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The purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with Nivestim™ in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hospitalisation due to febrile neutropenia and/or infection | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characterisation of patients being treated with Nivestim™ | Characterisation of patient based on:
| 6 months |
| Treatment with Nivestim™ as part of daily routine |
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Inclusion Criteria:
Exclusion Criteria:
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Children and adult patients with a solid tumour or a malignant haematological tumour
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facharzt für Innere Medizin, Onkologie, Hämatologie | Ahaus | 48683 | Germany | |||
| Studienzentrum Hämatologie/Onkologie/Diabetologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27743353 | Derived | 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. | |
| 24237790 |
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|
| 6 months |
| Description of the efficacy of treatment with Nivestim™ | Description of the efficacy of treatment with Nivestim(TM) which includes the following parameters:
| 6 months |
| Detailed description of tolerability and safety |
| 6 months |
| Description of the characteristics of the participating physicians | Socio-demographic data (age, gender, field of specialisation, structure of practice, title) | During the study initiation visit |
| Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor) | Criteria for selecting Nivestim™ | During the study initiation visit |
| Aschaffenburg |
| 63739 |
| Germany |
| Facharzt für Innere Medizin Hämatologie / Onkologie | Bad Säckingen | 79713 | Germany |
| MediOnko-Institut GbR | Berlin | 10367 | Germany |
| Onkoplan GmbH/Onkologische Schwerpunkpraxis | Berlin | 13055 | Germany |
| FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie | Chemnitz | 09117 | Germany |
| MVZ Delitzsch GmbH | Delitzsch | 04509 | Germany |
| Gesellschaft für onkologische Studien Dortmund mbH | Dortmund | 44263 | Germany |
| Gemeinschaftspraxis | Dresden | 01307 | Germany |
| Gemeinschaftspraxis Haematologie/Medizin Onkologie | Düsseldorf | 40479 | Germany |
| Gemeinschaftspraxis | Eisenach | 99817 | Germany |
| Krankenhaus Nordwest GmbH Institut für klinische Forschung | Frankfurt am Main | 60486 | Germany |
| Internist - Hämatologe - Onkologe | Garbsen | 30827 | Germany |
| Onkodok GmbH | Gütersloh | 33332 | Germany |
| Fachärztin für Allgemeinmedizin | Hamburg | 20095 | Germany |
| Facharzt für innere Medizin | Hamburg | 22765 | Germany |
| Internist - Hämatologe - Onkologe | Hanover | 30625 | Germany |
| ODZ-Petersen GmbH | Heidenheim | 89518 | Germany |
| DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG | Herne | 44623 | Germany |
| ZAGO | Krefeld | 47805 | Germany |
| FA f. Frauenheilkunde und Geburtshilfe | Leipzig | 04107 | Germany |
| Pneumologisch/onkologisch/internistisches Studienzentrum | Leipzig | 04357 | Germany |
| Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin | Lippstadt | 59555 | Germany |
| Praxis für Innere Medizin, Hämatologie und Onkologie | Mainz | 55131 | Germany |
| Johannes Esling Klinikum Minden | Minden | 32429 | Germany |
| OnkoLog Moers GbR | Moers | 47441 | Germany |
| Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen | München | 80638 | Germany |
| Forschungs- und Studiengesellschaft HOPE München GmbH | München | 81245 | Germany |
| Münster | 48149 | Germany |
| FÄ für Innere Medizin Hämatologie/Internistische Onkologie | Neustadt A. Rbge | 31535 | Germany |
| Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin | Neustadt/Sachsen | 01844 | Germany |
| MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe | Nordhausen | 99734 | Germany |
| Martha-Maria Krankenhaus gGmbH MVZ Onkologie | Nuremberg | 90491 | Germany |
| Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie | Oelde | 59302 | Germany |
| Onkologische Praxis Oldenburg/ Delmenhorst | Oldenburg | 26121 | Germany |
| Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis | Olpe | 57462 | Germany |
| Osnabrück | 49076 | Germany |
| Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie | Remscheid | 42859 | Germany |
| Frauenärzte -Naturheilverfahren- | Rodgau | 63110 | Germany |
| Facharzt für Fraueneheilkunde und Geburtshilfe Gynäkologische Onkologie | Scheibenberg | 09481 | Germany |
| Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH | Siegburg | 53721 | Germany |
| Medizinisches Versorgungszentrum GbR | Soest-Paradiese | 59494 | Germany |
| g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed. | Stralsund | 18435 | Germany |
| Stuttgart | 70190 | Germany |
| Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie | Velbert | 42551 | Germany |
| Gesellschaft zur Förderung von Wissenschaft und Qualitätssicherung in der ambulanten Onkologie (GFWQ) | Wiesbaden | 65191 | Germany |
| FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH | Witten | 58452 | Germany |
| FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin | Zittau | 02763 | Germany |
| 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. |