Non-interventional safety study on the tolerability and safety of octagam® 5%, octagam® 10% or panzyga®

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

  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Health related quality of life
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional post-authorisation safety study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J06BA02) immunoglobulins, normal human, for intravascular adm.

  immunoglobulins, normal human, for intravascular adm.
• Medical condition to be studied:
  Secondary immunodeficiency

  Immunomodulatory therapy

  Primary immunodeficiency syndrome

Population studied

• Short description of the study population:
  It was planned to document the treatment of 5,000 patients. Patients of both genders and all ages who receive octagam® 5%, octagam® 10% or panzyga® for replacement therapy or immunomodulation as recommended by the corresponding SmPC could be enrolled. There were no additional formal inclusion or exclusion criteria defined.
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • 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)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  The main objective of the study is the evaluation of data on tolerability and safety of octagam® 5%, octagam® 10% and panzyga® in all labelled indications.
• Outcomes:
  The primary outcome is the number and the type of reported adverse drug reactions. Quality of life will be evaluated by using the SF-36 health Survey. Effectiveness by utilising laboratory data.
• Data analysis plan:
  Treatment with octagam® 5%, octagam® 10% and panzyga® is documented. This includes data about the patient's disease, age, gender, weight, concomitant medication or illness. For each application, the date and duration of infusion, dose, batch number(s) and the absence or occurrence of an adverse drug reaction (ADR) is recorded. In case of an ADR, additional detailed information about the reaction is recorded. If available, laboratory data about the efficacy of treatment should also be documented.