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The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curative or prophylactic Nivestim® treatment for FN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivestim® | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy. | The safety will be assessed by the record of all treatment emergent adverse events and all data about hospitalization due to any febrile neutropenia or infection. | Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of treatment with Nivestim® | Assess the efficacy of the treatment with Nivestim® by studying occurrence of febrile neutropenia, infection and the impact of these events on the chemotherapy treatment (cycle postponement, dose reduction) | Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving chemotherapy and treated with Nivestim® to prevent or reduce chemotherapy-induced febrile neutropenia.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Louis Pasteur | Colmar | Alsace | France | |||
| Hopital Jean Monnet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24237790 | Derived | 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. |
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| Characteristics of the patients treated with Nivestim® in real-life practice | Describe the characteristics of the patients treated with Nivestim® in real-life practice, | At Visit 1 |
| Methods of treatment with Nivestim® | Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice. | Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months |
| Profiles of the physicians participating in the study | Describe the profiles of the physicians participating in the study | At visit 1 |
| General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF) | Assess the general practice of these physicians with regard to prescription of G-CSF | At visit 1 |
| Épinal |
| Alsace |
| France |
| CH Emile Muller | Mulhouse | Alsace | France |
| CAC Paul Strauss | Strasbourg | Alsace | France |
| Chu Hopital Civil | Strasbourg | Alsace | France |
| STE ANNE | Strasbourg | Alsace | France |
| MEDIPOLE | Aix-les-Bains | Auvergne-Rhône-Alpes | France |
| CHRA | Annecy | Auvergne-Rhône-Alpes | France |
| Clinique CONVERT | Bourg-en-Bresse | Auvergne-Rhône-Alpes | France |
| Ch Chambery | Chambéry | Auvergne-Rhône-Alpes | France |
| Chu Grenoble | Grenoble | Auvergne-Rhône-Alpes | France |
| Ch Valence | Valence | Auvergne-Rhône-Alpes | France |
| Polyclinique Cesson | Cesson | Basse Normandie | France |
| Chu Rennes | Rennes | Basse Normandie | France |
| CHU SUD | Rennes | Basse Normandie | France |
| Clinique St Laurent | Rennes | Basse Normandie | France |
| Chp St Greg | Saint-Grégoire | Basse Normandie | France |
| Ch St Malo | St-Malo | Basse Normandie | France |
| CHG William MOREY | Chalon S/s | Bourgogne-Franche-Comté | France |
| CHU du BOCAGE | Dijon | Bourgogne-Franche-Comté | France |
| Clinique St Faron | Meaux | Champagne | France |
| Cac Jean Godinot | Reims | Champagne | France |
| Hopital St Quentin | Saint-Quentin | Champagne | France |
| Hopital Troyes | Troyes | Champagne | France |
| CHG Dieppe | Dieppe | Haute Normandie | France |
| Clinique Pasteur | Évreux | Haute Normandie | France |
| CH Jacques Monod | Montivilliers | Haute Normandie | France |
| Centre frederic joliot curie | Rouen | Haute Normandie | France |
| CHG | Alès | Languedoc | France |
| CHG | Béziers | Languedoc | France |
| CHG | Carcassonne | Languedoc | France |
| Chu St Eloi | Montpellier | Languedoc | France |
| Clinique Beausoleil | Montpellier | Languedoc | France |
| CHU Caremeau | Nîmes | Languedoc | France |
| Chg St Jean | Perpignan | Languedoc | France |
| Ch Du Pays D'Aix | Aix-en-Provence | Marseille | France |
| Clinique Rambot | Aix-en-Provence | Marseille | France |
| Ch Duffaut | Avignon | Marseille | France |
| Chp Clairval | Marseille | Marseille | France |
| Chu Timone | Marseille | Marseille | France |
| Fondation Saint Joseph | Marseille | Marseille | France |
| Hopital A.Pare | Marseille | Marseille | France |
| IPC | Marseille | Marseille | France |
| Chr Brive | Brivé | Massif Central | France |
| Chu Estaing | Clermont | Massif Central | France |
| Chu Gabriel Montpied | Clermont | Massif Central | France |
| Pole Sante Republique | Clermont | Massif Central | France |
| Clinique Vitalia Desertines | Montluçon | Massif Central | France |
| CHR | Roanne | Massif Central | France |
| Icl St Etienne | Saint-Etienne | Massif Central | France |
| CHG Cahors | Cahors | Midi Pyrennees | France |
| CHG St Gaudens | Saint-Gaudens | Midi Pyrennees | France |
| Clinique de l'Ormeau | Tarbes | Midi Pyrennees | France |
| CHU Purpan | Toulouse | Midi Pyrennees | France |
| Clinique Pasteur | Toulouse | Midi Pyrennees | France |
| Inst. Claudius Regaud | Toulouse | Midi Pyrennees | France |
| Clinique des Bonnettes | Arras | Nord | France |
| CH Boulogne-sur-Mer | Boulogne | Nord | France |
| Centre Oscar Lambret | Lille | Nord | France |
| Clinique des Dentellieres | Valenciennes | Nord | France |
| CH de Draguignan | Draguignan | Paca | France |
| CHI de Fréjus | Fréjus | Paca | France |
| Chi Frejus - St Raphael | Fréjus | Paca | France |
| CHICAS | Gap | Paca | France |
| Clinique Ste Marguerite | Hyères | Paca | France |
| Clinique du Cap d'Or | La Seyne-sur-Mer | Paca | France |
| Clinique Belvédère | Nice | Paca | France |
| CH Sainte Musse | Toulon | Paca | France |
| H.I.A Saint Anne | Toulon | Paca | France |
| Victor Dubos | Argenteuil | Paris Nord | France |
| Clinique Ste Marie | Osny | Paris Nord | France |
| Saint Antoine | Paris | Paris Nord | France |
| Saint Louis | Paris | Paris Nord | France |
| TENON | Paris | Paris Nord | France |
| Hpt Rene Dubos | Pontoise | Paris Nord | France |
| Clinique Porte St Cloud | Boulogne | Paris Ouest | France |
| BEAUJON | Clichy | Paris Ouest | France |
| Hopital Mignot | Le Chesnay | Paris Ouest | France |
| Hopital Franco Britannique | Levallois-Perret | Paris Ouest | France |
| Hopital Des Courses | Maisons-Laffitte | Paris Ouest | France |
| HARTMANN | Neuilly/seine | Paris Ouest | France |
| Centre Rene Huguenin | Saint-Cloud | Paris Ouest | France |
| Hopital Foch | Suresnes | Paris Ouest | France |
| Ico Angers | Angers | Pays de la Loire Region | France |
| Ch Cholet | Cholet | Pays de la Loire Region | France |
| Ch Le Mans | Le Mans | Pays de la Loire Region | France |
| Victor Hugo | Le Mans | Pays de la Loire Region | France |
| ID | Term |
|---|---|
| D064146 | Chemotherapy-Induced Febrile Neutropenia |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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