A Non-Interventional Prospective Study to Evaluate The Safety Of Long Term Use Of Accofil In Patients With Severe Chronic Neutropenia Enrolled In The Severe Chronic Neutropenia International Registry (SCNIR)

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) who were treated with Accofil (filgrastim).
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • 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)
• Special population of interest:
  Pregnant women
• 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 Accofil (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 Accofil. The evaluation will focus on Patient Characteristics (age, gender, neutropenia diagnosis), Clinical Characteristics, Treatment, Adverse Events, Deaths, Pregnancy