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Brief Title: Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
Official Title: International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.
Study ID: NCT01459653
Brief Summary: This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sandoz Investigational Site, Innsbruck, , Austria
Sandoz Investigational Site, Kufstein, , Austria
Sandoz Investigational Site, Leoben, , Austria
Sandoz Investigational Site, Deurne, , Belgium
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Sandoz Investigational Site, Agen, , France
Sandoz Investigational Site, Arras, , France
Sandoz Investigational Site, Avignon, , France
Sandoz Investigational Site, Bayonne, , France
Sandoz Investigational Site, Beauvais Cedex, , France
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Sandoz Investigational Site, Bois Guillaume Cedex, , France
Sandoz Investigational Site, Bordeaux Cedex, , France
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Sandoz Investigational Site, Compiègne, , France
Sandoz Investigational Site, Gap Cedex, , France
Sandoz Investigational Site, Grenoble, , France
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Sandoz Investigational Site, Lille Cedex, , France
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Sandoz Investigational Site, Paris Cedex 12, , France
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Sandoz Investigational Site, Perpignan, , France
Sandoz Investigational Site, Pierre Bénite, , France
Sandoz Investigational Site, Poitiers, , France
Sandoz Investigational Site, Reims Cedex, , France
Sandoz Investigational Site, Sainte-Foy-lès-Lyon, , France
Sandoz Investigational Site, Strasbourg Cedex, , France
Sandoz Investigational Site, Berlin, , Germany
Sandoz Investigational Site, Chemnitz, , Germany
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Sandoz Investigational Site, Cottingham, , United Kingdom
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Sandoz Investigational Site, Scunthorpe, , United Kingdom
Name: Sandoz GmBH
Affiliation: Sandoz GmbH
Role: STUDY_CHAIR