DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs

Inclusion Criteria:

1. Signed informed consent form;
2. Histologically verified diagnosis;
3. Age between 18 and 80 years;
4. If the patient had previously received chemotherapy for these indications, then itshould be completed at least 30 days before the first administration of the studydrug;
5. ECOG performance 0-2;
6. Haematology:

• ANC ≥ 1,5 х 10(9) /L;
• Platelets ≥ 100 х 10(9) /L;
• Hemoglobin ≥ 90 g/L;

7. Biochemistry:

• Creatinine ≤ 1,5 ULN;
• Total bilirubin ≤ 1,5 ULN;
• AST/ALT ≤ 2,5 ULN;
• Alkaline phosphatase ≤ 5 ULN;

8. Life expectancy of at least 6 months from the date of the first drug administration inthe study;
9. Ability of the patient to comply with the Protocol requirements.

Exclusion Criteria:

1. Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / ortheir constituent excipients: pegylated drugs, protein recombinant drugs;
2. Systemic use of antibiotics less than 72 hours before the first drug administration inthe study;
3. Concurrent or less than 30 days before the start of the study, radiation therapy (withthe exception of point radiation therapy for bone metastases); study;
4. Concurrent participation in clinical trials, participation in clinical trials withinthe previous 30 days, previous participation in this study;
5. Surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking anyexperimental medications less than 30 days before enrollment in this study;
6. History of bone marrow or hematopoietic stem cell transplantation;
7. Presence of acute or active chronic infections;
8. Other diseases (with the exception of the main one) that could affect the assessmentof the severity of the symptoms of the underlying disease: that may mask, enhance,change the symptoms of the underlying disease or cause clinical manifestations andchanges in the data of laboratory and instrumental research methods;
9. Inability to administer the drug by intravenous infusion or subcutaneous injection.