A multinational, multi-centre, prospective, non-interventional, post-authorisation safety study in healthy donors (HDs) exposed to Nivestim (biosimilar filgrastim) for haematopoietic stem cell (HSC) mobilisation (NEST)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Study drug and medical condition

• Medicinal product name:
  NIVESTIM

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  To describe types and rates of adverse drug reactions (ADRs) and adverse events of special interest (AESI), especially new malignancies, in healthy donors (HDs) treated with Nivestim.
• Outcomes:
  To describe the HD population exposed to Nivestim for HSC mobilisation. To describe effectiveness of Nivestim in HSC mobilisation in HDs.
• Data analysis plan:
  Continuous variables will be described (distribution) by their mean, standard deviation, median, quartiles 1 and 3, extreme values (minimum and maximum) and the number of missing data. Categorical variables will be described (frequency) by their total and percentage and the number of missing data.