Baseline visit | Follow-up visits |
---|---|
• Informed consent | • ANC-nadir, ANC-value |
• Criteria for inclusion and exclusion | • AEs (hospitalisation, clinically relevant) |
• General information relating to the patient being | • Vital parameters |
• treated (status, demographic) | • Blood tests |
• Vital parameters | • Description of chemotherapy including dose modifications |
• Medical and surgical anamnesis (FN, recurrent infections, HIV, COPD, cardiovascular diseases, renal or hepatic insufficiency) | • Prescription of Nivestim™ |
• Preceding treatments (chemotherapy, radiotherapy and/or surgery) | • Withdrawal before end of study, including reasons and date |
• Information relating to pathology of malignant haemopathies (Hodgkin’s, non-Hodgkin’s, TNM, stem-cell transformations) | • Concomitant therapies. |
• Information relating to the pathology of solid tumours (localisation, TNM) | |
• Laboratory (haemoglobin, thrombocytes, leukocytes, neutrophil, CRP, CD34+ cell count) | |
• Infections (type, localisation, additional factors [hypotension, dermatitis, erysipelas, sepsis]) | |
• Description of chemotherapy (aims, schedule, duration, cycles, active principle) | |
• Prescription of Nivestim (primary/secondary prophylaxis, dosage, duration, antibiotic, time-frame. |