Severe Neutropenia/Agranulocytosis is a possible serious adverse event during treatment with the IMP. As agranulocytosis is a sudden and idiosyncratic adverse event, we suggest you to keep your centre supplied with supportive therapy (antibiotic therapy and granulocyte colony stimulating factor) and make sure […]
The DEEP project has received research funding from the European Union under the 7th Framework Programme
Alerts and Recommendations | DEEP Project- Part 2
Definition, confirmation and management of neutropenia during the clinical trial
Definition and confirmation of Neutropenia
Neutropenia is defined as any ANC < 1500/mm3 confirmed in two consecutive measurements and reported as SAE. In case of an abnormal neutrophil count (neutrophil value < 1500/mm3), a second assessment have to be performed within 48 hours from […]
What is the minimum dose to start the IMPs?
The starting dose for Deferiprone is 75 mg/kg/day, and for Deferasirox 20 mg/kg/day of DFX. Furthermore to avoid a disadvantage for patients who have reached higher doses prior to randomization, the starting dose can equal the previous one but only if it is within […]