Table 2.

The AAR incidence in patients with risk factors

		Conventional assessment group (%)	SAW group (%)	P value	RD (95%CI)
With/without risk factors	No risk	0.38 (372/97,439)	0.25 (274/108,786)	< 0.001	0.13 (0.08, 0.18)
	At risk	0.57 (134/23,383)	0.34 (140/41,557)	< 0.001	0.24 (0.13, 0.35)
	P value	< 0.001	0.01
Patients with no risk	Mild AAR	0.35 (339/97,439)	0.24 (264/108,786)	< 0.001	0.105 (0.06, 0.15)
	Moderate AAR	0.03 (29/97,439)	0.007 (8/108,786)	< 0.001	0.02 (0.01, 0.03)
	Severe AAR	0.004 (4/97,439)	0.002 (2/108,786)	0.43	0.002 (− 0.003, 0.007)
Patients at risk	Mild AAR	0.52 (121/23,383)	0.33 (135/41,557)	< 0.001	0.19 (0.09, 0.30)
	Moderate AAR	0.04 (10/23,383)	0.007 (3/41,557)	0.01	0.04 (0.01, 0.07)
	Severe AAR	0.01 (3/23,383)	0.005 (2/41,557)	0.36	0.008 (− 0.01, 0.03)
Risk level	Low risk	0.45 (75/16,746)	0.32 (99/30,583)	0.03	0.12 (0.005, 0.24)
	High risk	0.89 (59/6637)	0.37 (41/10,974)	< 0.001	0.52 (0.26, 0.77)
	P value	< 0.001	0.44
Number of risk factors	Single risk	0.55 (116/21,074)	0.32 (117/36,135)	< 0.001	0.23 (0.11, 0.34)
	Multi-risk	0.78 (18/2309)	0.42 (23/5422)	0.049	0.36 (− 0.04, 0.75)

AAR, acute adverse reactions; SAW, stratified assessment and warning; RD, rate difference; CI, confidence interval