. 5, May 2018. Available from: URL: http://doi.org/10.1007/s12094-017-1752-9 - Spain