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

Name of medicine

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.