Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
386 participants
OBSERVATIONAL
2011-06-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Declaration of informed consent signed by patient or legal guardian
* Patients with a solid tumour or with a malignant haematological tumour
* Patients for whom cytotoxic chemotherapy is planned, irrespective of cycle
* Patients who are due to undergo, or who should undergo, (primary or secondary) prophylactic treatment using Nivestim™, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced febrile neutropenia (FN).
Exclusion Criteria
* Patients who are hypersensitive to the active substance or to one of the excipients of Nivestim™
* Patients not undergoing chemotherapy
* Patients being treated curatively with Granulocyte-Colony Stimulating Factor (G-CSF)
ALL
No
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Locations
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Facharzt für Innere Medizin, Onkologie, Hämatologie
Ahaus, , Germany
Studienzentrum Hämatologie/Onkologie/Diabetologie
Aschaffenburg, , Germany
Facharzt für Innere Medizin Hämatologie / Onkologie
Bad Säckingen, , Germany
MediOnko-Institut GbR
Berlin, , Germany
Onkoplan GmbH/Onkologische Schwerpunkpraxis
Berlin, , Germany
FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie
Chemnitz, , Germany
MVZ Delitzsch GmbH
Delitzsch, , Germany
Gesellschaft für onkologische Studien Dortmund mbH
Dortmund, , Germany
Gemeinschaftspraxis
Dresden, , Germany
Gemeinschaftspraxis Haematologie/Medizin Onkologie
Düsseldorf, , Germany
Gemeinschaftspraxis
Eisenach, , Germany
Krankenhaus Nordwest GmbH Institut für klinische Forschung
Frankfurt am Main, , Germany
Internist - Hämatologe - Onkologe
Garbsen, , Germany
Onkodok GmbH
Gütersloh, , Germany
Fachärztin für Allgemeinmedizin
Hamburg, , Germany
Facharzt für innere Medizin
Hamburg, , Germany
Internist - Hämatologe - Onkologe
Hanover, , Germany
ODZ-Petersen GmbH
Heidenheim, , Germany
DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
Herne, , Germany
ZAGO
Krefeld, , Germany
FA f. Frauenheilkunde und Geburtshilfe
Leipzig, , Germany
Pneumologisch/onkologisch/internistisches Studienzentrum
Leipzig, , Germany
Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin
Lippstadt, , Germany
Praxis für Innere Medizin, Hämatologie und Onkologie
Mainz, , Germany
Johannes Esling Klinikum Minden
Minden, , Germany
OnkoLog Moers GbR
Moers, , Germany
Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen
München, , Germany
Forschungs- und Studiengesellschaft HOPE München GmbH
München, , Germany
Münster, , Germany
FÄ für Innere Medizin Hämatologie/Internistische Onkologie
Neustadt A. Rbge, , Germany
Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin
Neustadt/Sachsen, , Germany
MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe
Nordhausen, , Germany
Martha-Maria Krankenhaus gGmbH MVZ Onkologie
Nuremberg, , Germany
Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie
Oelde, , Germany
Onkologische Praxis Oldenburg/ Delmenhorst
Oldenburg, , Germany
Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis
Olpe, , Germany
Osnabrück, , Germany
Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie
Remscheid, , Germany
Frauenärzte -Naturheilverfahren-
Rodgau, , Germany
Facharzt für Fraueneheilkunde und Geburtshilfe Gynäkologische Onkologie
Scheibenberg, , Germany
Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH
Siegburg, , Germany
Medizinisches Versorgungszentrum GbR
Soest-Paradiese, , Germany
g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed.
Stralsund, , Germany
Stuttgart, , Germany
Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie
Velbert, , Germany
Gesellschaft zur Förderung von Wissenschaft und Qualitätssicherung in der ambulanten Onkologie (GFWQ)
Wiesbaden, , Germany
FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH
Witten, , Germany
FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin
Zittau, , Germany
Countries
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References
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Fruehauf S, Otremba B, Stotzer O, Rudolph C. Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study. Adv Ther. 2016 Nov;33(11):1983-2000. doi: 10.1007/s12325-016-0419-1. Epub 2016 Oct 14.
Kamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C. Study design: two long-term observational studies of the biosimilar filgrastim Nivestim (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia. BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547.
Other Identifiers
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VENICE
Identifier Type: -
Identifier Source: org_study_id
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