Table 11.

Adverse Events Occurring in More Than 4% of Subjects^* Receiving Berinert^® at Either 10 Units/kg or 20 units/kg 7 to 9 Days after Infusion, Irrespective of Causality

Adverse events	Number (%) of subjects reporting adverse events (n=108)
Hereditary angioedema	12 (11.1%)
Headache	12 (11.1%)
Abdominal pain†	7 (6.5%)
Nausea†	7 (6.5%)
Muscle spasms	6 (5.6%)
Pain	6 (5.6%)
Diarrhea†	5 (4.6%)
Vomiting†	5 (4.6%)

^*Includes subjects in the placebo group who received Berinert^® 20 units/kg as rescue study medication.

^†These symptoms were identified in the protocol as related to the underlying disease. Any increase in intensity or new occurrence of these symptoms after study medication administration was considered to be an adverse event.

Source: Berinert^® Prescribing Information 2009.