A Post-Marketing Safety Study to Evaluate the Occurrence of Aseptic Meningitis Syndrome (AMS) in an Adult Population (>= 18 Years) Treated with Doses of >= 1g/kg Intragam® 10 NF

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective observational study design

Study drug and medical condition

• Medical condition to be studied:
  Meningitis aseptic

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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To evaluate the occurrence of AMS cases in an adult population (>= 18 years of age) treated with doses of >= 1g/kg Intragam 10 NF.
• Outcomes:
  Confirmed or probable AMS in patients during treatment or within 7 days of the last dose of Intragam 10 NF (>= 1g/kg). Migraine and severe headache in patients during treatment or within 7 days of the last dose of Intragam 10 NF (>= 1g/kg).
• Data analysis plan:
  Descriptive statistics will be used to evaluate the occurrence of cases of AMS, severe headache and migraine in an adult population (>= 18 years of age) treated with doses of >= 1g/kg Intragam 10 NF. Generalised Linear regression methodology (e.g. logistic regression) will be adopted to evaluate the risk factors associated with confirmed or probable AMS occurring before or during treatment with doses of >= 1g/kg Intragam 10 NF.