Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Non-Interventional Prospective Study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L03AA02) filgrastim
filgrastim

Medical condition to be studied

Neutropenia
Population studied

Short description of the study population

Patients With Severe Chronic Neutropenia Enrolled In The Severe Chronic Neutropenia International Registry (SCNIR)

Age groups

  • Paediatric Population (< 18 years)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Pregnant women
Other

Special population of interest, other

Severe Chronic Neutropenia patients

Estimated number of subjects

500
Study design details

Main study objective

The objectives are 1) to monitor and assess long term safety of SCN patients treated with Grastofil (filgrastim) 2) to study the incidence and outcome of identified and potential risks such as osteoporosis, splenomegaly, cytogenetic abnormalities, myelodysplastic syndrome, and leukemia

Data analysis plan

Data analysis and reports are generated twice yearly on Grastofil. The evaluation will focus on Patient Characteristics (age, gender, neutropenia diagnosis), Clinical Characteristics, Treatment, Adverse Events, Deaths, Pregnancy