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Table 3 Evaluation of AEs in NEXT and VENICE

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

All AEs will be evaluated according to:
Clinical relevance
Degree of seriousness (if deemed serious, a description of the outcome of each AE, e.g. death, life-threatening, hospitalisation, will be given)
Intensity (mild, moderate, severe)
Outcome (restoration, persistent damage, etc.)
Relationship to G-CSF therapy (none, possible, probable)
Occurrence of AEs relative to the first administration of Nivestim treatment
Any measures taken with regard to Nivestim™ therapy (none, reduction of dose, discontinuation, temporary suspension).