Skip to main content

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.