Table 4.

Safety summary in the overall population and in participants < 2 years old

	Overall	Moderate HA	Severe HA
Overall population	N = 106	n = 15	n = 91
Participants who experienced ≥ 1 AE, n (%)	21 (19.8)	2 (13.3)	19 (20.9)
Total number of AEs	39	2	37
Participants who experienced ≥ 1 SAE*, n (%)	5 (4.7)	1 (6.7)	4 (4.4)
Total number of SAEs	7	1	6
Participants who interrupted treatment due to SAEs, n (%)	1 (0.9)	0 (0.0)	1 (1.1)
Participants who discontinued treatment due to SAEs, n (%)	0 (0.0)	0 (0.0)	0 (0.0)
Participants who experienced ≥ 1 adverse drug reaction, n (%)	3 (2.8)	0 (0.0)	3 (3.3)
Total number of adverse drug reactions†	4	0	4
Participants who experienced ≥ 1 serious adverse drug reaction, n (%)	0 (0.0)	0 (0.0)	0 (0.0)
Participants who interrupted or discontinued treatment due to adverse drug reactions, n (%)	0 (0.0)	0 (0.0)	0 (0.0)
Participants < 2 years old	N = 15	n = 1	n = 14
Participants who experienced ≥ 1 AE, n (%)	6 (40.0)	1 (100.0)	5 (35.7)
Total number of AEs	10	1	9
Participants who experienced ≥ 1 SAE n (%)	2 (13.3)	0 (0.0)	2 (14.3)
Total number of SAEs‡	2	0	2
Participants who interrupted or discontinued treatment due to SAEs, n (%)	0 (0.0)	0 (0.0)	0 (0.0)
Participants who experienced ≥ 1 adverse drug reaction, n (%)	0 (0.0)	0 (0.0)	0 (0.0)
Total number of adverse drug reactions	0	0	0
Participants who experienced ≥ 1 serious adverse drug reaction, n (%)	0 (0.0)	0 (0.0)	0 (0.0)
Participants who interrupted or discontinued treatment due to adverse drug reactions, n (%)	0 (0.0)	0 (0.0)	0 (0.0)

AE adverse event, HA haemophilia A, SAE serious adverse event

*SAEs included periodontitis, post-operative wound infection, anaemia, Kawasaki disease, sepsis, osteomyelitis, necrotising fasciitis

^†Adverse drug reactions included an injection-site reaction and an injection-site erythema in one participant, an injection-site reaction in another participant, and an injection-site erythema in a third

^‡The two SAEs in participants < 2 years old were anaemia and Kawasaki disease