Table 3 Evaluation of AEs in NEXT and VENICE

All AEs will be evaluated according to:

•

Clinical relevance

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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

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Any measures taken with regard to Nivestim™ therapy (none, reduction of dose, discontinuation, temporary suspension).