TABLE 1.

Treatment-Emergent (Regardless of Causality) and Treatment-Related AEs Occurring in ≥1% of Subjects (Safety-Evaluable Population)

Preferred Term	Sakura 3 (N = 2691), n (%)
Treatment-emergent AEs regardless of causality
Headache	158 (5.9)
Nasopharyngitis	119 (4.4)
Injection site pain	105 (3.9)
Injection site erythema	90 (3.3)
Injection site edema	76 (2.8)
Erythema	56 (2.1)
Upper respiratory tract infection	55 (2.0)
Sinusitis	49 (1.8)
Edema	47 (1.7)
Urinary tract infection	42 (1.6)
Influenza	37 (1.4)
Eyelid ptosis	35 (1.3)
Injection site bruising	32 (1.2)
Injection site pruritus	29 (1.1)
Treatment-related AEs
Headache	124 (4.6)
Injection site pain	98 (3.6)
Injection site erythema	81 (3.0)
Injection site edema	76 (2.8)
Erythema	48 (1.8)
Edema	47 (1.6)
Eyelid ptosis	34 (1.3)

AE, adverse event.