Postmarketing Requirement (PMR) Non-Interventional 2-armed Study to Evaluate the Safety of octagam® Immune Globulin Intravenous (Human) 5% Liquid Preparation, with a Special Emphasis on Monitoring, Analysis and Reporting of Thromboembolic Events (TEEs) (GAM5-28)

Study type

• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• If ‘Not applicable’, further details on the study type:
  Active surveillance

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:
  Primary immunodeficiency syndrome

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)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To assess and evaluate the safety profile of octagam 5% under routine clinical use, with a special emphasis on the occurrence of TEEs. The incidence of TEEs in patients receiving octagam 5% will be compared with the incidence rate in a matching concurrent control group of patients receiving other IVIGs for routine clinical use.
• Outcomes:
  Thromboembolic event (TEE), Adverse drug reactions
• Data analysis plan:
  The primary objective of this study is the close monitoring of the occurrence of TEEs. This statistical monitoring will be carried out by means of the Maximized Sequential Probability Ratio TEST (MaxSPRT) for Binomial data, cf. Kulldorff et. al. 2011