Table 2.

Maximum grade of adverse events per patient

Adverse event	Cohort 1, N = 6		Cohort 2, N = 10		All cohort, N = 16 (%)
	Grade		Grade		Grade
	1–2	≥ 3	1–2	≥ 3	1–2	≥ 3
Laboratory data
Neutropenia	0	0	0	0	0	0
Lymphopenia	0	0	2	0	2 (12.5)	0
Anemia	2	0	2	0	4 (25.0)	0
Thrombocytopenia	0	0	3	0	3 (18.8)	0
Elevated AST	1	0	1	1*	2 (12.5)	1* (6.3)
Elevated ALT	1	0	3	0	4 (25.0)	0
Elevated ALP	0	0	1	0	1 (6.3)	0
Elevated total bilirubin	0	0	1	0	1 (6.3)	0
Elevated creatinine	0	0	3	0	3 (18.8)	0
Hyponatremia	2	0	3	0	5 (31.3)	0
Hypokalemia	0	0	1	0	1 (6.3)	0
Hypocalcemia	0	0	1	0	1 (6.3)	0
Clinical findings
Injection site reaction†	5	0	8	0	13 (86.7)	0
Fatigue	3	0	3	0	6 (37.5)	0
Fever	4	0	4	0	8 (50.0)	0
Anorexia	0	0	3	0	3 (18.8)	0
Nausea	2	0	2	0	4 (25.0)	0
Diarrhea	2	0	3	0	5 (31.3)	0
Constipation	3	0	3	0	6 (37.5)	0
Headache	2	0	0	0	2 (12.5)	0
Mucositis	0	0	0	0	0	0
Pneumonitis	0	0	1	0	0	0
Bronchial stenosis	0	1*	0	0	0	1* (6.3)
Esophagobronchial fistula	0	1*	0	0	0	1* (6.3)
Acute coronary syndrome	0	0	0	1*	0	1* (6.3)
Bullous dermatitis	0	0	2	0	2 (12.5)	0

*These grade 3 or over events were considered unrelated to the vaccine treatment. ^†Evaluation in 15 cases other than No.8 patient