D70.1
Conditions
Interventions
Group 1: Filgrastim HEXAL is used following the instructions in Ch. 4.2 of the summary of product characteristics. The study documents routinely collected clinical data and laboratory values over six
Sponsors
Hexal AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients treated with cytotoxic CT for malignant disease and receiving Filgrastim HEXAL according to SmPC; treatment with Filgrastim HEXAL anticipated over two to six CT cycles; written informed consent of patients available covering pro- and retrospective pseudonymised documentation, transmission and analysis of data as well as inspection of data during monitoring.
Exclusion criteria
Exclusion criteria: Therapy with another filgrastim during the current CT line; contraindications or specific risks of Filgrastim therapy; earlier participation in the study; pregnancy or breast-feeding; anticipated lack of compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness of Filgrastim HEXAL: incidence of febrile neutropenia, duration and severity of leucopenia and neutropenia, relative dose intensity of chemotherapy achieved. Safety Profile of Filgrastim HEXAL: ADRs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibiotics: incidence and intention of antibiotics therapy, incidence of antibiotics resistance. Model of Jenkins for predicing risk of (febrile) neutropenia: baseline neutrophils and lymphocytes. | — |
Countries
Germany
Contacts
Public ContactDietmar Bulenda
Hexal AG
Outcome results
None listed