Femme et Homme
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Extrait
• To allow long term bosutinib treatment in subjects with chronic or advanced phases Ph+ CML who received bosutinib in a previous Pfizer sponsored CML study (ie, studies B1871006 and B1871008) and who have the potential, as judged by the investigator, to derive clinical benefit from continued treatment with bosutinib; • To collect long term safety and efficacy data for bosutinib; • To assess the duration of clinical benefit for Ph+ CML subjects treated with bosutinib; • To fulfill the European Medicines Agency (EMA) post approval requirement for the collection and analysis of safety data about diarrhea incidence after switch from clinical study to commercial bosutinib formulation.
Critère d'inclusion
- Chronic Myeloid Leukemia (CML)