Table 4.

Summary of AEs^*

	Arm 1: individualized prophylaxis (n = 117)	Arm 2: weekly prophylaxis (n = 24)	Arm 3: episodic treatment (n = 23)
Total AEs, n	219	46	23
Subjects with ≥1 AE, n (%)	80 (68.4)	18 (75.0)	10 (43.5)
Most common AEs, ≥3%, n (%)
Nasopharyngitis	16 (13.7)	1 (4.2)	3 (13.0)
Arthralgia	10 (8.5)	2 (8.3)	1 (4.3)
Upper respiratory tract infection	6 (5.1)	0 (0)	3 (13.0)
Headache	5 (4.3)	6 (25.0)	2 (8.7)
Influenza	5 (4.3)	0 (0)	0 (0)
Pyrexia	3 (2.6)	1 (4.2)	1 (4.3)
Subjects with 1 or more SAE†	10 (8.5)	2 (8.3)	0 (0.0)

^*Excludes the perioperative period.

^†SAEs in arms 1, 2, and 3 (excluding the perioperative period) included face injury, femur fracture, back pain with associated syncope, hemarthrosis, lumbar spinal stenosis, myalgia, inguinal hernia, tooth disorder, restless leg syndrome, polysubstance overdose and completed suicide, nephrolithiasis, respiratory distress, tachycardia, and hypertensive emergency. The incidence of individual SAEs was 0.6%, with all occurring in 1 subject each. None of the reported 17 SAEs, including 1 death secondary to polysubstance overdose (suicide) in a subject with prior history of depression, were considered by the investigator as related to rFVIIIFc treatment. One SAE (femur fracture) indirectly resulted in discontinuation of rFVIIIFc treatment and withdrawal from the study because the subject required surgery to treat the fracture and did not have the 12 EDs required for enrolling in the surgery subgroup.