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Table 1 Information included on case report forms for baseline and follow-up visits

From: Study design: two long-term observational studies of the biosimilar filgrastim Nivestim™ (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia

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.  
  1. Abbreviations: ANC absolute neutrophil count, HIV human immunodeficiency virus, COPD chronic obstructive pulmonary disease, CRP C-reactive protein, AEs adverse events.