THE ASSESSMENT OF SAFETY PROFILE AND TOLERANCE OF ZOLEDRONIC ACID ACTAVIS® FORMULATION IN POLISH PATIENTS POPULATION

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  PASS study, non-interventional post-marketing study

Population studied

• Age groups:
  • 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)
• Estimated number of subjects:
  3500

Study design details

• Main study objective:
  Assessment of safety profile of ZOLEDRONIC ACID ACTAVIS in patients with advanced malignancy involving bone.
• Outcomes:
  Assessment of the tolerance of the treatment.
• Data analysis plan:
  This is a descriptive study, evaluating safety and tolerance of treatment with study drug, thus in this study basic statistical analysis will be performed by statistical and epidemiological methods, analise by Statistica version 10.On the basis of reported adverse events, the frequency of their occurrence in study population will be assessed. For the mostcommon adverse events the characteristics of subpopulation in which it was reported will be analyzed.