Safety assessment of Granulocyte Colony Stimulating Factor:ior LeukoCIM in oncohematologic patients.Phase IV study.
Phase 4
- Conditions
- eutropenia secondary to Chemotherapy and/or Radiotherapy in oncohematologic patients .
- Registration Number
- RPCEC00000083
- Lead Sponsor
- Center of Molecular Immunology(CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1.Patients who met the diagnostic criteria and/or condition of use. 2.Patients with cytologic diagnosis and/or histologically confirmed cancer of any location that are receiving QT and/or RT. 3.Patients of all ages and both sexes.
Exclusion Criteria
1.Patients with known hypersensitivity to products derived from cells of E.Coli or other preparations of rG-CSF. 2.Patients pregnant or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AE) with a causal relationship (IOR LeukoCIM) likely or very likely, measurement time 21 days.
- Secondary Outcome Measures
Name Time Method Recovery of the Absolute Neutrophil Count figures to = 1.5 x 109/L,was assessed using the dichotomous answer yes/no, 21 days measurement time. Time of rercovery the Absolute Neutrophil Count figures to = 1.5 x 109/L, will be assessed on days 21 days measurement time. Biochemical parameters, the values recorded by the units set for each measurement time 21 days. Occurrence of any adverse event was evaluated by yes/no, measurement time: 21 days. Duration of adverse events was assessed in hours and days, measuring time: 21 days. Intensity of adverse events, Light, Moderate, Severe, Very Severe, measurement time: 21 days Result, recovered, improved, or persisted Secuelas, measurement time: 21 days Attitude to treatment, no change, modification of dose or temporary interruption final measurement time: 21 days Causal relationship, very likely, likely, possible, remote, measurement time:21 days