Table III.

Summary of total and most frequent adverse events (≥10% in either study) experienced during surgical-phase treatment with VWF/FVIII concentrate.

	Number (%) of subjects
Adverse Event	USA (n =35)	EU (n =28)	Pooled (n =63)
Any AE	30 (86%)	21 (75%)	51 (81%)
Possibly related AE	3 (9%)	5 (18%)	8 (13%)
Nausea	13 (37%)	2 (7.1%)	15 (24%)
Constipation	5 (14%)	2 (7.1%)	7 (11%)
Dizziness	5 (14%)	0	5 (8%)
Pain	5 (14%)	6 (21.4%)	11 (17%)
Fever	4 (11%)	0	4 (6%)
Haemorrhage*	4 (11%)	6 (21.4%)	10 (16%)
Epistaxis	2 (6%)	3 (10.7%)	5 (8%)
Headache	1 (3%)	3 (10.7%)	4 (6%)

Legend AE: adverse event; FVIII: factor VIII; VWF: von Willebrand factor;

^*Only comprises events coded as "haemorrhage".