Table 4.

Summary of TEAEs by hemophilia type

	HA concizumab (N = 36)		HAwI concizumab (N = 9)		HBwI concizumab (N = 8)		HAwI/HBwI rFVIIa on demand (N = 9)
	n (%)	E [R]	n (%)	E [R]	n (%)	E [R]	n (%)	E [R]
Exposure time, y	17.2		6.1		5.6		3.9
All AEs	29 (80.6)	130 [7.6]	7 (77.8)	20 [3.3]	6 (75.0)	23 [4.1]	7 (77.8)	18 [4.7]
Serious AEs	0		0		1 (12.5)	1 [0.2]	3 (33.3)	4 [1.0]
Severe	0		0		0		0
Fatal	0		0		0		0
AEs leading to withdrawal	0		0		0		0
Most frequent AEs, ≥5%
General disorders and administration site conditions
Injection site bruising	5 (13.9)	8 [0.5]	0		0		0
Injection site hematoma	4 (11.1)	5 [0.3]	1 (11.1)	1 [0.2]	2 (25.0)	5 [0.9]	0
Injection site hemorrhage	3 (8.3)	6 [0.4]	0		1 (12.5)	5 [0.9]	0
Infections and infestations
Nasopharyngitis	9 (25.0)	12 [0.7]	0		3 (37.5)	3 [0.5]	0
Upper respiratory tract infection	2 (5.6)	2 [0.1]	1 (11.1)	2 [0.3]	0		1 (11.1)	1 [0.3]

Summary of TEAEs by hemophilia type in patients who received concizumab during explorer4 (HAwI/HBwI) and explorer5 (HA without inhibitors) (safety analysis set).

%, percentage of patients with adverse event; E, number of AEs; R, rate calculated as the number of AEs per patient-years of exposure.