TABLE 4.

Characteristics of 48 safety reports including 99 adverse events reported as serious adverse events.

Patient demographics of 48 ICSRs a	n (%)
Age at the time of occurrence
0–27 days	0 (0.0)
28 days to 1 year	1 (2.2)
2–11 years	0 (0.0)
12–18 years	1 (2.2)
19–64 years	34 (75.6)
65 years ∼	9 (20.0)
Sex
Male	17 (35.4)
Female	31 (64.6)
Category of serious adverse event in 48 ICSRs/99 adverse events b
Death	2 (4.2)/8 (8.1)
Life-threatening	3 (6.3)/3 (3.0)
Hospitalization (initial or prolonged)	31 (64.6)/51 (51.5)
Disability or permanent damage	0 (0.0)/0 (0.0)
Congenital anomaly/birth defect	0 (0.0)/0 (0.0)
Important medical events	16 (33.3)/43 (43.4)
99 adverse events classified by System Organ Class
Skin and subcutaneous tissue disorders	19 (19.2)
Investigations	17 (17.2)
Respiratory, thoracic and mediastinal disorders	12 (12.1)
General disorders and administration site conditions	10 (10.1)
Gastrointestinal disorders	9 (9.1)
Nervous system disorders	6 (6.1)
Eye disorders	4 (4.0)
Immune system disorders	4 (4.0)
Infections and infestations	4 (4.0)
Hepatobiliary disorders	3 (3.0)
Musculoskeletal and connective tissue disorders	3 (3.0)
Metabolism and nutrition disorders	2 (2.0)
Psychiatric disorders	2 (2.0)
Blood and lymphatic system disorders	1 (1.0)
Cardiac disorders	1 (1.0)
Injury, poisoning and procedural complications	1 (1.0)
Vascular disorders	1 (1.0)

^a Three patients had missing age data.

^b An ICSR, and an adverse event can be classified under more than two serious adverse event categories.