Tolerability and safety of the intravenous immunoglobulin octagam 10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials.

Objectives: To provide detailed data on the tolerability and safety of octagam 10%, a ready-to-use intravenous immunoglobulin, in a subgroup of patients with immune thrombocytopenia (ITP) involved in an integrated analysis of post-authorisation safety surveillance (PASS) studies.

Methods: A subgroup analysis was conducted using data collected from two non-interventional studies that included patients with ITP treated with octagam 10%. Patients were observed and monitored for possible adverse drug reactions (ADRs) during or after administration of octagam 10%, with a particular focus on thromboembolic events (TEEs).

Tolerability and safety of Octagam® (IVIG): a post-authorization safety analysis of four non-interventional phase IV trials .

Objective: To evaluate the tolerability and safety of Octagam 5% and 10% across all indications, ages, and treatment regimens, using data from four non-interventional post-authorization safety studies (PASS); this analysis was performed following changes in the preparation of raw material used to manufacture Octagam.

Methods: All four studies included in- and out-patients prescribed Octagam for treatment of their medical condition. Physicians used case report forms to document baseline demographics, Octagam treatment details, and data on the efficacy of Octagam, and recorded all adverse drug reactions (ADRs) and other safety data.