Non-interventional prospective safety study as part of the routine pharmacovigilance in patients treated with Intratect 100 g / l (German title: Nicht-interventionelle prospektive Unbedenklichkeitsstudie im Rahmen der Routine-Pharmakovigilanz bei Intratect 100 g/l behandelten Patienten) (NIS Intratect 100 g/l)

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Intratect 100 g/l
• Medical condition to be studied:
  Primary immunodeficiency syndrome

  Secondary immunodeficiency

Population studied

• Short description of the study population:
  Patients with primary and secondary immune deficiency syndromes received treatment with intratect (100 g/l).
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The primary objective of the study is to gain additional insights on tolerance by broadening the database under real life conditions
• Outcomes:
  Adverse events dependent on relatedness and seriousness, Effectiveness, identification of patients at risk due to pre-existing illnesses and risk factors
• Data analysis plan:
  Descriptive statistics