Table 2.

Signal mining analysis at the system organ class level

System organ class	N	ROR (95%CI)	IC (95%CI)
General disorders and administration site conditions	974	3.82(3.24 ~ 4.51)	0.49(0.39 ~ 0.57)
Injury, poisoning and procedural complications	536	3.84(3.42 ~ 4.32)	1.32(1.18 ~ 1.43)
Infections and infestations	410	3.36(2.98 ~ 3.79)	1.32(1.16 ~ 1.44)
Neoplasms benign, malignant, and unspecified (incl cysts and polyps)	367	10.49(9.26 ~ 11.88)	2.88(2.70 ~ 3.00)
Skin and subcutaneous tissue disorders	226	1.33(1.15 ~ 1.54)	0.34(0.12 ~ 0.50)
Gastrointestinal disorders	147	0.71(0.59 ~ 0.84)	-0.42(-0.70 ~ -0.23)
Nervous system disorders	110	0.49(0.40 ~ 0.60)	-0.89(-1.20 ~ -0.66)
Investigations	91	1.04(0.84 ~ 1.29)	0.06(-0.29 ~ 0.31)
Vascular disorders	90	0.94(0.76 ~ 1.16)	-0.08(-0.43 ~ 0.17)
Respiratory, thoracic, and mediastinal disorders	60	0.60(0.46 ~ 0.78)	-0.69(-1.11 ~ -0.38)
Musculoskeletal and connective tissue disorders	55	0.50(0.38 ~ 0.65)	-0.93(-1.38 ~ -0.61)
Renal and urinary disorders	41	1.10(0.81 ~ 1.51)	0.13(-0.39 ~ 0.50)
Metabolism and nutrition disorders	40	0.89(0.65 ~ 1.23)	-0.15(-0.68 ~ 0.22)
Blood and lymphatic system disorders	37	0.93(0.67 ~ 1.29)	-0.10(-0.64 ~ 0.29)
Psychiatric disorders	35	0.39(0.28 ~ 0.55)	-1.27(-1.83 ~ -0.87)
Cardiac disorders	32	0.56(0.39 ~ 0.80)	-0.79(-1.38 ~ -0.37)
Hepatobiliary disorders	27	2.68(1.83 ~ 3.93)	1.36(0.67 ~ 1.80)
Eye disorders	18	0.68(0.43 ~ 1.09)	-0.53(-1.31 ~ 0.02)
Surgical and medical procedures	18	1.29(0.81 ~ 2.06)	0.35(-0.45 ~ 0.90)
Immune system disorders	15	0.58(0.35 ~ 0.97)	-0.75(-1.60 ~ -0.14)
Endocrine disorders	14	5.44(3.21 ~ 9.21)	2.22(0.99 ~ 2.76)
Product issues	13	0.92(0.53 ~ 1.60)	-0.11(-1.04 ~ 0.53)
Social circumstances	8	1.79(0.89 ~ 3.59)	0.77(-0.54 ~ 1.55)
Ear and labyrinth disorders	7	1.13(0.54 ~ 2.39)	0.17(-1.15 ~ 1.02)
Reproductive system and breast disorders	2	4.93(1.23 ~ 19.76)	1.46(-2.94 ~ 2.40)

Bold text denotes significant positive signals

ROR Reporting odds ratio, CI Confidence interval