Table 4. Adverse events.

Adverse events	Control group	Test group	P value
	(N = 435)	(N = 401)
	No. of patients (%)
Any adverse events	203 (46.7)	224 (55.9)	0.009*
Serious adverse events	14 (3.2)	12 (3.0)	1.000
Aortic valve stenosis	0 (0.0)	1 (0.2)	0.480
Haematemesis	1 (0.2)	0 (0.0)	1.000
Salivary gland calculus	0 (0.0)	1 (0.2)	0.480
Large intestine polyp	1 (0.2)	0 (0.0)	1.000
Death	2 (0.5)	1 (0.2)	1.000
Cholecystitis acute	0 (0.0)	1 (0.2)	0.480
Disseminated tuberculosis	1 (0.2)	0 (0.0)	1.000
Septic shock	0 (0.0)	1 (0.2)	0.480
Tibia fracture	1 (0.2)	0 (0.0)	1.000
Lumbar spinal stenosis	1 (0.2)	0 (0.0)	1.000
Bladder cancer	0 (0.0)	1 (0.2)	0.480
Breast cancer female	0 (0.0)	1 (0.2)	0.480
Gastric cancer	1 (0.2)	2 (0.5)	0.610
Lung cancer	1 (0.2)	1 (0.2)	1.000
Malignant pleural effusion	0 (0.0)	1 (0.2)	0.480
Pancreatic cancer	1 (0.2)	1 (0.2)	1.000
Renal cancer	1 (0.2)	0 (0.0)	1.000
Tongue neoplasm malignant stage unspecified	1 (0.2)	0 (0.0)	1.000
Hepatocellular carcinoma	1 (0.2)	1 (0.2)	1.000
Cerebral hemorrhage	1 (0.2)	0 (0.0)	1.000
Depression	1 (0.2)	0 (0.0)	1.000
Hypoxia	1 (0.2)	0 (0.0)	1.000
Aspiration pneumonia	0 (0.0)	1 (0.2)	0.480
Blue toe syndrome	1 (0.2)	0 (0.0)	1.000

Fisher's exact test was used to evaluate the significance of differences between groups.

^*The level of significance was set at p < 0.05 (2-sided).