Heart Protection Study (HPS)

Serious adverse events by MedDRA classification

These results are organised hierarchically by MedDRA SOC, HLGT and HLT categories. To expand a row to show the next level of the hierarchy, click the + symbol; to contract it, click the - symbol.

Simvastatin comparison: Fatal or non-fatal serious adverse events in all patients

	MedDRA term	Active simvastatin		Placebo simvastatin		Risk ratio (95% CI)		Absolute excess (SE)
	Any event	6924	(67.4%)	7273	(70.8%)	0.90	(0.88- 0.94)	-3.41%	( 0.64%)
	Blood and lymphatic system disorders	108	( 1.1%)	102	( 1.0%)	1.05	(0.80- 1.38)	0.06%	( 0.14%)
	Anaemias nonhaemolytic and marrow depression	83	( 0.8%)	85	( 0.8%)	0.97	(0.72- 1.31)	-0.02%	( 0.13%)
	Anaemia deficiencies	19	( 0.2%)	22	( 0.2%)	0.86	(0.46- 1.58)	-0.03%	( 0.06%)
	Anaemias NEC	63	( 0.6%)	62	( 0.6%)	1.01	(0.71- 1.43)	0.01%	( 0.11%)
	Marrow depression and hypoplastic anaemias	3	( 0.0%)	3	( 0.0%)	0.99	(0.20- 4.92)	-0.00%	( 0.02%)
	Haematological disorders NEC	2	( 0.0%)	1	( 0.0%)	1.93	(0.20- 18.53)	0.01%	( 0.02%)
	Haematological disorders	2	( 0.0%)	1	( 0.0%)	1.93	(0.20- 18.53)	0.01%	( 0.02%)
	Haemolyses and related conditions	2	( 0.0%)	0	( 0.0%)	7.35	(0.46-117.46)	0.02%	( 0.01%)
	Anaemias haemolytic NEC	2	( 0.0%)	0	( 0.0%)	7.35	(0.46-117.46)	0.02%	( 0.01%)
	Platelet disorders	7	( 0.1%)	9	( 0.1%)	0.77	(0.29- 2.06)	-0.02%	( 0.04%)
	Platelet disorders NEC	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.61)	-0.02%	( 0.02%)
	Thrombocytopenias	3	( 0.0%)	3	( 0.0%)	0.99	(0.20- 4.92)	-0.00%	( 0.02%)
	Thrombocytoses	3	( 0.0%)	3	( 0.0%)	0.99	(0.20- 4.91)	-0.00%	( 0.02%)
	Red blood cell disorders	6	( 0.1%)	4	( 0.0%)	1.48	(0.43- 5.10)	0.02%	( 0.03%)
	Polycythaemia (excl rubra vera)	6	( 0.1%)	4	( 0.0%)	1.48	(0.43- 5.10)	0.02%	( 0.03%)
	Spleen, lymphatic and reticuloendothelial system disorders	2	( 0.0%)	1	( 0.0%)	1.93	(0.20- 18.58)	0.01%	( 0.02%)
	Lymphatic system disorders NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.96)	-0.00%	( 0.01%)
	Spleen disorders	1	( 0.0%)	0	( 0.0%)	7.25	(0.14-365.27)	0.01%	( 0.01%)
	Coagulopathies and bleeding diatheses (excl thrombocytopenic)	8	( 0.1%)	4	( 0.0%)	1.93	(0.62- 5.99)	0.04%	( 0.03%)
	Coagulopathies	8	( 0.1%)	4	( 0.0%)	1.93	(0.62- 5.99)	0.04%	( 0.03%)
	Cardiac disorders	2080	(20.3%)	2533	(24.7%)	0.80	(0.75- 0.84)	-4.42%	( 0.58%)
	Cardiac arrhythmias	354	( 3.4%)	326	( 3.2%)	1.08	(0.93- 1.25)	0.27%	( 0.25%)
	Cardiac conduction disorders	12	( 0.1%)	9	( 0.1%)	1.32	(0.56- 3.10)	0.03%	( 0.04%)
	Rate and rhythm disorders NEC	91	( 0.9%)	95	( 0.9%)	0.95	(0.71- 1.26)	-0.04%	( 0.13%)
	Supraventricular arrhythmias	220	( 2.1%)	209	( 2.0%)	1.04	(0.86- 1.26)	0.11%	( 0.20%)
	Ventricular arrhythmias and cardiac arrest	60	( 0.6%)	38	( 0.4%)	1.56	(1.05- 2.31)	0.21%	( 0.10%)
	Cardiac disorder signs and symptoms	19	( 0.2%)	25	( 0.2%)	0.76	(0.42- 1.36)	-0.06%	( 0.06%)
	Cardiac disorders NEC	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.15)	-0.02%	( 0.01%)
	Cardiac hypertensive complications	1	( 0.0%)	4	( 0.0%)	0.30	(0.05- 1.72)	-0.03%	( 0.02%)
	Cardiac signs and symptoms NEC	18	( 0.2%)	19	( 0.2%)	0.94	(0.49- 1.79)	-0.01%	( 0.06%)
	Coronary artery disorders	1635	(15.9%)	2080	(20.3%)	0.77	(0.72- 0.82)	-4.34%	( 0.54%)
	Coronary artery disorders NEC	234	( 2.3%)	286	( 2.8%)	0.81	(0.68- 0.96)	-0.51%	( 0.22%)
	Ischaemic coronary artery disorders	1440	(14.0%)	1851	(18.0%)	0.76	(0.71- 0.81)	-4.01%	( 0.51%)
	Endocardial disorders	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.85)	-0.00%	( 0.01%)
	Endocardial disorders NEC	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.79)	-0.01%	( 0.01%)
	Endocardial bacterial infections	1	( 0.0%)	0	( 0.0%)	7.29	(0.14-367.52)	0.01%	( 0.01%)
	Heart failures	316	( 3.1%)	361	( 3.5%)	0.87	(0.74- 1.01)	-0.44%	( 0.25%)
	Heart failures NEC	166	( 1.6%)	170	( 1.7%)	0.97	(0.78- 1.20)	-0.04%	( 0.18%)
	Left ventricular failures	176	( 1.7%)	222	( 2.2%)	0.78	(0.64- 0.96)	-0.45%	( 0.19%)
	Right ventricular failures	6	( 0.1%)	6	( 0.1%)	0.99	(0.32- 3.06)	-0.00%	( 0.03%)
	Myocardial disorders	71	( 0.7%)	85	( 0.8%)	0.83	(0.60- 1.13)	-0.14%	( 0.12%)
	Cardiomyopathies	71	( 0.7%)	84	( 0.8%)	0.84	(0.61- 1.15)	-0.13%	( 0.12%)
	Myocardial disorders NEC	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.71)	-0.01%	( 0.01%)
	Pericardial disorders	14	( 0.1%)	11	( 0.1%)	1.26	(0.57- 2.76)	0.03%	( 0.05%)
	Pericardial disorders NEC	5	( 0.0%)	0	( 0.0%)	7.31	(1.27- 42.19)	0.05%	( 0.02%)
	Noninfectious pericarditis	9	( 0.1%)	11	( 0.1%)	0.81	(0.34- 1.95)	-0.02%	( 0.04%)
	Cardiac valve disorders	10	( 0.1%)	12	( 0.1%)	0.83	(0.36- 1.90)	-0.02%	( 0.05%)
	Aortic valvular disorders	2	( 0.0%)	3	( 0.0%)	0.66	(0.11- 3.82)	-0.01%	( 0.02%)
	Mitral valvular disorders	4	( 0.0%)	2	( 0.0%)	1.93	(0.39- 9.57)	0.02%	( 0.02%)
	Cardiac valve disorders NEC	5	( 0.0%)	7	( 0.1%)	0.71	(0.23- 2.20)	-0.02%	( 0.03%)
	Congenital, familial and genetic disorders	9	( 0.1%)	5	( 0.0%)	1.74	(0.61- 4.96)	0.04%	( 0.04%)
	Blood and lymphatic system disorders congenital	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.90)	-0.00%	( 0.01%)
	Coagulation disorders congenital	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.67)	0.01%	( 0.01%)
	Haemoglobinopathies congenital	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.80)	-0.01%	( 0.01%)
	Cardiac and vascular disorders congenital	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.71)	-0.01%	( 0.01%)
	Cardiac septal defects congenital	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.71)	-0.01%	( 0.01%)
	Eye disorders congenital	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.74)	-0.01%	( 0.01%)
	Corneal and scleral disorders congenital	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.74)	-0.01%	( 0.01%)
	Gastrointestinal tract disorders congenital	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.75)	-0.01%	( 0.01%)
	Gastric disorders congenital	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.75)	-0.01%	( 0.01%)
	Reproductive tract and breast disorders congenital	6	( 0.1%)	1	( 0.0%)	4.14	(0.94- 18.22)	0.05%	( 0.03%)
	Male reproductive tract disorders congenital	6	( 0.1%)	1	( 0.0%)	4.14	(0.94- 18.22)	0.05%	( 0.03%)
	Skin and subcutaneous tissue disorders congenital	2	( 0.0%)	0	( 0.0%)	6.91	(0.43-110.86)	0.02%	( 0.01%)
	Skin and subcutaneous tissue disorders congenital NEC	2	( 0.0%)	0	( 0.0%)	6.91	(0.43-110.86)	0.02%	( 0.01%)
	Ear and labyrinth disorders	17	( 0.2%)	19	( 0.2%)	0.89	(0.46- 1.70)	-0.02%	( 0.06%)
	Hearing disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.01%	( 0.01%)
	Hearing losses	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.01%	( 0.01%)
	Inner ear and VIIIth cranial nerve disorders	14	( 0.1%)	12	( 0.1%)	1.16	(0.54- 2.49)	0.02%	( 0.05%)
	Inner ear signs and symptoms	12	( 0.1%)	9	( 0.1%)	1.32	(0.56- 3.10)	0.03%	( 0.04%)
	Inner ear disorders NEC	2	( 0.0%)	3	( 0.0%)	0.66	(0.11- 3.83)	-0.01%	( 0.02%)
	Middle ear disorders (excl congenital)	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.43)	0.01%	( 0.01%)
	Middle ear disorders NEC	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.43)	0.01%	( 0.01%)
	Aural disorders NEC	2	( 0.0%)	6	( 0.1%)	0.36	(0.09- 1.46)	-0.04%	( 0.03%)
	Ear disorders NEC	2	( 0.0%)	6	( 0.1%)	0.36	(0.09- 1.46)	-0.04%	( 0.03%)
	Endocrine disorders	43	( 0.4%)	25	( 0.2%)	1.68	(1.05- 2.71)	0.18%	( 0.08%)
	Adrenal gland disorders	6	( 0.1%)	2	( 0.0%)	2.70	(0.68- 10.80)	0.04%	( 0.03%)
	Adrenal cortical hyperfunctions	2	( 0.0%)	0	( 0.0%)	7.35	(0.46-117.54)	0.02%	( 0.01%)
	Adrenal cortical hypofunctions	4	( 0.0%)	2	( 0.0%)	1.94	(0.39- 9.59)	0.02%	( 0.02%)
	Hypothalamus and pituitary gland disorders	2	( 0.0%)	1	( 0.0%)	1.93	(0.20- 18.60)	0.01%	( 0.02%)
	Posterior pituitary disorders	2	( 0.0%)	1	( 0.0%)	1.93	(0.20- 18.60)	0.01%	( 0.02%)
	Neoplastic and ectopic endocrinopathies	3	( 0.0%)	2	( 0.0%)	1.48	(0.26- 8.54)	0.01%	( 0.02%)
	Ectopic endocrine disorders	3	( 0.0%)	2	( 0.0%)	1.48	(0.26- 8.54)	0.01%	( 0.02%)
	Thyroid gland disorders	33	( 0.3%)	21	( 0.2%)	1.55	(0.91- 2.63)	0.12%	( 0.07%)
	Thyroid disorders NEC	3	( 0.0%)	4	( 0.0%)	0.75	(0.17- 3.28)	-0.01%	( 0.03%)
	Thyroid hyperfunction disorders	7	( 0.1%)	6	( 0.1%)	1.16	(0.39- 3.43)	0.01%	( 0.04%)
	Thyroid hypofunction disorders	24	( 0.2%)	11	( 0.1%)	2.08	(1.07- 4.04)	0.13%	( 0.06%)
	Thyroid neoplasms	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.01%	( 0.01%)
	Eye disorders	106	( 1.0%)	98	( 1.0%)	1.07	(0.82- 1.41)	0.08%	( 0.14%)
	Anterior eye structural change, deposit and degeneration	39	( 0.4%)	21	( 0.2%)	1.81	(1.09- 3.01)	0.18%	( 0.08%)
	Cataract conditions	37	( 0.4%)	20	( 0.2%)	1.81	(1.08- 3.04)	0.17%	( 0.07%)
	Corneal structural change, deposit and degeneration	2	( 0.0%)	1	( 0.0%)	1.93	(0.20- 18.55)	0.01%	( 0.02%)
	Eye disorders NEC	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.79)	0.01%	( 0.01%)
	Lacrimal disorders	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.79)	0.01%	( 0.01%)
	Ocular infections, irritations and inflammations	3	( 0.0%)	1	( 0.0%)	2.69	(0.38- 19.09)	0.02%	( 0.02%)
	Conjunctival infections, irritations and inflammations	1	( 0.0%)	0	( 0.0%)	7.26	(0.14-366.20)	0.01%	( 0.01%)
	Iris and uveal tract infections, irritations and inflammations	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.43)	0.01%	( 0.01%)
	Ocular infections, inflammations and associated manifestations	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.85)	-0.00%	( 0.01%)
	Ocular neuromuscular disorders	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.96)	-0.00%	( 0.01%)
	Eyelid movement disorders	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.96)	-0.00%	( 0.01%)
	Ocular structural change, deposit and degeneration NEC	15	( 0.1%)	16	( 0.2%)	0.93	(0.46- 1.88)	-0.01%	( 0.05%)
	Retinal structural change, deposit and degeneration	15	( 0.1%)	16	( 0.2%)	0.93	(0.46- 1.88)	-0.01%	( 0.05%)
	Retina, choroid and vitreous haemorrhages and vascular disorders	28	( 0.3%)	34	( 0.3%)	0.81	(0.50- 1.34)	-0.06%	( 0.08%)
	Retinal bleeding and vascular disorders (excl retinopathy)	21	( 0.2%)	29	( 0.3%)	0.72	(0.41- 1.25)	-0.08%	( 0.07%)
	Retinopathies NEC	7	( 0.1%)	6	( 0.1%)	1.15	(0.39- 3.42)	0.01%	( 0.04%)
	Vision disorders	21	( 0.2%)	27	( 0.3%)	0.77	(0.44- 1.36)	-0.06%	( 0.07%)
	Blindness (excl colour blindness)	13	( 0.1%)	10	( 0.1%)	1.29	(0.57- 2.91)	0.03%	( 0.05%)
	Partial vision loss	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.99)	-0.00%	( 0.01%)
	Visual disorders NEC	7	( 0.1%)	16	( 0.2%)	0.45	(0.20- 1.03)	-0.09%	( 0.05%)
	Gastrointestinal disorders	610	( 5.9%)	647	( 6.3%)	0.93	(0.84- 1.04)	-0.36%	( 0.33%)
	Abdominal hernias and other abdominal wall conditions	28	( 0.3%)	49	( 0.5%)	0.57	(0.37- 0.90)	-0.20%	( 0.09%)
	Abdominal hernias, site unspecified	11	( 0.1%)	19	( 0.2%)	0.58	(0.28- 1.19)	-0.08%	( 0.05%)
	Diaphragmatic hernias	16	( 0.2%)	30	( 0.3%)	0.54	(0.30- 0.96)	-0.14%	( 0.07%)
	Femoral hernias	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.30)	0.01%	( 0.01%)
	Anal and rectal conditions NEC	8	( 0.1%)	2	( 0.0%)	3.29	(0.95- 11.36)	0.06%	( 0.03%)
	Anal and rectal disorders NEC	8	( 0.1%)	2	( 0.0%)	3.29	(0.95- 11.36)	0.06%	( 0.03%)
	Diverticular disorders	2	( 0.0%)	4	( 0.0%)	0.51	(0.10- 2.52)	-0.02%	( 0.02%)
	Diverticula	2	( 0.0%)	4	( 0.0%)	0.51	(0.10- 2.52)	-0.02%	( 0.02%)
	Exocrine pancreas conditions	34	( 0.3%)	43	( 0.4%)	0.78	(0.50- 1.23)	-0.09%	( 0.09%)
	Pancreatic disorders NEC	3	( 0.0%)	5	( 0.0%)	0.60	(0.15- 2.40)	-0.02%	( 0.03%)
	Acute and chronic pancreatitis	31	( 0.3%)	41	( 0.4%)	0.75	(0.47- 1.19)	-0.10%	( 0.08%)
	Gastrointestinal conditions NEC	71	( 0.7%)	79	( 0.8%)	0.89	(0.65- 1.23)	-0.08%	( 0.12%)
	Gastrointestinal disorders NEC	57	( 0.6%)	62	( 0.6%)	0.91	(0.64- 1.31)	-0.05%	( 0.11%)
	Gastrointestinal fistulae	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.92)	-0.01%	( 0.02%)
	Oesophageal disorders NEC	5	( 0.0%)	3	( 0.0%)	1.63	(0.41- 6.52)	0.02%	( 0.03%)
	Gastrointestinal mucosal dystrophies and secretion disorders	10	( 0.1%)	12	( 0.1%)	0.83	(0.36- 1.91)	-0.02%	( 0.05%)
	Gastrointestinal haemorrhages NEC	133	( 1.3%)	106	( 1.0%)	1.24	(0.97- 1.60)	0.26%	( 0.15%)
	Gastric and oesophageal haemorrhages	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.13)	-0.02%	( 0.01%)
	Non-site specific gastrointestinal haemorrhages	83	( 0.8%)	70	( 0.7%)	1.18	(0.86- 1.61)	0.13%	( 0.12%)
	Intestinal haemorrhages	53	( 0.5%)	35	( 0.3%)	1.49	(0.98- 2.27)	0.18%	( 0.09%)
	Gastrointestinal inflammatory conditions	52	( 0.5%)	50	( 0.5%)	1.03	(0.70- 1.52)	0.02%	( 0.10%)
	Colitis (excl infective)	28	( 0.3%)	17	( 0.2%)	1.62	(0.90- 2.90)	0.11%	( 0.07%)
	Gastritis (excl infective)	12	( 0.1%)	20	( 0.2%)	0.60	(0.30- 1.20)	-0.08%	( 0.06%)
	Gastrointestinal inflammatory disorders NEC	8	( 0.1%)	10	( 0.1%)	0.79	(0.31- 1.99)	-0.02%	( 0.04%)
	Oesophagitis (excl infective)	4	( 0.0%)	4	( 0.0%)	0.99	(0.25- 3.96)	-0.00%	( 0.03%)
	Gastrointestinal motility and defaecation conditions	41	( 0.4%)	57	( 0.6%)	0.72	(0.48- 1.06)	-0.16%	( 0.10%)
	Diarrhoea (excl infective)	15	( 0.1%)	23	( 0.2%)	0.65	(0.34- 1.23)	-0.08%	( 0.06%)
	Gastrointestinal atonic and hypomotility disorders NEC	23	( 0.2%)	28	( 0.3%)	0.81	(0.47- 1.41)	-0.05%	( 0.07%)
	Gastrointestinal dyskinetic disorders	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.92)	-0.00%	( 0.01%)
	Gastrointestinal spastic and hypermotility disorders	2	( 0.0%)	5	( 0.0%)	0.42	(0.10- 1.85)	-0.03%	( 0.03%)
	Malignant and unspecified neoplasms gastrointestinal NEC	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.75)	-0.01%	( 0.01%)
	Pancreatic neoplasms	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.75)	-0.01%	( 0.01%)
	Gastrointestinal stenosis and obstruction	22	( 0.2%)	29	( 0.3%)	0.75	(0.43- 1.30)	-0.07%	( 0.07%)
	Gastrointestinal stenosis and obstruction NEC	18	( 0.2%)	18	( 0.2%)	0.99	(0.52- 1.91)	-0.00%	( 0.06%)
	Large intestinal stenosis and obstruction	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.73)	-0.01%	( 0.01%)
	Oesophageal stenosis and obstruction	4	( 0.0%)	10	( 0.1%)	0.42	(0.15- 1.20)	-0.06%	( 0.04%)
	Gastrointestinal signs and symptoms	145	( 1.4%)	150	( 1.5%)	0.96	(0.76- 1.20)	-0.05%	( 0.17%)
	Dyspeptic signs and symptoms	14	( 0.1%)	12	( 0.1%)	1.16	(0.54- 2.50)	0.02%	( 0.05%)
	Flatulence, bloating and distension	3	( 0.0%)	5	( 0.0%)	0.60	(0.15- 2.42)	-0.02%	( 0.03%)
	Gastrointestinal and abdominal pains (excl oral and throat)	100	( 1.0%)	105	( 1.0%)	0.94	(0.72- 1.24)	-0.05%	( 0.14%)
	Gastrointestinal signs and symptoms NEC	5	( 0.0%)	6	( 0.1%)	0.83	(0.25- 2.69)	-0.01%	( 0.03%)
	Nausea and vomiting symptoms	23	( 0.2%)	26	( 0.3%)	0.88	(0.50- 1.54)	-0.03%	( 0.07%)
	Gastrointestinal ulceration and perforation	102	( 1.0%)	93	( 0.9%)	1.09	(0.82- 1.44)	0.09%	( 0.14%)
	Duodenal ulcers and perforation	27	( 0.3%)	25	( 0.2%)	1.07	(0.62- 1.85)	0.02%	( 0.07%)
	Gastric ulcers and perforation	45	( 0.4%)	37	( 0.4%)	1.21	(0.78- 1.86)	0.08%	( 0.09%)
	Oesophageal ulcers and perforation	2	( 0.0%)	0	( 0.0%)	7.36	(0.46-117.69)	0.02%	( 0.01%)
	Intestinal ulcers and perforation NEC	1	( 0.0%)	3	( 0.0%)	0.36	(0.05- 2.59)	-0.02%	( 0.02%)
	Peptic ulcers and perforation	27	( 0.3%)	30	( 0.3%)	0.89	(0.53- 1.50)	-0.03%	( 0.07%)
	Gastrointestinal vascular conditions	16	( 0.2%)	16	( 0.2%)	0.99	(0.50- 1.99)	-0.00%	( 0.06%)
	Gastrointestinal vascular occlusion and infarction	7	( 0.1%)	11	( 0.1%)	0.64	(0.25- 1.60)	-0.04%	( 0.04%)
	Haemorrhoids and gastrointestinal varices (excl oesophageal)	5	( 0.0%)	5	( 0.0%)	0.99	(0.29- 3.44)	-0.00%	( 0.03%)
	Oesophageal varices	4	( 0.0%)	0	( 0.0%)	7.36	(1.04- 52.22)	0.04%	( 0.02%)
	Malabsorption conditions	4	( 0.0%)	2	( 0.0%)	1.93	(0.39- 9.57)	0.02%	( 0.02%)
	Malabsorption syndromes	4	( 0.0%)	2	( 0.0%)	1.93	(0.39- 9.57)	0.02%	( 0.02%)
	Oral soft tissue conditions	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.15)	-0.02%	( 0.01%)
	Oral soft tissue disorders NEC	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.15)	-0.02%	( 0.01%)
	Peritoneal and retroperitoneal conditions	13	( 0.1%)	17	( 0.2%)	0.76	(0.37- 1.55)	-0.04%	( 0.05%)
	Peritoneal and retroperitoneal disorders	8	( 0.1%)	13	( 0.1%)	0.62	(0.26- 1.45)	-0.05%	( 0.04%)
	Peritoneal and retroperitoneal fibrosis and adhesions	5	( 0.0%)	4	( 0.0%)	1.24	(0.33- 4.56)	0.01%	( 0.03%)
	Salivary gland conditions	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.84)	-0.01%	( 0.02%)
	Salivary gland disorders NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.84)	-0.01%	( 0.02%)
	Tongue conditions	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.79)	-0.01%	( 0.01%)
	Tongue disorders	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.79)	-0.01%	( 0.01%)
	Dental and gingival conditions	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.74)	-0.01%	( 0.01%)
	Dental disorders NEC	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.74)	-0.01%	( 0.01%)
	General disorders and administration site conditions	449	( 4.4%)	474	( 4.6%)	0.94	(0.83- 1.07)	-0.24%	( 0.29%)
	Body temperature conditions	4	( 0.0%)	12	( 0.1%)	0.36	(0.14- 0.97)	-0.08%	( 0.04%)
	Febrile disorders	4	( 0.0%)	12	( 0.1%)	0.36	(0.14- 0.97)	-0.08%	( 0.04%)
	General system disorders NEC	273	( 2.7%)	292	( 2.8%)	0.93	(0.79- 1.09)	-0.19%	( 0.23%)
	Asthenic conditions	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.59)	-0.02%	( 0.02%)
	General signs and symptoms NEC	19	( 0.2%)	19	( 0.2%)	0.99	(0.52- 1.87)	-0.00%	( 0.06%)
	Hernias NEC	4	( 0.0%)	3	( 0.0%)	1.32	(0.30- 5.81)	0.01%	( 0.03%)
	Oedema NEC	18	( 0.2%)	25	( 0.2%)	0.72	(0.39- 1.30)	-0.07%	( 0.06%)
	Pain and discomfort NEC	235	( 2.3%)	243	( 2.4%)	0.96	(0.80- 1.15)	-0.08%	( 0.21%)
	Fatal outcomes	156	( 1.5%)	160	( 1.6%)	0.97	(0.78- 1.21)	-0.04%	( 0.17%)
	Death and sudden death	156	( 1.5%)	160	( 1.6%)	0.97	(0.78- 1.21)	-0.04%	( 0.17%)
	Therapeutic and nontherapeutic effects (excl toxicity)	23	( 0.2%)	19	( 0.2%)	1.20	(0.66- 2.20)	0.04%	( 0.06%)
	Therapeutic and nontherapeutic responses	23	( 0.2%)	19	( 0.2%)	1.20	(0.66- 2.20)	0.04%	( 0.06%)
	Product quality issues	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.76)	-0.01%	( 0.01%)
	Product physical issues	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.76)	-0.01%	( 0.01%)
	Hepatobiliary disorders	118	( 1.1%)	102	( 1.0%)	1.15	(0.88- 1.50)	0.16%	( 0.14%)
	Bile duct disorders	3	( 0.0%)	6	( 0.1%)	0.51	(0.14- 1.88)	-0.03%	( 0.03%)
	Bile duct infections and inflammations	2	( 0.0%)	5	( 0.0%)	0.42	(0.10- 1.85)	-0.03%	( 0.03%)
	Structural and other bile duct disorders	1	( 0.0%)	1	( 0.0%)	0.98	(0.06- 15.73)	-0.00%	( 0.01%)
	Gallbladder disorders	88	( 0.9%)	74	( 0.7%)	1.18	(0.87- 1.61)	0.14%	( 0.12%)
	Cholecystitis and cholelithiasis	86	( 0.8%)	72	( 0.7%)	1.19	(0.87- 1.62)	0.14%	( 0.12%)
	Gallbladder disorders NEC	5	( 0.0%)	2	( 0.0%)	2.35	(0.53- 10.33)	0.03%	( 0.03%)
	Hepatic and hepatobiliary disorders	31	( 0.3%)	28	( 0.3%)	1.10	(0.66- 1.83)	0.03%	( 0.07%)
	Cholestasis and jaundice	9	( 0.1%)	13	( 0.1%)	0.69	(0.30- 1.59)	-0.04%	( 0.05%)
	Hepatic failure and associated disorders	2	( 0.0%)	0	( 0.0%)	7.34	(0.46-117.34)	0.02%	( 0.01%)
	Hepatic fibrosis and cirrhosis	6	( 0.1%)	4	( 0.0%)	1.48	(0.43- 5.11)	0.02%	( 0.03%)
	Hepatocellular damage and hepatitis NEC	8	( 0.1%)	6	( 0.1%)	1.32	(0.46- 3.76)	0.02%	( 0.04%)
	Hepatic and hepatobiliary disorders NEC	10	( 0.1%)	6	( 0.1%)	1.64	(0.62- 4.37)	0.04%	( 0.04%)
	Immune system disorders	17	( 0.2%)	16	( 0.2%)	1.05	(0.53- 2.09)	0.01%	( 0.06%)
	Allergic conditions	12	( 0.1%)	14	( 0.1%)	0.85	(0.39- 1.83)	-0.02%	( 0.05%)
	Allergies to foods, food additives, drugs and other chemicals	6	( 0.1%)	6	( 0.1%)	0.99	(0.32- 3.07)	-0.00%	( 0.03%)
	Anaphylactic responses	3	( 0.0%)	3	( 0.0%)	0.99	(0.20- 4.92)	-0.00%	( 0.02%)
	Allergic conditions NEC	3	( 0.0%)	5	( 0.0%)	0.60	(0.15- 2.40)	-0.02%	( 0.03%)
	Immune disorders NEC	5	( 0.0%)	2	( 0.0%)	2.34	(0.53- 10.29)	0.03%	( 0.03%)
	Acute and chronic sarcoidosis	3	( 0.0%)	2	( 0.0%)	1.48	(0.26- 8.55)	0.01%	( 0.02%)
	Vasculitides	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.28)	0.01%	( 0.01%)
	Transplant rejections	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.44)	0.01%	( 0.01%)
	Infections and infestations	963	( 9.4%)	1037	(10.1%)	0.92	(0.84- 1.00)	-0.72%	( 0.41%)
	Bacterial infectious disorders	34	( 0.3%)	34	( 0.3%)	0.99	(0.62- 1.59)	-0.00%	( 0.08%)
	Bacterial infections NEC	22	( 0.2%)	17	( 0.2%)	1.28	(0.68- 2.40)	0.05%	( 0.06%)
	Clostridia infections	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.71)	-0.01%	( 0.01%)
	Helicobacter infections	2	( 0.0%)	0	( 0.0%)	7.34	(0.46-117.35)	0.02%	( 0.01%)
	Legionella infections	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.87)	-0.01%	( 0.02%)
	Pseudomonal infections	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.72)	-0.01%	( 0.01%)
	Salmonella infections	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.76)	-0.00%	( 0.01%)
	Staphylococcal infections	6	( 0.1%)	8	( 0.1%)	0.74	(0.26- 2.12)	-0.02%	( 0.04%)
	Streptococcal infections	2	( 0.0%)	4	( 0.0%)	0.51	(0.10- 2.52)	-0.02%	( 0.02%)
	Fungal infectious disorders	4	( 0.0%)	2	( 0.0%)	1.94	(0.39- 9.59)	0.02%	( 0.02%)
	Aspergillus infections	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.36)	0.01%	( 0.01%)
	Fungal infections NEC	3	( 0.0%)	2	( 0.0%)	1.48	(0.26- 8.56)	0.01%	( 0.02%)
	Infections - pathogen unspecified	873	( 8.5%)	956	( 9.3%)	0.90	(0.82- 0.99)	-0.81%	( 0.40%)
	Bone and joint infections	14	( 0.1%)	18	( 0.2%)	0.77	(0.39- 1.54)	-0.04%	( 0.06%)
	Breast infections	4	( 0.0%)	1	( 0.0%)	3.29	(0.57- 19.01)	0.03%	( 0.02%)
	Cardiac infections	5	( 0.0%)	4	( 0.0%)	1.24	(0.34- 4.58)	0.01%	( 0.03%)
	Central nervous system and spinal infections	3	( 0.0%)	6	( 0.1%)	0.51	(0.14- 1.88)	-0.03%	( 0.03%)
	Dental and oral soft tissue infections	4	( 0.0%)	2	( 0.0%)	1.94	(0.39- 9.62)	0.02%	( 0.02%)
	Ear infections	12	( 0.1%)	11	( 0.1%)	1.08	(0.48- 2.45)	0.01%	( 0.05%)
	Eye and eyelid infections	6	( 0.1%)	9	( 0.1%)	0.66	(0.24- 1.83)	-0.03%	( 0.04%)
	Abdominal and gastrointestinal infections	107	( 1.0%)	130	( 1.3%)	0.82	(0.63- 1.05)	-0.22%	( 0.15%)
	Infections NEC	43	( 0.4%)	48	( 0.5%)	0.89	(0.59- 1.34)	-0.05%	( 0.09%)
	Lower respiratory tract and lung infections	515	( 5.0%)	513	( 5.0%)	1.00	(0.88- 1.13)	0.02%	( 0.30%)
	Male reproductive tract infections M	8	( 0.1%)	14	( 0.2%)	0.57	(0.25- 1.33)	-0.08%	( 0.06%)
	Sepsis, bacteraemia, viraemia and fungaemia NEC	30	( 0.3%)	62	( 0.6%)	0.49	(0.33- 0.74)	-0.31%	( 0.09%)
	Skin structures and soft tissue infections	103	( 1.0%)	123	( 1.2%)	0.83	(0.64- 1.08)	-0.19%	( 0.15%)
	Upper respiratory tract infections	6	( 0.1%)	4	( 0.0%)	1.48	(0.43- 5.12)	0.02%	( 0.03%)
	Urinary tract infections	87	( 0.8%)	90	( 0.9%)	0.96	(0.71- 1.29)	-0.03%	( 0.13%)
	Hepatobiliary and spleen infections	1	( 0.0%)	4	( 0.0%)	0.30	(0.05- 1.72)	-0.03%	( 0.02%)
	Mycobacterial infectious disorders	5	( 0.0%)	7	( 0.1%)	0.71	(0.23- 2.20)	-0.02%	( 0.03%)
	Tuberculous infections	5	( 0.0%)	7	( 0.1%)	0.71	(0.23- 2.20)	-0.02%	( 0.03%)
	Protozoal infectious disorders	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.93)	-0.00%	( 0.01%)
	Plasmodia infections	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.93)	-0.00%	( 0.01%)
	Viral infectious disorders	73	( 0.7%)	80	( 0.8%)	0.90	(0.66- 1.24)	-0.07%	( 0.12%)
	Epstein-Barr viral infections	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.71)	-0.01%	( 0.01%)
	Herpes viral infections	18	( 0.2%)	19	( 0.2%)	0.94	(0.49- 1.79)	-0.01%	( 0.06%)
	Influenza viral infections	11	( 0.1%)	11	( 0.1%)	0.99	(0.43- 2.28)	-0.00%	( 0.05%)
	Prion-associated disorders	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.84)	-0.00%	( 0.01%)
	Viral infections NEC	44	( 0.4%)	48	( 0.5%)	0.91	(0.60- 1.37)	-0.04%	( 0.09%)
	Injury, poisoning and procedural complications	583	( 5.7%)	668	( 6.5%)	0.86	(0.77- 0.96)	-0.83%	( 0.33%)
	Bone and joint injuries	257	( 2.5%)	256	( 2.5%)	1.00	(0.84- 1.18)	0.01%	( 0.22%)
	Lower limb fractures and dislocations	128	( 1.2%)	132	( 1.3%)	0.96	(0.75- 1.23)	-0.04%	( 0.16%)
	Fractures and dislocations NEC	11	( 0.1%)	25	( 0.2%)	0.46	(0.24- 0.88)	-0.14%	( 0.06%)
	Limb injuries NEC (incl traumatic amputation)	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.15)	-0.02%	( 0.01%)
	Pelvic fractures and dislocations	5	( 0.0%)	12	( 0.1%)	0.43	(0.17- 1.12)	-0.07%	( 0.04%)
	Skull fractures, facial bone fractures and dislocations	5	( 0.0%)	3	( 0.0%)	1.62	(0.40- 6.48)	0.02%	( 0.03%)
	Spinal fractures and dislocations	12	( 0.1%)	13	( 0.1%)	0.92	(0.42- 2.01)	-0.01%	( 0.05%)
	Thoracic cage fractures and dislocations	24	( 0.2%)	17	( 0.2%)	1.40	(0.76- 2.58)	0.07%	( 0.06%)
	Upper limb fractures and dislocations	82	( 0.8%)	66	( 0.6%)	1.23	(0.89- 1.70)	0.16%	( 0.12%)
	Injuries NEC	262	( 2.6%)	319	( 3.1%)	0.81	(0.69- 0.96)	-0.56%	( 0.23%)
	Cardiovascular injuries	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.41)	0.01%	( 0.01%)
	Abdominal injuries NEC	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.72)	-0.01%	( 0.01%)
	Chest and lung injuries NEC	12	( 0.1%)	13	( 0.1%)	0.92	(0.42- 2.01)	-0.01%	( 0.05%)
	Eye injuries NEC	2	( 0.0%)	0	( 0.0%)	7.36	(0.46-117.60)	0.02%	( 0.01%)
	Muscle, tendon and ligament injuries	7	( 0.1%)	10	( 0.1%)	0.70	(0.27- 1.81)	-0.03%	( 0.04%)
	Non-site specific injuries NEC	213	( 2.1%)	266	( 2.6%)	0.79	(0.66- 0.95)	-0.52%	( 0.21%)
	Site specific injuries NEC	18	( 0.2%)	21	( 0.2%)	0.85	(0.45- 1.59)	-0.03%	( 0.06%)
	Cerebral injuries NEC	10	( 0.1%)	11	( 0.1%)	0.90	(0.38- 2.12)	-0.01%	( 0.04%)
	Injuries by physical agents	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.96)	-0.00%	( 0.02%)
	Conditions caused by cold	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.02%	( 0.01%)
	Heat injuries (excl thermal burns)	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.32)	0.02%	( 0.02%)
	Medication errors	4	( 0.0%)	2	( 0.0%)	1.93	(0.39- 9.58)	0.02%	( 0.02%)
	Overdoses	4	( 0.0%)	2	( 0.0%)	1.93	(0.39- 9.58)	0.02%	( 0.02%)
	Chemical injury and poisoning	6	( 0.1%)	4	( 0.0%)	1.48	(0.43- 5.12)	0.02%	( 0.03%)
	Chemical injuries	4	( 0.0%)	1	( 0.0%)	3.31	(0.57- 19.13)	0.03%	( 0.02%)
	Poisoning and toxicity	2	( 0.0%)	3	( 0.0%)	0.66	(0.11- 3.82)	-0.01%	( 0.02%)
	Procedural related injuries and complications NEC	78	( 0.8%)	116	( 1.1%)	0.67	(0.50- 0.89)	-0.37%	( 0.13%)
	Cardiac and vascular procedural complications	9	( 0.1%)	9	( 0.1%)	0.99	(0.39- 2.50)	-0.00%	( 0.04%)
	Gastrointestinal and hepatobiliary procedural complications	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.80)	-0.01%	( 0.01%)
	Non-site specific procedural complications	69	( 0.7%)	104	( 1.0%)	0.66	(0.49- 0.89)	-0.34%	( 0.13%)
	Respiratory tract and thoracic cavity procedural complications	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.60)	-0.02%	( 0.02%)
	Investigations	1559	(15.2%)	1692	(16.5%)	0.91	(0.85- 0.97)	-1.30%	( 0.51%)
	Cardiac and vascular investigations (excl enzyme tests)	760	( 7.4%)	895	( 8.7%)	0.84	(0.76- 0.92)	-1.32%	( 0.38%)
	Cardiac function diagnostic procedures	59	( 0.6%)	58	( 0.6%)	1.01	(0.70- 1.45)	0.01%	( 0.11%)
	Cardiac imaging procedures	518	( 5.0%)	624	( 6.1%)	0.82	(0.73- 0.92)	-1.03%	( 0.32%)
	Vascular and lymphatic histopathology procedures	2	( 0.0%)	5	( 0.0%)	0.42	(0.10- 1.85)	-0.03%	( 0.03%)
	Vascular imaging procedures NEC	215	( 2.1%)	251	( 2.4%)	0.85	(0.71- 1.02)	-0.35%	( 0.21%)
	Vascular tests NEC (incl blood pressure)	5	( 0.0%)	0	( 0.0%)	7.37	(1.28- 42.56)	0.05%	( 0.02%)
	Endocrine investigations (incl sex hormones)	5	( 0.0%)	3	( 0.0%)	1.64	(0.41- 6.56)	0.02%	( 0.03%)
	Endocrine analyses and imaging NEC	5	( 0.0%)	3	( 0.0%)	1.64	(0.41- 6.56)	0.02%	( 0.03%)
	Gastrointestinal investigations	382	( 3.7%)	386	( 3.8%)	0.98	(0.85- 1.13)	-0.04%	( 0.26%)
	Gastrointestinal and abdominal imaging procedures	382	( 3.7%)	386	( 3.8%)	0.98	(0.85- 1.13)	-0.04%	( 0.26%)
	Haematology investigations (incl blood groups)	20	( 0.2%)	16	( 0.2%)	1.24	(0.64- 2.38)	0.04%	( 0.06%)
	Coagulation and bleeding analyses	2	( 0.0%)	0	( 0.0%)	7.33	(0.46-117.18)	0.02%	( 0.01%)
	Haematological analyses NEC	11	( 0.1%)	9	( 0.1%)	1.21	(0.50- 2.91)	0.02%	( 0.04%)
	Bone marrow and immune tissue histopathology procedures	7	( 0.1%)	7	( 0.1%)	0.99	(0.35- 2.82)	-0.00%	( 0.04%)
	Hepatobiliary investigations	21	( 0.2%)	22	( 0.2%)	0.95	(0.52- 1.72)	-0.01%	( 0.06%)
	Hepatobiliary histopathology procedures	4	( 0.0%)	6	( 0.1%)	0.66	(0.19- 2.29)	-0.02%	( 0.03%)
	Hepatobiliary imaging procedures	17	( 0.2%)	15	( 0.1%)	1.13	(0.56- 2.25)	0.02%	( 0.06%)
	Liver function analyses	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.99)	-0.00%	( 0.01%)
	Investigations, imaging and histopathology procedures NEC	175	( 1.7%)	173	( 1.7%)	1.00	(0.81- 1.24)	0.02%	( 0.18%)
	Histopathology procedures NEC	11	( 0.1%)	6	( 0.1%)	1.79	(0.69- 4.62)	0.05%	( 0.04%)
	Imaging procedures NEC	24	( 0.2%)	27	( 0.3%)	0.88	(0.51- 1.53)	-0.03%	( 0.07%)
	Investigations NEC	142	( 1.4%)	141	( 1.4%)	1.00	(0.79- 1.26)	0.01%	( 0.16%)
	Musculoskeletal and soft tissue investigations (excl enzyme tests)	35	( 0.3%)	34	( 0.3%)	1.02	(0.64- 1.64)	0.01%	( 0.08%)
	Musculoskeletal and soft tissue histopathology procedures	8	( 0.1%)	7	( 0.1%)	1.14	(0.41- 3.13)	0.01%	( 0.04%)
	Musculoskeletal and soft tissue imaging procedures	27	( 0.3%)	27	( 0.3%)	0.99	(0.58- 1.69)	-0.00%	( 0.07%)
	Neurological, special senses and psychiatric investigations	15	( 0.1%)	13	( 0.1%)	1.14	(0.55- 2.40)	0.02%	( 0.05%)
	Central nervous system imaging procedures	4	( 0.0%)	3	( 0.0%)	1.32	(0.30- 5.82)	0.01%	( 0.03%)
	Neurologic diagnostic procedures	9	( 0.1%)	10	( 0.1%)	0.89	(0.36- 2.19)	-0.01%	( 0.04%)
	Peripheral nervous system histopathology procedures	1	( 0.0%)	0	( 0.0%)	7.34	(0.15-369.79)	0.01%	( 0.01%)
	Psychiatric investigations	1	( 0.0%)	0	( 0.0%)	7.30	(0.14-368.02)	0.01%	( 0.01%)
	Renal and urinary tract investigations and urinalyses	165	( 1.6%)	184	( 1.8%)	0.89	(0.72- 1.10)	-0.19%	( 0.18%)
	Urinary tract histopathology procedures	14	( 0.1%)	18	( 0.2%)	0.77	(0.39- 1.54)	-0.04%	( 0.06%)
	Urinary tract imaging procedures	157	( 1.5%)	169	( 1.6%)	0.92	(0.74- 1.14)	-0.12%	( 0.17%)
	Reproductive organ and breast investigations (excl hormone analyses)	55	( 0.5%)	49	( 0.5%)	1.11	(0.76- 1.64)	0.06%	( 0.10%)
	Reproductive organ and breast histopathology procedures	46	( 0.4%)	38	( 0.4%)	1.20	(0.78- 1.84)	0.08%	( 0.09%)
	Reproductive organ and breast imaging procedures F	9	( 0.4%)	12	( 0.5%)	0.75	(0.32- 1.76)	-0.12%	( 0.18%)
	Respiratory and pulmonary investigations (excl blood gases)	80	( 0.8%)	70	( 0.7%)	1.13	(0.82- 1.56)	0.10%	( 0.12%)
	Respiratory tract and thoracic histopathology procedures	29	( 0.3%)	24	( 0.2%)	1.20	(0.70- 2.05)	0.05%	( 0.07%)
	Respiratory tract and thoracic imaging procedures	52	( 0.5%)	38	( 0.4%)	1.35	(0.90- 2.05)	0.14%	( 0.09%)
	Respiratory and pulmonary function diagnostic procedures	6	( 0.1%)	9	( 0.1%)	0.66	(0.24- 1.83)	-0.03%	( 0.04%)
	Skin investigations	14	( 0.1%)	14	( 0.1%)	0.99	(0.47- 2.08)	-0.00%	( 0.05%)
	Skin histopathology procedures	14	( 0.1%)	14	( 0.1%)	0.99	(0.47- 2.08)	-0.00%	( 0.05%)
	Toxicology and therapeutic drug monitoring	4	( 0.0%)	2	( 0.0%)	1.93	(0.39- 9.55)	0.02%	( 0.02%)
	Therapeutic drug monitoring analyses	4	( 0.0%)	2	( 0.0%)	1.93	(0.39- 9.55)	0.02%	( 0.02%)
	Physical examination topics	29	( 0.3%)	25	( 0.2%)	1.15	(0.68- 1.96)	0.04%	( 0.07%)
	Physical examination procedures	29	( 0.3%)	25	( 0.2%)	1.15	(0.68- 1.96)	0.04%	( 0.07%)
	Metabolism and nutrition disorders	400	( 3.9%)	405	( 3.9%)	0.98	(0.85- 1.12)	-0.05%	( 0.27%)
	Acid-base disorders	1	( 0.0%)	0	( 0.0%)	7.30	(0.14-367.87)	0.01%	( 0.01%)
	Mixed acid-base disorders	1	( 0.0%)	0	( 0.0%)	7.30	(0.14-367.87)	0.01%	( 0.01%)
	Appetite and general nutritional disorders	9	( 0.1%)	7	( 0.1%)	1.27	(0.48- 3.40)	0.02%	( 0.04%)
	Appetite disorders	4	( 0.0%)	0	( 0.0%)	7.35	(1.04- 52.20)	0.04%	( 0.02%)
	General nutritional disorders NEC	6	( 0.1%)	7	( 0.1%)	0.85	(0.29- 2.52)	-0.01%	( 0.04%)
	Diabetic complications	12	( 0.1%)	23	( 0.2%)	0.53	(0.27- 1.03)	-0.11%	( 0.06%)
	Diabetic complications NEC	12	( 0.1%)	23	( 0.2%)	0.53	(0.27- 1.03)	-0.11%	( 0.06%)
	Bone, calcium, magnesium and phosphorus metabolism disorders	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.15)	-0.02%	( 0.01%)
	Calcium metabolism disorders	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.15)	-0.02%	( 0.01%)
	Electrolyte and fluid balance conditions	25	( 0.2%)	24	( 0.2%)	1.03	(0.59- 1.81)	0.01%	( 0.07%)
	Electrolyte imbalance NEC	3	( 0.0%)	4	( 0.0%)	0.75	(0.17- 3.28)	-0.01%	( 0.03%)
	Potassium imbalance	10	( 0.1%)	4	( 0.0%)	2.33	(0.82- 6.65)	0.06%	( 0.04%)
	Sodium imbalance	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.80)	-0.01%	( 0.01%)
	Total fluid volume decreased	8	( 0.1%)	11	( 0.1%)	0.72	(0.29- 1.78)	-0.03%	( 0.04%)
	Total fluid volume increased	4	( 0.0%)	4	( 0.0%)	0.99	(0.25- 3.95)	-0.00%	( 0.03%)
	Glucose metabolism disorders (incl diabetes mellitus)	356	( 3.5%)	348	( 3.4%)	1.01	(0.88- 1.18)	0.08%	( 0.25%)
	Diabetes mellitus (incl subtypes)	313	( 3.0%)	301	( 2.9%)	1.03	(0.88- 1.21)	0.12%	( 0.24%)
	Hypoglycaemic conditions NEC	53	( 0.5%)	54	( 0.5%)	0.97	(0.67- 1.42)	-0.01%	( 0.10%)
	Purine and pyrimidine metabolism disorders	10	( 0.1%)	13	( 0.1%)	0.76	(0.34- 1.73)	-0.03%	( 0.05%)
	Disorders of purine metabolism	10	( 0.1%)	13	( 0.1%)	0.76	(0.34- 1.73)	-0.03%	( 0.05%)
	Vitamin related disorders	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.90)	0.01%	( 0.01%)
	Water soluble vitamin deficiencies	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.90)	0.01%	( 0.01%)
	Musculoskeletal and connective tissue disorders	175	( 1.7%)	190	( 1.9%)	0.91	(0.74- 1.12)	-0.15%	( 0.18%)
	Bone disorders (excl congenital and fractures)	14	( 0.1%)	15	( 0.1%)	0.92	(0.45- 1.91)	-0.01%	( 0.05%)
	Metabolic bone disorders	8	( 0.1%)	9	( 0.1%)	0.88	(0.34- 2.27)	-0.01%	( 0.04%)
	Bone disorders NEC	6	( 0.1%)	6	( 0.1%)	0.99	(0.32- 3.07)	-0.00%	( 0.03%)
	Connective tissue disorders (excl congenital)	7	( 0.1%)	13	( 0.1%)	0.54	(0.23- 1.31)	-0.06%	( 0.04%)
	Connective tissue disorders (excl LE)	7	( 0.1%)	9	( 0.1%)	0.77	(0.29- 2.06)	-0.02%	( 0.04%)
	Lupus erythematosus (incl subtypes)	0	( 0.0%)	4	( 0.0%)	0.13	(0.02- 0.95)	-0.04%	( 0.02%)
	Synovial and bursal disorders	7	( 0.1%)	9	( 0.1%)	0.77	(0.29- 2.06)	-0.02%	( 0.04%)
	Bursal disorders	2	( 0.0%)	6	( 0.1%)	0.36	(0.09- 1.46)	-0.04%	( 0.03%)
	Synovial disorders	5	( 0.0%)	3	( 0.0%)	1.64	(0.41- 6.55)	0.02%	( 0.03%)
	Joint disorders	58	( 0.6%)	71	( 0.7%)	0.81	(0.57- 1.15)	-0.13%	( 0.11%)
	Arthropathies NEC	22	( 0.2%)	34	( 0.3%)	0.65	(0.38- 1.09)	-0.12%	( 0.07%)
	Joint related signs and symptoms	16	( 0.2%)	9	( 0.1%)	1.74	(0.79- 3.80)	0.07%	( 0.05%)
	Rheumatoid arthropathies	11	( 0.1%)	17	( 0.2%)	0.65	(0.31- 1.36)	-0.06%	( 0.05%)
	Spondyloarthropathies	2	( 0.0%)	0	( 0.0%)	7.35	(0.46-117.45)	0.02%	( 0.01%)
	Osteoarthropathies	8	( 0.1%)	13	( 0.1%)	0.62	(0.26- 1.45)	-0.05%	( 0.04%)
	Muscle disorders	35	( 0.3%)	26	( 0.3%)	1.33	(0.81- 2.20)	0.09%	( 0.08%)
	Muscle infections and inflammations	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.78)	-0.01%	( 0.01%)
	Muscle pains	16	( 0.2%)	14	( 0.1%)	1.13	(0.55- 2.32)	0.02%	( 0.05%)
	Muscle related signs and symptoms NEC	2	( 0.0%)	4	( 0.0%)	0.51	(0.10- 2.52)	-0.02%	( 0.02%)
	Myopathies	11	( 0.1%)	4	( 0.0%)	2.52	(0.92- 6.94)	0.07%	( 0.04%)
	Muscle weakness conditions	6	( 0.1%)	3	( 0.0%)	1.94	(0.52- 7.15)	0.03%	( 0.03%)
	Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)	15	( 0.1%)	16	( 0.2%)	0.93	(0.46- 1.88)	-0.01%	( 0.05%)
	Spine and neck deformities	6	( 0.1%)	6	( 0.1%)	0.99	(0.32- 3.08)	-0.00%	( 0.03%)
	Intervertebral disc disorders NEC	9	( 0.1%)	10	( 0.1%)	0.89	(0.36- 2.19)	-0.01%	( 0.04%)
	Musculoskeletal and connective tissue disorders NEC	47	( 0.5%)	52	( 0.5%)	0.90	(0.61- 1.33)	-0.05%	( 0.10%)
	Musculoskeletal and connective tissue signs and symptoms NEC	2	( 0.0%)	3	( 0.0%)	0.66	(0.11- 3.83)	-0.01%	( 0.02%)
	Musculoskeletal and connective tissue infections and inflammations NEC	10	( 0.1%)	6	( 0.1%)	1.64	(0.61- 4.37)	0.04%	( 0.04%)
	Musculoskeletal and connective tissue pain and discomfort	36	( 0.4%)	43	( 0.4%)	0.83	(0.53- 1.29)	-0.07%	( 0.09%)
	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	1134	(11.0%)	1093	(10.6%)	1.03	(0.95- 1.12)	0.40%	( 0.43%)
	Breast neoplasms malignant and unspecified (incl nipple)	40	( 0.4%)	53	( 0.5%)	0.75	(0.50- 1.12)	-0.13%	( 0.09%)
	Breast and nipple neoplasms malignant	40	( 0.4%)	53	( 0.5%)	0.75	(0.50- 1.12)	-0.13%	( 0.09%)
	Endocrine neoplasms benign	7	( 0.1%)	5	( 0.0%)	1.38	(0.45- 4.28)	0.02%	( 0.03%)
	Adrenal neoplasms benign	2	( 0.0%)	1	( 0.0%)	1.92	(0.20- 18.45)	0.01%	( 0.02%)
	Endocrine neoplasms benign NEC	5	( 0.0%)	4	( 0.0%)	1.24	(0.34- 4.57)	0.01%	( 0.03%)
	Endocrine neoplasms malignant and unspecified	2	( 0.0%)	0	( 0.0%)	7.35	(0.46-117.54)	0.02%	( 0.01%)
	Thyroid neoplasms malignant	2	( 0.0%)	0	( 0.0%)	7.35	(0.46-117.54)	0.02%	( 0.01%)
	Gastrointestinal neoplasms benign	22	( 0.2%)	26	( 0.3%)	0.84	(0.48- 1.48)	-0.04%	( 0.07%)
	Lip and oral cavity neoplasms benign	5	( 0.0%)	4	( 0.0%)	1.24	(0.33- 4.57)	0.01%	( 0.03%)
	Lower gastrointestinal neoplasms benign	17	( 0.2%)	22	( 0.2%)	0.77	(0.41- 1.44)	-0.05%	( 0.06%)
	Gastrointestinal neoplasms malignant and unspecified	228	( 2.2%)	232	( 2.3%)	0.97	(0.81- 1.17)	-0.04%	( 0.21%)
	Anal canal neoplasms malignant	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.15)	-0.02%	( 0.01%)
	Colonic neoplasms malignant	85	( 0.8%)	99	( 1.0%)	0.85	(0.64- 1.14)	-0.14%	( 0.13%)
	Colorectal and anal neoplasms malignancy unspecified	38	( 0.4%)	53	( 0.5%)	0.71	(0.47- 1.07)	-0.15%	( 0.09%)
	Gastric neoplasms malignant	40	( 0.4%)	37	( 0.4%)	1.07	(0.69- 1.68)	0.03%	( 0.09%)
	Gastrointestinal neoplasms malignant NEC	4	( 0.0%)	1	( 0.0%)	3.29	(0.57- 19.01)	0.03%	( 0.02%)
	Gastrointestinal neoplasms malignancy unspecified NEC	2	( 0.0%)	0	( 0.0%)	7.32	(0.46-117.10)	0.02%	( 0.01%)
	Lip and oral cavity neoplasms malignant	11	( 0.1%)	7	( 0.1%)	1.55	(0.61- 3.90)	0.04%	( 0.04%)
	Lip and oral cavity neoplasms malignancy unspecified	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.73)	-0.01%	( 0.01%)
	Oesophageal neoplasms malignant	31	( 0.3%)	24	( 0.2%)	1.28	(0.75- 2.17)	0.07%	( 0.07%)
	Oesophageal neoplasms malignancy unspecified	15	( 0.1%)	18	( 0.2%)	0.83	(0.42- 1.63)	-0.03%	( 0.06%)
	Pancreatic neoplasms malignant (excl islet cell and carcinoid)	28	( 0.3%)	22	( 0.2%)	1.26	(0.72- 2.20)	0.06%	( 0.07%)
	Rectal neoplasms malignant	3	( 0.0%)	1	( 0.0%)	2.70	(0.38- 19.14)	0.02%	( 0.02%)
	Salivary gland neoplasms malignant	4	( 0.0%)	1	( 0.0%)	3.28	(0.57- 18.96)	0.03%	( 0.02%)
	Small intestinal neoplasms malignant	4	( 0.0%)	1	( 0.0%)	3.28	(0.57- 18.93)	0.03%	( 0.02%)
	Haematopoietic neoplasms (excl leukaemias and lymphomas)	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.75)	-0.00%	( 0.01%)
	Haematologic neoplasms NEC	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.75)	-0.00%	( 0.01%)
	Hepatobiliary neoplasms malignant and unspecified	7	( 0.1%)	15	( 0.1%)	0.48	(0.21- 1.11)	-0.08%	( 0.05%)
	Bile duct neoplasms malignant	1	( 0.0%)	3	( 0.0%)	0.36	(0.05- 2.58)	-0.02%	( 0.02%)
	Gallbladder neoplasms malignant	4	( 0.0%)	7	( 0.1%)	0.58	(0.18- 1.88)	-0.03%	( 0.03%)
	Hepatic neoplasms malignant	4	( 0.0%)	6	( 0.1%)	0.66	(0.19- 2.30)	-0.02%	( 0.03%)
	Hepatobiliary neoplasms malignancy unspecified	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.02%	( 0.01%)
	Leukaemias	24	( 0.2%)	33	( 0.3%)	0.72	(0.43- 1.21)	-0.09%	( 0.07%)
	Leukaemias acute lymphocytic	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.87)	-0.00%	( 0.01%)
	Leukaemias acute myeloid	3	( 0.0%)	7	( 0.1%)	0.45	(0.13- 1.54)	-0.04%	( 0.03%)
	Leukaemias chronic lymphocytic	8	( 0.1%)	14	( 0.1%)	0.57	(0.25- 1.32)	-0.06%	( 0.05%)
	Leukaemias chronic myeloid	1	( 0.0%)	0	( 0.0%)	7.27	(0.14-366.23)	0.01%	( 0.01%)
	Leukaemias chronic NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.80)	-0.01%	( 0.01%)
	Leukaemias lymphocytic NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.01%	( 0.01%)
	Leukaemias myeloid NEC	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.37)	0.01%	( 0.01%)
	Leukaemias NEC	5	( 0.0%)	4	( 0.0%)	1.23	(0.33- 4.53)	0.01%	( 0.03%)
	Myelodysplastic syndromes	11	( 0.1%)	12	( 0.1%)	0.91	(0.40- 2.06)	-0.01%	( 0.05%)
	Lymphomas Hodgkin's disease	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.81)	-0.00%	( 0.01%)
	Hodgkin's disease NEC	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.81)	-0.00%	( 0.01%)
	Lymphomas non-Hodgkin's T-cell	1	( 0.0%)	0	( 0.0%)	7.26	(0.14-366.07)	0.01%	( 0.01%)
	Mycoses fungoides	1	( 0.0%)	0	( 0.0%)	7.26	(0.14-366.07)	0.01%	( 0.01%)
	Lymphomas non-Hodgkin's unspecified histology	29	( 0.3%)	14	( 0.1%)	1.99	(1.10- 3.62)	0.15%	( 0.06%)
	Non-Hodgkin's lymphomas NEC	29	( 0.3%)	14	( 0.1%)	1.99	(1.10- 3.62)	0.15%	( 0.06%)
	Lymphomas NEC	10	( 0.1%)	6	( 0.1%)	1.63	(0.61- 4.34)	0.04%	( 0.04%)
	Lymphomas unspecified NEC	10	( 0.1%)	6	( 0.1%)	1.63	(0.61- 4.34)	0.04%	( 0.04%)
	Mesotheliomas	10	( 0.1%)	12	( 0.1%)	0.83	(0.36- 1.91)	-0.02%	( 0.05%)
	Mesotheliomas malignant and unspecified	10	( 0.1%)	12	( 0.1%)	0.83	(0.36- 1.91)	-0.02%	( 0.05%)
	Metastases	27	( 0.3%)	36	( 0.4%)	0.75	(0.46- 1.22)	-0.09%	( 0.08%)
	Metastases to specified sites	7	( 0.1%)	8	( 0.1%)	0.87	(0.32- 2.39)	-0.01%	( 0.04%)
	Metastases to unknown and unspecified sites	20	( 0.2%)	30	( 0.3%)	0.67	(0.38- 1.16)	-0.10%	( 0.07%)
	Miscellaneous and site unspecified neoplasms malignant and unspecified	130	( 1.3%)	130	( 1.3%)	0.99	(0.78- 1.26)	-0.00%	( 0.16%)
	Neoplasms malignant site unspecified NEC	31	( 0.3%)	39	( 0.4%)	0.79	(0.49- 1.26)	-0.08%	( 0.08%)
	Neoplasms unspecified malignancy and site unspecified NEC	100	( 1.0%)	92	( 0.9%)	1.08	(0.81- 1.43)	0.08%	( 0.13%)
	Miscellaneous and site unspecified neoplasms benign	1	( 0.0%)	3	( 0.0%)	0.36	(0.05- 2.59)	-0.02%	( 0.02%)
	Aural neoplasms benign	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.76)	-0.01%	( 0.01%)
	Cardiovascular neoplasms benign	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.79)	-0.00%	( 0.01%)
	Neoplasms benign site unspecified NEC	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.78)	-0.01%	( 0.01%)
	Nervous system neoplasms benign	4	( 0.0%)	6	( 0.1%)	0.66	(0.19- 2.29)	-0.02%	( 0.03%)
	Meningiomas benign	1	( 0.0%)	0	( 0.0%)	7.37	(0.15-371.57)	0.01%	( 0.01%)
	Nervous system neoplasms benign NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.87)	-0.01%	( 0.02%)
	Neuromas	2	( 0.0%)	4	( 0.0%)	0.51	(0.10- 2.51)	-0.02%	( 0.02%)
	Nervous system neoplasms malignant and unspecified NEC	16	( 0.2%)	11	( 0.1%)	1.44	(0.68- 3.05)	0.05%	( 0.05%)
	Central nervous system neoplasms malignant NEC	12	( 0.1%)	5	( 0.0%)	2.26	(0.87- 5.85)	0.07%	( 0.04%)
	Nervous system neoplasms malignant NEC	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.77)	-0.01%	( 0.01%)
	Nervous system neoplasms unspecified malignancy NEC	6	( 0.1%)	6	( 0.1%)	0.99	(0.32- 3.07)	-0.00%	( 0.03%)
	Ocular neoplasms	4	( 0.0%)	5	( 0.0%)	0.79	(0.22- 2.93)	-0.01%	( 0.03%)
	Ocular neoplasms malignancy unspecified	4	( 0.0%)	5	( 0.0%)	0.79	(0.22- 2.93)	-0.01%	( 0.03%)
	Plasma cell neoplasms	19	( 0.2%)	10	( 0.1%)	1.84	(0.89- 3.81)	0.09%	( 0.05%)
	Multiple myelomas	15	( 0.1%)	7	( 0.1%)	2.05	(0.89- 4.72)	0.08%	( 0.05%)
	Plasma cell neoplasms NEC	4	( 0.0%)	3	( 0.0%)	1.32	(0.30- 5.79)	0.01%	( 0.03%)
	Renal and urinary tract neoplasms malignant and unspecified	102	( 1.0%)	113	( 1.1%)	0.89	(0.68- 1.17)	-0.11%	( 0.14%)
	Bladder neoplasms malignant	80	( 0.8%)	92	( 0.9%)	0.86	(0.64- 1.16)	-0.12%	( 0.13%)
	Urinary tract neoplasms malignant NEC	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.14)	-0.02%	( 0.01%)
	Urinary tract neoplasms unspecified malignancy NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.87)	-0.01%	( 0.02%)
	Renal neoplasms malignant	24	( 0.2%)	21	( 0.2%)	1.13	(0.63- 2.03)	0.03%	( 0.07%)
	Reproductive neoplasms female malignant and unspecified F	21	( 0.8%)	20	( 0.8%)	1.04	(0.57- 1.93)	0.04%	( 0.25%)
	Cervix neoplasms malignant F	2	( 0.1%)	1	( 0.0%)	1.92	(0.20- 18.46)	0.04%	( 0.07%)
	Endometrial neoplasms malignant F	9	( 0.4%)	11	( 0.4%)	0.81	(0.34- 1.96)	-0.08%	( 0.18%)
	Female reproductive neoplasms malignant NEC F	4	( 0.2%)	2	( 0.1%)	1.94	(0.39- 9.62)	0.08%	( 0.10%)
	Ovarian neoplasms malignant (excl germ cell) F	6	( 0.2%)	6	( 0.2%)	1.00	(0.32- 3.09)	-0.00%	( 0.14%)
	Uterine neoplasms malignant NEC F	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.86)	-0.00%	( 0.06%)
	Vulval neoplasms malignant F	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.67)	-0.04%	( 0.04%)
	Reproductive neoplasms female benign F	2	( 0.1%)	1	( 0.0%)	1.94	(0.20- 18.61)	0.04%	( 0.07%)
	Uterine neoplasms benign F	2	( 0.1%)	1	( 0.0%)	1.94	(0.20- 18.61)	0.04%	( 0.07%)
	Reproductive neoplasms male malignant and unspecified M	162	( 2.1%)	167	( 2.2%)	0.96	(0.77- 1.19)	-0.06%	( 0.23%)
	Penile neoplasms malignant M	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.85)	-0.01%	( 0.03%)
	Prostatic neoplasms malignant M	158	( 2.0%)	162	( 2.1%)	0.97	(0.78- 1.20)	-0.05%	( 0.23%)
	Testicular neoplasms malignant	2	( 0.0%)	2	( 0.0%)	0.99	(0.14- 7.03)	-0.00%	( 0.02%)
	Respiratory and mediastinal neoplasms malignant and unspecified	183	( 1.8%)	174	( 1.7%)	1.04	(0.85- 1.28)	0.09%	( 0.18%)
	Laryngeal neoplasms malignant	16	( 0.2%)	14	( 0.1%)	1.13	(0.55- 2.32)	0.02%	( 0.05%)
	Laryngeal neoplasms malignancy unspecified	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.90)	-0.00%	( 0.01%)
	Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecified	1	( 0.0%)	3	( 0.0%)	0.36	(0.05- 2.59)	-0.02%	( 0.02%)
	Non-small cell neoplasms malignant of the respiratory tract cell type specified	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.72)	-0.01%	( 0.01%)
	Respiratory tract and pleural neoplasms malignant cell type unspecified NEC	166	( 1.6%)	153	( 1.5%)	1.08	(0.86- 1.34)	0.13%	( 0.17%)
	Respiratory tract and pleural neoplasms malignancy unspecified NEC	120	( 1.2%)	121	( 1.2%)	0.98	(0.76- 1.26)	-0.01%	( 0.15%)
	Skeletal neoplasms malignant and unspecified	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.84)	-0.00%	( 0.01%)
	Bone neoplasms malignant (excl sarcomas)	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.81)	-0.00%	( 0.01%)
	Bone neoplasms unspecified malignancy	1	( 0.0%)	0	( 0.0%)	7.32	(0.15-368.79)	0.01%	( 0.01%)
	Cutaneous neoplasms benign	8	( 0.1%)	10	( 0.1%)	0.79	(0.32- 2.00)	-0.02%	( 0.04%)
	Skin neoplasms benign	8	( 0.1%)	10	( 0.1%)	0.79	(0.32- 2.00)	-0.02%	( 0.04%)
	Skin neoplasms malignant and unspecified	299	( 2.9%)	250	( 2.4%)	1.19	(1.01- 1.41)	0.48%	( 0.23%)
	Skin melanomas (excl ocular)	20	( 0.2%)	14	( 0.1%)	1.41	(0.72- 2.76)	0.06%	( 0.06%)
	Skin neoplasms malignant and unspecified (excl melanoma)	282	( 2.7%)	238	( 2.3%)	1.18	(0.99- 1.40)	0.43%	( 0.22%)
	Soft tissue neoplasms benign	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.82)	-0.00%	( 0.01%)
	Soft tissue neoplasms benign NEC	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.82)	-0.00%	( 0.01%)
	Soft tissue neoplasms malignant and unspecified (excl sarcomas)	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.77)	-0.01%	( 0.01%)
	Soft tissue neoplasms malignant and unspecified NEC (excl sarcomas)	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.77)	-0.01%	( 0.01%)
	Soft tissue sarcomas	6	( 0.1%)	6	( 0.1%)	0.99	(0.32- 3.07)	-0.00%	( 0.03%)
	Fibrosarcomas malignant	5	( 0.0%)	5	( 0.0%)	0.99	(0.29- 3.42)	-0.00%	( 0.03%)
	Leiomyosarcomas	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.80)	-0.00%	( 0.01%)
	Nervous system disorders	920	( 9.0%)	1090	(10.6%)	0.83	(0.76- 0.91)	-1.66%	( 0.41%)
	Central nervous system infections and inflammations	3	( 0.0%)	1	( 0.0%)	2.70	(0.38- 19.18)	0.02%	( 0.02%)
	Encephalitis NEC	3	( 0.0%)	1	( 0.0%)	2.70	(0.38- 19.18)	0.02%	( 0.02%)
	Central nervous system vascular disorders	664	( 6.5%)	853	( 8.3%)	0.77	(0.69- 0.85)	-1.84%	( 0.36%)
	Central nervous system haemorrhages and cerebrovascular accidents	419	( 4.1%)	548	( 5.3%)	0.75	(0.67- 0.86)	-1.26%	( 0.30%)
	Central nervous system vascular disorders NEC	44	( 0.4%)	63	( 0.6%)	0.70	(0.48- 1.02)	-0.19%	( 0.10%)
	Transient cerebrovascular events	268	( 2.6%)	327	( 3.2%)	0.81	(0.69- 0.95)	-0.58%	( 0.23%)
	Cranial nerve disorders (excl neoplasms)	18	( 0.2%)	7	( 0.1%)	2.39	(1.09- 5.23)	0.11%	( 0.05%)
	Cranial nerve disorders NEC	5	( 0.0%)	2	( 0.0%)	2.33	(0.53- 10.24)	0.03%	( 0.03%)
	Facial cranial nerve disorders	13	( 0.1%)	5	( 0.0%)	2.41	(0.96- 6.08)	0.08%	( 0.04%)
	Demyelinating disorders	4	( 0.0%)	3	( 0.0%)	1.32	(0.30- 5.80)	0.01%	( 0.03%)
	Multiple sclerosis acute and progressive	4	( 0.0%)	3	( 0.0%)	1.32	(0.30- 5.80)	0.01%	( 0.03%)
	Encephalopathies	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.81)	-0.00%	( 0.01%)
	Encephalopathies NEC	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.81)	-0.00%	( 0.01%)
	Headaches	20	( 0.2%)	26	( 0.3%)	0.76	(0.43- 1.36)	-0.06%	( 0.07%)
	Headaches NEC	18	( 0.2%)	24	( 0.2%)	0.75	(0.41- 1.37)	-0.06%	( 0.06%)
	Migraine headaches	3	( 0.0%)	2	( 0.0%)	1.48	(0.26- 8.54)	0.01%	( 0.02%)
	Increased intracranial pressure and hydrocephalus	5	( 0.0%)	0	( 0.0%)	7.33	(1.27- 42.32)	0.05%	( 0.02%)
	Hydrocephalic conditions	1	( 0.0%)	0	( 0.0%)	7.28	(0.14-366.81)	0.01%	( 0.01%)
	Increased intracranial pressure disorders	4	( 0.0%)	0	( 0.0%)	7.34	(1.03- 52.15)	0.04%	( 0.02%)
	Movement disorders (incl parkinsonism)	27	( 0.3%)	27	( 0.3%)	0.99	(0.58- 1.69)	-0.00%	( 0.07%)
	Dyskinesias and movement disorders NEC	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.12)	-0.02%	( 0.01%)
	Paralysis and paresis (excl cranial nerve)	2	( 0.0%)	1	( 0.0%)	1.92	(0.20- 18.49)	0.01%	( 0.02%)
	Parkinson's disease and parkinsonism	23	( 0.2%)	24	( 0.2%)	0.95	(0.54- 1.68)	-0.01%	( 0.07%)
	Tremor (excl congenital)	2	( 0.0%)	0	( 0.0%)	7.36	(0.46-117.70)	0.02%	( 0.01%)
	Neurological disorders NEC	112	( 1.1%)	118	( 1.1%)	0.94	(0.73- 1.22)	-0.06%	( 0.15%)
	Cerebellar coordination and balance disturbances	1	( 0.0%)	0	( 0.0%)	7.27	(0.14-366.37)	0.01%	( 0.01%)
	Disturbances in consciousness NEC	68	( 0.7%)	77	( 0.7%)	0.87	(0.63- 1.21)	-0.09%	( 0.12%)
	Neurological signs and symptoms NEC	38	( 0.4%)	33	( 0.3%)	1.14	(0.72- 1.82)	0.05%	( 0.08%)
	Sensory abnormalities NEC	7	( 0.1%)	4	( 0.0%)	1.71	(0.52- 5.58)	0.03%	( 0.03%)
	Speech and language abnormalities	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.06)	-0.00%	( 0.01%)
	Coma states	0	( 0.0%)	3	( 0.0%)	0.13	(0.01- 1.29)	-0.03%	( 0.02%)
	Nervous system disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.01%	( 0.01%)
	Neuromuscular disorders	3	( 0.0%)	5	( 0.0%)	0.60	(0.15- 2.41)	-0.02%	( 0.03%)
	Motor neurone diseases	2	( 0.0%)	5	( 0.0%)	0.42	(0.10- 1.85)	-0.03%	( 0.03%)
	Neuromuscular junction dysfunction	1	( 0.0%)	0	( 0.0%)	7.29	(0.14-367.45)	0.01%	( 0.01%)
	Peripheral neuropathies	22	( 0.2%)	21	( 0.2%)	1.04	(0.57- 1.89)	0.01%	( 0.06%)
	Acute polyneuropathies	5	( 0.0%)	0	( 0.0%)	7.29	(1.26- 42.09)	0.05%	( 0.02%)
	Mononeuropathies	12	( 0.1%)	12	( 0.1%)	0.99	(0.45- 2.21)	-0.00%	( 0.05%)
	Peripheral neuropathies NEC	5	( 0.0%)	9	( 0.1%)	0.56	(0.20- 1.60)	-0.04%	( 0.04%)
	Seizures (incl subtypes)	53	( 0.5%)	44	( 0.4%)	1.20	(0.80- 1.78)	0.09%	( 0.10%)
	Seizures and seizure disorders NEC	53	( 0.5%)	44	( 0.4%)	1.20	(0.80- 1.78)	0.09%	( 0.10%)
	Sleep disturbances (incl subtypes)	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.76)	-0.01%	( 0.01%)
	Narcolepsy and hypersomnia	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.76)	-0.01%	( 0.01%)
	Spinal cord and nerve root disorders	14	( 0.1%)	8	( 0.1%)	1.71	(0.74- 3.95)	0.06%	( 0.05%)
	Spinal cord and nerve root disorders NEC	6	( 0.1%)	7	( 0.1%)	0.85	(0.29- 2.53)	-0.01%	( 0.04%)
	Cervical spinal cord and nerve root disorders	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.60)	0.01%	( 0.01%)
	Lumbar spinal cord and nerve root disorders	7	( 0.1%)	1	( 0.0%)	4.45	(1.11- 17.80)	0.06%	( 0.03%)
	Mental impairment disorders	38	( 0.4%)	35	( 0.3%)	1.07	(0.68- 1.70)	0.03%	( 0.08%)
	Alzheimer's disease (incl subtypes)	6	( 0.1%)	3	( 0.0%)	1.92	(0.52- 7.10)	0.03%	( 0.03%)
	Dementia (excl Alzheimer's type)	30	( 0.3%)	30	( 0.3%)	0.99	(0.60- 1.64)	-0.00%	( 0.08%)
	Memory loss (excl dementia)	4	( 0.0%)	2	( 0.0%)	1.93	(0.39- 9.56)	0.02%	( 0.02%)
	Psychiatric disorders	75	( 0.7%)	75	( 0.7%)	0.99	(0.72- 1.36)	-0.00%	( 0.12%)
	Anxiety disorders and symptoms	16	( 0.2%)	16	( 0.2%)	0.99	(0.50- 1.98)	-0.00%	( 0.06%)
	Anxiety symptoms	5	( 0.0%)	6	( 0.1%)	0.82	(0.25- 2.69)	-0.01%	( 0.03%)
	Anxiety disorders NEC	11	( 0.1%)	10	( 0.1%)	1.09	(0.46- 2.56)	0.01%	( 0.04%)
	Deliria (incl confusion)	6	( 0.1%)	10	( 0.1%)	0.60	(0.23- 1.60)	-0.04%	( 0.04%)
	Confusion and disorientation	6	( 0.1%)	10	( 0.1%)	0.60	(0.23- 1.60)	-0.04%	( 0.04%)
	Depressed mood disorders and disturbances	39	( 0.4%)	32	( 0.3%)	1.21	(0.76- 1.92)	0.07%	( 0.08%)
	Depressive disorders	39	( 0.4%)	32	( 0.3%)	1.21	(0.76- 1.92)	0.07%	( 0.08%)
	Disturbances in thinking and perception	3	( 0.0%)	0	( 0.0%)	7.29	(0.76- 70.08)	0.03%	( 0.02%)
	Perception disturbances	3	( 0.0%)	0	( 0.0%)	7.29	(0.76- 70.08)	0.03%	( 0.02%)
	Manic and bipolar mood disorders and disturbances	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.16)	-0.02%	( 0.01%)
	Bipolar disorders	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.16)	-0.02%	( 0.01%)
	Personality disorders and disturbances in behaviour	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.13)	-0.02%	( 0.01%)
	Personality disorders NEC	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.13)	-0.02%	( 0.01%)
	Psychiatric disorders NEC	0	( 0.0%)	4	( 0.0%)	0.13	(0.02- 0.96)	-0.04%	( 0.02%)
	Substance-related disorders	0	( 0.0%)	4	( 0.0%)	0.13	(0.02- 0.96)	-0.04%	( 0.02%)
	Schizophrenia and other psychotic disorders	3	( 0.0%)	3	( 0.0%)	0.99	(0.20- 4.92)	-0.00%	( 0.02%)
	Psychotic disorder NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.84)	-0.01%	( 0.02%)
	Schizophrenia NEC	1	( 0.0%)	0	( 0.0%)	7.34	(0.15-369.81)	0.01%	( 0.01%)
	Sexual dysfunctions, disturbances and gender identity disorders	2	( 0.0%)	0	( 0.0%)	7.33	(0.46-117.18)	0.02%	( 0.01%)
	Sexual desire disorders	2	( 0.0%)	0	( 0.0%)	7.33	(0.46-117.18)	0.02%	( 0.01%)
	Suicidal and self-injurious behaviours NEC	15	( 0.1%)	13	( 0.1%)	1.14	(0.55- 2.40)	0.02%	( 0.05%)
	Suicidal and self-injurious behaviour	15	( 0.1%)	13	( 0.1%)	1.14	(0.55- 2.40)	0.02%	( 0.05%)
	Renal and urinary disorders	263	( 2.6%)	235	( 2.3%)	1.11	(0.93- 1.32)	0.27%	( 0.21%)
	Bladder and bladder neck disorders (excl calculi)	3	( 0.0%)	2	( 0.0%)	1.48	(0.26- 8.55)	0.01%	( 0.02%)
	Bladder disorders NEC	3	( 0.0%)	2	( 0.0%)	1.48	(0.26- 8.55)	0.01%	( 0.02%)
	Genitourinary tract disorders NEC	11	( 0.1%)	12	( 0.1%)	0.91	(0.40- 2.06)	-0.01%	( 0.05%)
	Genital and urinary tract disorders NEC	11	( 0.1%)	12	( 0.1%)	0.91	(0.40- 2.06)	-0.01%	( 0.05%)
	Nephropathies	5	( 0.0%)	3	( 0.0%)	1.63	(0.41- 6.53)	0.02%	( 0.03%)
	Glomerulonephritis and nephrotic syndrome	5	( 0.0%)	2	( 0.0%)	2.34	(0.53- 10.28)	0.03%	( 0.03%)
	Nephropathies and tubular disorders NEC	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.74)	-0.01%	( 0.01%)
	Renal disorders (excl nephropathies)	77	( 0.7%)	67	( 0.7%)	1.14	(0.82- 1.58)	0.10%	( 0.12%)
	Renal disorders NEC	13	( 0.1%)	7	( 0.1%)	1.80	(0.75- 4.33)	0.06%	( 0.04%)
	Renal failure and impairment	65	( 0.6%)	60	( 0.6%)	1.07	(0.76- 1.52)	0.05%	( 0.11%)
	Renal hypertension and related conditions	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.97)	0.01%	( 0.01%)
	Renal obstructive disorders	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.88)	-0.00%	( 0.01%)
	Renal vascular and ischaemic conditions	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.76)	0.01%	( 0.01%)
	Urethral disorders (excl calculi)	14	( 0.1%)	18	( 0.2%)	0.77	(0.39- 1.55)	-0.04%	( 0.06%)
	Structural and obstructive urethral disorders (excl congenital)	12	( 0.1%)	17	( 0.2%)	0.70	(0.34- 1.46)	-0.05%	( 0.05%)
	Urethral disorders NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.85)	-0.01%	( 0.02%)
	Urinary tract signs and symptoms	109	( 1.1%)	102	( 1.0%)	1.06	(0.81- 1.39)	0.07%	( 0.14%)
	Urinary abnormalities	37	( 0.4%)	24	( 0.2%)	1.52	(0.92- 2.51)	0.13%	( 0.08%)
	Bladder and urethral symptoms	57	( 0.6%)	66	( 0.6%)	0.86	(0.60- 1.22)	-0.09%	( 0.11%)
	Urinary tract signs and symptoms NEC	16	( 0.2%)	12	( 0.1%)	1.32	(0.63- 2.78)	0.04%	( 0.05%)
	Urolithiases	54	( 0.5%)	46	( 0.4%)	1.17	(0.79- 1.72)	0.08%	( 0.10%)
	Urinary tract lithiasis (excl renal)	54	( 0.5%)	46	( 0.4%)	1.17	(0.79- 1.72)	0.08%	( 0.10%)
	Reproductive system and breast disorders	61	( 0.6%)	50	( 0.5%)	1.21	(0.83- 1.76)	0.11%	( 0.10%)
	Breast disorders	7	( 0.1%)	4	( 0.0%)	1.71	(0.52- 5.58)	0.03%	( 0.03%)
	Benign and malignant breast neoplasms	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.85)	-0.00%	( 0.01%)
	Breast disorders NEC	6	( 0.1%)	3	( 0.0%)	1.93	(0.52- 7.14)	0.03%	( 0.03%)
	Penile and scrotal disorders (excl infections and inflammations) M	3	( 0.0%)	4	( 0.1%)	0.74	(0.17- 3.27)	-0.01%	( 0.03%)
	Penile disorders NEC (excl erection and ejaculation) M	3	( 0.0%)	4	( 0.1%)	0.74	(0.17- 3.27)	-0.01%	( 0.03%)
	Testicular and epididymal disorders M	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.85)	-0.01%	( 0.03%)
	Testicular and epididymal disorders NEC M	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.85)	-0.01%	( 0.03%)
	Male reproductive tract infections and inflammations M	2	( 0.0%)	6	( 0.1%)	0.36	(0.09- 1.46)	-0.05%	( 0.04%)
	Prostate and seminal vesicles infections and inflammations M	2	( 0.0%)	6	( 0.1%)	0.36	(0.09- 1.46)	-0.05%	( 0.04%)
	Ovarian and fallopian tube disorders F	4	( 0.2%)	0	( 0.0%)	7.33	(1.03- 52.04)	0.16%	( 0.08%)
	Ovarian and fallopian tube cysts and neoplasms F	4	( 0.2%)	0	( 0.0%)	7.33	(1.03- 52.04)	0.16%	( 0.08%)
	Prostatic disorders (excl infections and inflammations) M	25	( 0.3%)	21	( 0.3%)	1.18	(0.66- 2.11)	0.05%	( 0.09%)
	Prostatic signs, symptoms and disorders NEC M	25	( 0.3%)	21	( 0.3%)	1.18	(0.66- 2.11)	0.05%	( 0.09%)
	Reproductive tract disorders NEC	4	( 0.0%)	2	( 0.0%)	1.94	(0.39- 9.61)	0.02%	( 0.02%)
	Reproductive tract disorders NEC (excl neoplasms)	3	( 0.0%)	2	( 0.0%)	1.48	(0.26- 8.56)	0.01%	( 0.02%)
	Reproductive tract signs and symptoms NEC	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.63)	0.01%	( 0.01%)
	Uterine, pelvic and broad ligament disorders F	5	( 0.2%)	8	( 0.3%)	0.63	(0.21- 1.86)	-0.12%	( 0.14%)
	Uterine neoplasms F	2	( 0.1%)	3	( 0.1%)	0.67	(0.12- 3.84)	-0.04%	( 0.09%)
	Pelvic prolapse conditions	3	( 0.0%)	5	( 0.0%)	0.60	(0.15- 2.41)	-0.02%	( 0.03%)
	Vulvovaginal disorders (excl infections and inflammations) F	9	( 0.4%)	2	( 0.1%)	3.55	(1.09- 11.57)	0.28%	( 0.13%)
	Vulvovaginal disorders NEC F	9	( 0.4%)	2	( 0.1%)	3.55	(1.09- 11.57)	0.28%	( 0.13%)
	Respiratory, thoracic and mediastinal disorders	401	( 3.9%)	446	( 4.3%)	0.89	(0.78- 1.02)	-0.44%	( 0.28%)
	Bronchial disorders (excl neoplasms)	114	( 1.1%)	137	( 1.3%)	0.83	(0.64- 1.06)	-0.22%	( 0.15%)
	Bronchial conditions NEC	3	( 0.0%)	4	( 0.0%)	0.75	(0.17- 3.29)	-0.01%	( 0.03%)
	Bronchospasm and obstruction	112	( 1.1%)	134	( 1.3%)	0.83	(0.65- 1.06)	-0.21%	( 0.15%)
	Lower respiratory tract disorders (excl obstruction and infection)	25	( 0.2%)	36	( 0.4%)	0.69	(0.42- 1.14)	-0.11%	( 0.08%)
	Lower respiratory tract inflammatory and immunologic conditions	6	( 0.1%)	20	( 0.2%)	0.34	(0.16- 0.73)	-0.14%	( 0.05%)
	Parenchymal lung disorders NEC	19	( 0.2%)	17	( 0.2%)	1.11	(0.58- 2.13)	0.02%	( 0.06%)
	Pleural disorders	43	( 0.4%)	45	( 0.4%)	0.95	(0.62- 1.44)	-0.02%	( 0.09%)
	Pleural infections and inflammations	25	( 0.2%)	24	( 0.2%)	1.03	(0.59- 1.81)	0.01%	( 0.07%)
	Pneumothorax and pleural effusions NEC	18	( 0.2%)	22	( 0.2%)	0.81	(0.44- 1.51)	-0.04%	( 0.06%)
	Pulmonary vascular disorders	81	( 0.8%)	93	( 0.9%)	0.86	(0.64- 1.16)	-0.12%	( 0.13%)
	Pulmonary hypertensions	2	( 0.0%)	1	( 0.0%)	1.93	(0.20- 18.58)	0.01%	( 0.02%)
	Pulmonary thrombotic and embolic conditions	79	( 0.8%)	91	( 0.9%)	0.86	(0.64- 1.16)	-0.12%	( 0.13%)
	Vascular pulmonary disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.01%	( 0.01%)
	Respiratory disorders NEC	113	( 1.1%)	119	( 1.2%)	0.94	(0.73- 1.22)	-0.06%	( 0.15%)
	Breathing abnormalities	80	( 0.8%)	98	( 1.0%)	0.81	(0.60- 1.08)	-0.18%	( 0.13%)
	Coughing and associated symptoms	13	( 0.1%)	11	( 0.1%)	1.17	(0.53- 2.61)	0.02%	( 0.05%)
	Lower respiratory tract signs and symptoms	2	( 0.0%)	0	( 0.0%)	7.32	(0.46-117.09)	0.02%	( 0.01%)
	Respiratory signs and symptoms NEC	6	( 0.1%)	1	( 0.0%)	4.14	(0.94- 18.20)	0.05%	( 0.03%)
	Upper respiratory tract signs and symptoms	1	( 0.0%)	4	( 0.0%)	0.30	(0.05- 1.73)	-0.03%	( 0.02%)
	Respiratory failures (excl neonatal)	7	( 0.1%)	4	( 0.0%)	1.72	(0.53- 5.59)	0.03%	( 0.03%)
	Respiratory tract disorders NEC	4	( 0.0%)	1	( 0.0%)	3.32	(0.57- 19.15)	0.03%	( 0.02%)
	Upper respiratory tract disorders (excl infections)	59	( 0.6%)	52	( 0.5%)	1.13	(0.78- 1.63)	0.07%	( 0.10%)
	Nasal disorders NEC	59	( 0.6%)	50	( 0.5%)	1.17	(0.80- 1.70)	0.09%	( 0.10%)
	Pharyngeal disorders (excl infections and neoplasms)	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.16)	-0.02%	( 0.01%)
	Skin and subcutaneous tissue disorders	119	( 1.2%)	111	( 1.1%)	1.06	(0.82- 1.38)	0.08%	( 0.15%)
	Angioedema and urticaria	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.34)	0.01%	( 0.01%)
	Urticarias	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.34)	0.01%	( 0.01%)
	Cornification and dystrophic skin disorders	18	( 0.2%)	5	( 0.0%)	3.07	(1.35- 6.94)	0.13%	( 0.05%)
	Skin preneoplastic conditions NEC	18	( 0.2%)	5	( 0.0%)	3.07	(1.35- 6.94)	0.13%	( 0.05%)
	Epidermal and dermal conditions	39	( 0.4%)	34	( 0.3%)	1.14	(0.72- 1.80)	0.05%	( 0.08%)
	Bullous conditions	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.75)	-0.01%	( 0.01%)
	Connective tissue disorders	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.78)	-0.01%	( 0.01%)
	Dermal and epidermal conditions NEC	18	( 0.2%)	15	( 0.1%)	1.19	(0.60- 2.34)	0.03%	( 0.06%)
	Dermatitis and eczema	9	( 0.1%)	4	( 0.0%)	2.14	(0.72- 6.35)	0.05%	( 0.04%)
	Erythemas	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.32)	0.01%	( 0.01%)
	Papulosquamous conditions	1	( 0.0%)	0	( 0.0%)	7.33	(0.15-369.55)	0.01%	( 0.01%)
	Skin injuries and mechanical dermatoses	3	( 0.0%)	3	( 0.0%)	0.99	(0.20- 4.93)	-0.00%	( 0.02%)
	Pruritus NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.01%	( 0.01%)
	Rashes, eruptions and exanthems NEC	6	( 0.1%)	5	( 0.0%)	1.19	(0.37- 3.88)	0.01%	( 0.03%)
	Psoriatic conditions	2	( 0.0%)	4	( 0.0%)	0.51	(0.10- 2.53)	-0.02%	( 0.02%)
	Skin and subcutaneous tissue disorders NEC	59	( 0.6%)	68	( 0.7%)	0.86	(0.61- 1.22)	-0.09%	( 0.11%)
	Panniculitides	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.01%	( 0.01%)
	Skin and subcutaneous tissue ulcerations	51	( 0.5%)	59	( 0.6%)	0.86	(0.59- 1.25)	-0.08%	( 0.10%)
	Skin and subcutaneous malformations and anomalies NEC	5	( 0.0%)	3	( 0.0%)	1.64	(0.41- 6.54)	0.02%	( 0.03%)
	Skin and subcutaneous conditions NEC	3	( 0.0%)	5	( 0.0%)	0.60	(0.15- 2.41)	-0.02%	( 0.03%)
	Skin appendage conditions	2	( 0.0%)	5	( 0.0%)	0.42	(0.10- 1.85)	-0.03%	( 0.03%)
	Alopecias	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.72)	-0.01%	( 0.01%)
	Apocrine and eccrine gland disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.01%	( 0.01%)
	Nail and nail bed conditions (excl infections and infestations)	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.59)	-0.02%	( 0.02%)
	Rosaceas	1	( 0.0%)	0	( 0.0%)	7.27	(0.14-366.71)	0.01%	( 0.01%)
	Skin vascular abnormalities	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.94)	0.01%	( 0.01%)
	Purpura and related conditions	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.94)	0.01%	( 0.01%)
	Social circumstances	3	( 0.0%)	1	( 0.0%)	2.71	(0.38- 19.26)	0.02%	( 0.02%)
	Legal issues	2	( 0.0%)	0	( 0.0%)	7.37	(0.46-117.86)	0.02%	( 0.01%)
	Criminal activity	2	( 0.0%)	0	( 0.0%)	7.37	(0.46-117.86)	0.02%	( 0.01%)
	Lifestyle issues	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.97)	-0.00%	( 0.01%)
	Alcohol product use	1	( 0.0%)	0	( 0.0%)	7.37	(0.15-371.61)	0.01%	( 0.01%)
	Social issues NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.01%	( 0.01%)
	Surgical and medical procedures	3468	(33.8%)	3676	(35.8%)	0.92	(0.88- 0.96)	-2.03%	( 0.66%)
	Vascular therapeutic procedures	941	( 9.2%)	1208	(11.8%)	0.76	(0.70- 0.83)	-2.60%	( 0.43%)
	Aortic therapeutic procedures	66	( 0.6%)	62	( 0.6%)	1.06	(0.75- 1.49)	0.04%	( 0.11%)
	Arterial therapeutic procedures (excl aortic)	605	( 5.9%)	837	( 8.2%)	0.71	(0.64- 0.79)	-2.26%	( 0.36%)
	Vascular therapeutic procedures NEC	274	( 2.7%)	336	( 3.3%)	0.81	(0.69- 0.95)	-0.60%	( 0.24%)
	Venous therapeutic procedures	42	( 0.4%)	56	( 0.5%)	0.75	(0.50- 1.11)	-0.14%	( 0.10%)
	Bone and joint therapeutic procedures	624	( 6.1%)	613	( 6.0%)	1.01	(0.90- 1.13)	0.11%	( 0.33%)
	Bone therapeutic procedures NEC	15	( 0.1%)	15	( 0.1%)	0.99	(0.48- 2.02)	-0.00%	( 0.05%)
	Joint therapeutic procedures	434	( 4.2%)	411	( 4.0%)	1.05	(0.92- 1.20)	0.22%	( 0.28%)
	Limb therapeutic procedures	191	( 1.9%)	210	( 2.0%)	0.90	(0.74- 1.10)	-0.19%	( 0.19%)
	Fracture treatments (excl skull and spine)	3	( 0.0%)	3	( 0.0%)	0.99	(0.20- 4.93)	-0.00%	( 0.02%)
	Breast therapeutic procedures	31	( 0.3%)	40	( 0.4%)	0.77	(0.48- 1.23)	-0.09%	( 0.08%)
	Mastectomies	8	( 0.1%)	21	( 0.2%)	0.40	(0.20- 0.84)	-0.13%	( 0.05%)
	Breast therapeutic procedures NEC	24	( 0.2%)	22	( 0.2%)	1.08	(0.61- 1.93)	0.02%	( 0.07%)
	Cardiac therapeutic procedures	233	( 2.3%)	236	( 2.3%)	0.98	(0.82- 1.17)	-0.03%	( 0.21%)
	Cardiac device therapeutic procedures	124	( 1.2%)	123	( 1.2%)	1.00	(0.78- 1.28)	0.01%	( 0.15%)
	Cardiac valve therapeutic procedures	43	( 0.4%)	30	( 0.3%)	1.41	(0.89- 2.24)	0.13%	( 0.08%)
	Congenital cardiovascular anomaly therapeutic procedures	2	( 0.0%)	3	( 0.0%)	0.66	(0.12- 3.84)	-0.01%	( 0.02%)
	Cardiac therapeutic procedures NEC	70	( 0.7%)	90	( 0.9%)	0.77	(0.57- 1.05)	-0.19%	( 0.12%)
	Nervous system, skull and spine therapeutic procedures	156	( 1.5%)	148	( 1.4%)	1.05	(0.84- 1.31)	0.08%	( 0.17%)
	Autonomic nerve therapeutic procedures	11	( 0.1%)	14	( 0.1%)	0.78	(0.36- 1.71)	-0.03%	( 0.05%)
	Peripheral nerve therapeutic procedures	84	( 0.8%)	73	( 0.7%)	1.14	(0.84- 1.56)	0.11%	( 0.12%)
	Skull and brain therapeutic procedures	6	( 0.1%)	4	( 0.0%)	1.48	(0.43- 5.12)	0.02%	( 0.03%)
	Spine and spinal cord therapeutic procedures	50	( 0.5%)	56	( 0.5%)	0.89	(0.61- 1.30)	-0.06%	( 0.10%)
	Nervous system therapeutic procedures NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.95)	-0.00%	( 0.01%)
	Cerebrospinal fluid therapeutic procedures	5	( 0.0%)	2	( 0.0%)	2.29	(0.52- 10.10)	0.03%	( 0.03%)
	Endocrine gland therapeutic procedures	16	( 0.2%)	12	( 0.1%)	1.32	(0.63- 2.77)	0.04%	( 0.05%)
	Hormonal therapeutic procedures NEC	7	( 0.1%)	8	( 0.1%)	0.87	(0.32- 2.39)	-0.01%	( 0.04%)
	Parathyroid gland therapeutic procedures	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-372.19)	0.01%	( 0.01%)
	Pituitary and hypothalamic therapeutic procedures	2	( 0.0%)	0	( 0.0%)	7.30	(0.46-116.70)	0.02%	( 0.01%)
	Thyroid therapeutic procedures	6	( 0.1%)	4	( 0.0%)	1.48	(0.43- 5.12)	0.02%	( 0.03%)
	Eye therapeutic procedures	500	( 4.9%)	516	( 5.0%)	0.96	(0.85- 1.08)	-0.16%	( 0.30%)
	Corneal and scleral therapeutic procedures	5	( 0.0%)	7	( 0.1%)	0.71	(0.23- 2.20)	-0.02%	( 0.03%)
	Eyelid therapeutic procedures	23	( 0.2%)	16	( 0.2%)	1.42	(0.76- 2.66)	0.07%	( 0.06%)
	Iris and ciliary body therapeutic procedures	6	( 0.1%)	2	( 0.0%)	2.71	(0.68- 10.84)	0.04%	( 0.03%)
	Lacrimal apparatus therapeutic procedures	6	( 0.1%)	7	( 0.1%)	0.85	(0.29- 2.53)	-0.01%	( 0.04%)
	Lens therapeutic procedures	368	( 3.6%)	396	( 3.9%)	0.92	(0.80- 1.06)	-0.27%	( 0.26%)
	Eye therapeutic procedures NEC	115	( 1.1%)	111	( 1.1%)	1.03	(0.79- 1.33)	0.04%	( 0.15%)
	Orbit and globe therapeutic procedures	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.02%	( 0.01%)
	Retinal therapeutic procedures	9	( 0.1%)	11	( 0.1%)	0.81	(0.34- 1.95)	-0.02%	( 0.04%)
	Gastrointestinal therapeutic procedures	579	( 5.6%)	557	( 5.4%)	1.03	(0.92- 1.16)	0.21%	( 0.32%)
	Anorectal therapeutic procedures	78	( 0.8%)	73	( 0.7%)	1.06	(0.77- 1.46)	0.05%	( 0.12%)
	Gastric therapeutic procedures	17	( 0.2%)	14	( 0.1%)	1.20	(0.59- 2.43)	0.03%	( 0.05%)
	Gastrointestinal therapeutic procedures NEC	42	( 0.4%)	59	( 0.6%)	0.71	(0.48- 1.04)	-0.17%	( 0.10%)
	Hernia repairs	349	( 3.4%)	299	( 2.9%)	1.16	(0.99- 1.35)	0.49%	( 0.24%)
	Large intestine therapeutic procedures	89	( 0.9%)	112	( 1.1%)	0.79	(0.60- 1.04)	-0.22%	( 0.14%)
	Abdominal therapeutic procedures NEC	13	( 0.1%)	14	( 0.1%)	0.92	(0.43- 1.96)	-0.01%	( 0.05%)
	Oesophageal therapeutic procedures	21	( 0.2%)	19	( 0.2%)	1.10	(0.59- 2.04)	0.02%	( 0.06%)
	Pancreatic therapeutic procedures	4	( 0.0%)	2	( 0.0%)	1.92	(0.39- 9.53)	0.02%	( 0.02%)
	Small intestine therapeutic procedures	9	( 0.1%)	10	( 0.1%)	0.89	(0.36- 2.20)	-0.01%	( 0.04%)
	Head and neck therapeutic procedures	154	( 1.5%)	148	( 1.4%)	1.03	(0.82- 1.30)	0.06%	( 0.17%)
	Dental and gingival therapeutic procedures	24	( 0.2%)	27	( 0.3%)	0.88	(0.51- 1.53)	-0.03%	( 0.07%)
	External ear therapeutic procedures	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.77)	-0.01%	( 0.01%)
	Facial therapeutic procedures	8	( 0.1%)	7	( 0.1%)	1.14	(0.41- 3.13)	0.01%	( 0.04%)
	Laryngeal therapeutic procedures	11	( 0.1%)	7	( 0.1%)	1.55	(0.61- 3.90)	0.04%	( 0.04%)
	Middle ear therapeutic procedures	9	( 0.1%)	13	( 0.1%)	0.69	(0.30- 1.59)	-0.04%	( 0.05%)
	Nasal therapeutic procedures	60	( 0.6%)	48	( 0.5%)	1.24	(0.85- 1.81)	0.12%	( 0.10%)
	Paranasal therapeutic procedures	14	( 0.1%)	9	( 0.1%)	1.54	(0.68- 3.48)	0.05%	( 0.05%)
	Pharyngeal therapeutic procedures	10	( 0.1%)	6	( 0.1%)	1.64	(0.61- 4.36)	0.04%	( 0.04%)
	Salivary gland therapeutic procedures	2	( 0.0%)	7	( 0.1%)	0.33	(0.09- 1.21)	-0.05%	( 0.03%)
	Tongue therapeutic procedures	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.82)	-0.00%	( 0.01%)
	Tonsillar therapeutic procedures	1	( 0.0%)	3	( 0.0%)	0.36	(0.05- 2.59)	-0.02%	( 0.02%)
	Head, neck and oral cavity therapeutic procedures NEC	20	( 0.2%)	21	( 0.2%)	0.95	(0.51- 1.75)	-0.01%	( 0.06%)
	Hepatobiliary therapeutic procedures	124	( 1.2%)	124	( 1.2%)	0.99	(0.77- 1.27)	-0.00%	( 0.15%)
	Biliary tract and gallbladder therapeutic procedures	121	( 1.2%)	124	( 1.2%)	0.97	(0.75- 1.24)	-0.03%	( 0.15%)
	Hepatic therapeutic procedures	3	( 0.0%)	0	( 0.0%)	7.36	(0.77- 70.77)	0.03%	( 0.02%)
	Hepatobiliary radiotherapies	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.86)	0.01%	( 0.01%)
	Haematological and lymphoid tissue therapeutic procedures	57	( 0.6%)	67	( 0.7%)	0.84	(0.59- 1.20)	-0.10%	( 0.11%)
	Blood and blood product treatment	30	( 0.3%)	46	( 0.4%)	0.65	(0.41- 1.02)	-0.16%	( 0.08%)
	Lymphoid tissue therapeutic procedures	6	( 0.1%)	4	( 0.0%)	1.47	(0.43- 5.09)	0.02%	( 0.03%)
	Haematological therapeutic procedures NEC	21	( 0.2%)	18	( 0.2%)	1.15	(0.62- 2.16)	0.03%	( 0.06%)
	Male genital tract therapeutic procedures M	334	( 4.3%)	302	( 3.9%)	1.10	(0.94- 1.28)	0.41%	( 0.32%)
	Epididymal therapeutic procedures M	9	( 0.1%)	11	( 0.1%)	0.81	(0.34- 1.95)	-0.03%	( 0.06%)
	Penile therapeutic procedures M	24	( 0.3%)	22	( 0.3%)	1.08	(0.61- 1.93)	0.03%	( 0.09%)
	Prostatic therapeutic procedures M	276	( 3.6%)	254	( 3.3%)	1.08	(0.91- 1.28)	0.28%	( 0.29%)
	Male genital tract therapeutic procedures NEC M	3	( 0.0%)	1	( 0.0%)	2.70	(0.38- 19.14)	0.03%	( 0.03%)
	Testicular and scrotal therapeutic procedures M	29	( 0.4%)	17	( 0.2%)	1.67	(0.94- 2.98)	0.16%	( 0.09%)
	Obstetric and gynaecological therapeutic procedures F	109	( 4.3%)	113	( 4.4%)	0.96	(0.74- 1.24)	-0.16%	( 0.57%)
	Cervix therapeutic procedures F	26	( 1.0%)	27	( 1.1%)	0.96	(0.56- 1.64)	-0.04%	( 0.29%)
	Contraceptive methods female F	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-373.15)	0.04%	( 0.04%)
	External female genital therapeutic procedures F	1	( 0.0%)	2	( 0.1%)	0.51	(0.05- 4.90)	-0.04%	( 0.07%)
	Ovarian therapeutic procedures F	5	( 0.2%)	6	( 0.2%)	0.83	(0.25- 2.71)	-0.04%	( 0.13%)
	Uterine therapeutic procedures F	53	( 2.1%)	46	( 1.8%)	1.15	(0.77- 1.70)	0.27%	( 0.39%)
	Vaginal therapeutic procedures F	29	( 1.1%)	37	( 1.5%)	0.78	(0.48- 1.26)	-0.32%	( 0.32%)
	Renal and urinary tract therapeutic procedures	147	( 1.4%)	132	( 1.3%)	1.10	(0.87- 1.40)	0.15%	( 0.16%)
	Bladder therapeutic procedures	74	( 0.7%)	70	( 0.7%)	1.05	(0.76- 1.45)	0.04%	( 0.12%)
	Renal therapeutic procedures	53	( 0.5%)	41	( 0.4%)	1.28	(0.85- 1.92)	0.12%	( 0.09%)
	Therapeutic bladder catheterisation	24	( 0.2%)	27	( 0.3%)	0.88	(0.51- 1.52)	-0.03%	( 0.07%)
	Ureteric therapeutic procedures	1	( 0.0%)	1	( 0.0%)	0.99	(0.06- 15.90)	-0.00%	( 0.01%)
	Urethral therapeutic procedures	3	( 0.0%)	0	( 0.0%)	7.33	(0.76- 70.46)	0.03%	( 0.02%)
	Respiratory tract therapeutic procedures	27	( 0.3%)	22	( 0.2%)	1.22	(0.69- 2.13)	0.05%	( 0.07%)
	Bronchial and pulmonary therapeutic procedures	9	( 0.1%)	10	( 0.1%)	0.89	(0.36- 2.19)	-0.01%	( 0.04%)
	Chest wall and mediastinal therapeutic procedures	11	( 0.1%)	7	( 0.1%)	1.55	(0.61- 3.90)	0.04%	( 0.04%)
	Pleural therapeutic procedures	3	( 0.0%)	5	( 0.0%)	0.60	(0.15- 2.39)	-0.02%	( 0.03%)
	Tracheal therapeutic procedures	5	( 0.0%)	1	( 0.0%)	3.76	(0.76- 18.64)	0.04%	( 0.02%)
	Skin and subcutaneous tissue therapeutic procedures	149	( 1.5%)	141	( 1.4%)	1.05	(0.83- 1.32)	0.08%	( 0.16%)
	Nail therapeutic procedures	16	( 0.2%)	13	( 0.1%)	1.22	(0.59- 2.53)	0.03%	( 0.05%)
	Skin and subcutaneous tissue therapeutic procedures NEC	19	( 0.2%)	25	( 0.2%)	0.76	(0.42- 1.37)	-0.06%	( 0.06%)
	Skin grafts	13	( 0.1%)	17	( 0.2%)	0.76	(0.37- 1.55)	-0.04%	( 0.05%)
	Skin lesion excisions	103	( 1.0%)	89	( 0.9%)	1.15	(0.87- 1.53)	0.14%	( 0.13%)
	Soft tissue therapeutic procedures	51	( 0.5%)	56	( 0.5%)	0.90	(0.62- 1.32)	-0.05%	( 0.10%)
	Fascial and bursal therapeutic procedures	23	( 0.2%)	25	( 0.2%)	0.91	(0.52- 1.61)	-0.02%	( 0.07%)
	Muscle therapeutic procedures	2	( 0.0%)	1	( 0.0%)	1.93	(0.20- 18.53)	0.01%	( 0.02%)
	Tendon therapeutic procedures	14	( 0.1%)	19	( 0.2%)	0.73	(0.37- 1.45)	-0.05%	( 0.06%)
	Soft tissue therapeutic procedures NEC	12	( 0.1%)	11	( 0.1%)	1.08	(0.48- 2.44)	0.01%	( 0.05%)
	Therapeutic procedures and supportive care NEC	228	( 2.2%)	282	( 2.7%)	0.80	(0.67- 0.95)	-0.53%	( 0.22%)
	Anaesthesia and allied procedures	42	( 0.4%)	31	( 0.3%)	1.34	(0.85- 2.12)	0.11%	( 0.08%)
	Analgesia supportive care	6	( 0.1%)	6	( 0.1%)	0.99	(0.32- 3.06)	-0.00%	( 0.03%)
	Chemotherapies	47	( 0.5%)	51	( 0.5%)	0.91	(0.61- 1.36)	-0.04%	( 0.10%)
	Therapeutic procedures NEC	100	( 1.0%)	161	( 1.6%)	0.62	(0.49- 0.79)	-0.59%	( 0.16%)
	Phototherapies	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.97)	-0.00%	( 0.01%)
	Radiotherapies site unspecified	40	( 0.4%)	45	( 0.4%)	0.88	(0.58- 1.35)	-0.05%	( 0.09%)
	Drug withdrawal therapies	1	( 0.0%)	5	( 0.0%)	0.26	(0.05- 1.30)	-0.04%	( 0.02%)
	Dietary and nutritional therapies	1	( 0.0%)	0	( 0.0%)	7.32	(0.15-368.98)	0.01%	( 0.01%)
	Vascular disorders	325	( 3.2%)	357	( 3.5%)	0.90	(0.77- 1.05)	-0.31%	( 0.25%)
	Aneurysms and artery dissections	60	( 0.6%)	62	( 0.6%)	0.96	(0.67- 1.37)	-0.02%	( 0.11%)
	Aneurysms and dissections non-site specific	7	( 0.1%)	7	( 0.1%)	0.99	(0.35- 2.82)	-0.00%	( 0.04%)
	Aortic aneurysms and dissections	49	( 0.5%)	52	( 0.5%)	0.93	(0.63- 1.38)	-0.03%	( 0.10%)
	Peripheral aneurysms and dissections	5	( 0.0%)	3	( 0.0%)	1.64	(0.41- 6.55)	0.02%	( 0.03%)
	Arteriosclerosis, stenosis, vascular insufficiency and necrosis	45	( 0.4%)	50	( 0.5%)	0.89	(0.60- 1.34)	-0.05%	( 0.09%)
	Aortic necrosis and vascular insufficiency	7	( 0.1%)	7	( 0.1%)	0.99	(0.35- 2.83)	-0.00%	( 0.04%)
	Non-site specific necrosis and vascular insufficiency NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.91)	-0.01%	( 0.02%)
	Peripheral vasoconstriction, necrosis and vascular insufficiency	37	( 0.4%)	41	( 0.4%)	0.90	(0.57- 1.40)	-0.04%	( 0.09%)
	Decreased and nonspecific blood pressure disorders and shock	39	( 0.4%)	33	( 0.3%)	1.17	(0.74- 1.86)	0.06%	( 0.08%)
	Circulatory collapse and shock	2	( 0.0%)	0	( 0.0%)	7.32	(0.46-117.04)	0.02%	( 0.01%)
	Vascular hypotensive disorders	37	( 0.4%)	33	( 0.3%)	1.11	(0.69- 1.77)	0.04%	( 0.08%)
	Embolism and thrombosis	116	( 1.1%)	122	( 1.2%)	0.94	(0.73- 1.21)	-0.06%	( 0.15%)
	Aortic embolism and thrombosis	1	( 0.0%)	0	( 0.0%)	7.27	(0.14-366.27)	0.01%	( 0.01%)
	Non-site specific embolism and thrombosis	4	( 0.0%)	6	( 0.1%)	0.66	(0.19- 2.29)	-0.02%	( 0.03%)
	Peripheral embolism and thrombosis	112	( 1.1%)	116	( 1.1%)	0.96	(0.74- 1.24)	-0.04%	( 0.15%)
	Lymphatic vessel disorders	0	( 0.0%)	3	( 0.0%)	0.13	(0.01- 1.29)	-0.03%	( 0.02%)
	Lymphoedemas	0	( 0.0%)	3	( 0.0%)	0.13	(0.01- 1.29)	-0.03%	( 0.02%)
	Vascular disorders NEC	7	( 0.1%)	18	( 0.2%)	0.41	(0.19- 0.90)	-0.11%	( 0.05%)
	Peripheral vascular disorders NEC	7	( 0.1%)	17	( 0.2%)	0.43	(0.19- 0.96)	-0.10%	( 0.05%)
	Vascular malformations and acquired anomalies	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.01%	( 0.01%)
	Vascular haemorrhagic disorders	8	( 0.1%)	9	( 0.1%)	0.88	(0.34- 2.28)	-0.01%	( 0.04%)
	Haemorrhages NEC	8	( 0.1%)	9	( 0.1%)	0.88	(0.34- 2.28)	-0.01%	( 0.04%)
	Vascular injuries	2	( 0.0%)	2	( 0.0%)	0.99	(0.14- 7.03)	-0.00%	( 0.02%)
	Arterial and aortic injuries	2	( 0.0%)	2	( 0.0%)	0.99	(0.14- 7.03)	-0.00%	( 0.02%)
	Vascular inflammations	12	( 0.1%)	20	( 0.2%)	0.60	(0.30- 1.20)	-0.08%	( 0.06%)
	Arterial inflammations	3	( 0.0%)	10	( 0.1%)	0.34	(0.11- 1.00)	-0.07%	( 0.04%)
	Vasculitides NEC	3	( 0.0%)	1	( 0.0%)	2.71	(0.38- 19.24)	0.02%	( 0.02%)
	Phlebitis NEC	6	( 0.1%)	9	( 0.1%)	0.66	(0.24- 1.83)	-0.03%	( 0.04%)
	Venous varices	4	( 0.0%)	7	( 0.1%)	0.58	(0.18- 1.88)	-0.03%	( 0.03%)
	Varicose veins non-site specific	4	( 0.0%)	7	( 0.1%)	0.58	(0.18- 1.88)	-0.03%	( 0.03%)
	Vascular hypertensive disorders	38	( 0.4%)	40	( 0.4%)	0.94	(0.60- 1.47)	-0.02%	( 0.09%)
	Accelerated and malignant hypertension	4	( 0.0%)	1	( 0.0%)	3.30	(0.57- 19.07)	0.03%	( 0.02%)
	Vascular hypertensive disorders NEC	35	( 0.3%)	39	( 0.4%)	0.89	(0.56- 1.40)	-0.04%	( 0.08%)