Non-interventional long term study (NIS) for the clinical usage of Biotest IVIGs in various indications (Biotest NIS-020)

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:
  Sentinel sites

Study drug and medical condition

• Medical condition to be studied:
  Neuropathy peripheral

  Myasthenia gravis

  Primary immunodeficiency syndrome

  Secondary immunodeficiency

Population studied

• Age groups:
  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)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The aim of the study is to gain knowledge about the efficacy and patient satisfaction. Further study objectives are an additional gain in knowledge about tolerance and safety by broadening the database under everyday conditions.
• Data analysis plan:
  The statistical evaluations are carried out using the SAS program. The quantitative variables are described by number of values, mean, median, standard deviation, where appropriate, confidence interval, minimum and maximum. The qualitative variables are represented with the help of absolute (n) and relative (%) frequencies.