Table 2.

Incidence rate of hypersensitivity reaction and anaphylactic shock.

Hypersensitivity reaction	Incidence rate (95% CI)
By subjects (15 of 8,580)Male (7 of 4,081)Female (8 of 4,499)	0.175% (0.086–0.263)0.172% (0.045–0.298)0.178% (0.055–0.301)
By treatments (15 of 60,654)Male (7 of 28,626)Female (8 of 32,028)	0.025% (0.012–0.037)0.024% (0.006–0.043)0.025% (0.008–0.042)
Anaphylaxis shock	Incidence rate (95% CI)
By subjects (4 of 8,580) Male (1 of 4,081)Female (3 of 4,49	0.047% (0.001–0.092) 0.025% (-0.024–0.073) 0.067% (-0.009–0.142)
By treatments (4 of 60,654) Male (1 of 28,626) Female (3 of 32,028)	0.007% (0.000–0.013) 0.003% (-0.003–0.010) 0.009% (-0.001–0.020)
Severity of symptom	Frequency (%)
Grade 1 (Mild)Grade 2 (Moderate)Grade 3 (Severe)	6 (male 4, female 2), 40.0%7 (male 3, female 4), 46.7%2 (male 0, female 2), 13.3%