Safety of Use of Nivestim® to Prevent or Reduce Chemotherapy-induced Febrile Neutropenia in Real Life
18 Years
N/A
Both
Solid Tumors, Hematological Malignancies, Chemotherapy-induced Febrile Neutropenia
Trial Information
Safety of Use of Nivestim® to Prevent or Reduce Chemotherapy-induced Febrile Neutropenia in Real Life
Inclusion Criteria:
- Age ≥ 18 years
- Patients with solid tumors or hematological malignancies
- Patients initiating therapy or chemotherapy which may cause neutropenia (regardless
of the cycle)
- Patients for whom Nivestim® treatment is implemented to reduce or prevent
chemotherapy-induced febrile neutropenia
Exclusion Criteria:
- Patients with a chronic myeloproliferative disorder
- Patients with myelodysplastic syndromes
- Patients who are hypersensitive to any component of Nivestim ®
- Patients who are not receiving chemotherapy
- Patients who have already been included in the study during a previous chemotherapy
line
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with toxic chemotherapeutic agents for solid tumors or hematological malignancies.
Outcome Description:
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.
Outcome Time Frame:
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
Safety Issue:
Yes
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
NEXT
NCT ID:
NCT01574235
Start Date:
October 2011
Completion Date:
May 2014
Related Keywords:
- Solid Tumors
- Hematological Malignancies
- Chemotherapy-induced Febrile Neutropenia
- Neoplasms
- Fever
- Neutropenia
- Hematologic Neoplasms
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