Table 3.

Adverse event of special interest

Variable	Safety set (n=2,228)
Any adverse event	381 (17.10) [623]
Aspartate aminotransferase increaseda	5 (0.22) [5]
Alanine aminotransferase increaseda	6 (0.27) [6]
Bronchitis	2 (0.09) [2]
Cancer
Bladder cancer	0 (0.00) [0]
Gastric cancer	1 (0.04) [1]
Lung neoplasm malignant	1 (0.04) [1]
Non-small cell lung cancer	1 (0.04) [1]
Cerebrovascular diseaseb	18 (0.81) [18]
Congestive heart failure	1 (0.04) [1]
Cardiovascular diseasec	18 (0.81) [19]
Constipation	9 (0.40) [9]
Diarrhea	4 (0.18) [4]
Edemad	44 (1.97) [48]
Sexa
Male	15 (0.67) [16]
Female	29 (1.30) [32]
Hypoglycemiae	55 (2.47) [63]
Sex
Male	30 (1.35)
Female	25 (1.12)
Age, yr	64.78±9.94
Insulin or sulfonylurea administration at occurrence time
No	7 (0.32)
Yes	48 (2.15)
Fracturef	26 (1.17) [27]
Sex
Male	10 (0.45)
Female	16 (0.72)
Age, yr	72.11±11.92
Age group, yrg
<20	0 (0.00)
≥20 to <30	0 (0.00)
≥30 to <40	0 (0.00)
≥40 to <50	1 (0.54)
≥50 to <60	3 (0.57)
≥60 to <70	6 (0.81)
≥70 to <80	7 (1.32)
≥80 to <90	8 (4.17)
≥90	1 (8.33)
Jaundicea	0 (0.00) [0]
Proteinuria	2 (0.09) [2]
Pneumonia	0 (0.00) [0]
Rash	0 (0.00) [0]
Upper respiratory tract infection	5 (0.22) [5]
Urinary tract infection	4 (0.18) [4]
Vomiting	0 (0.00) [0]

Values are presented as number of patients (%) [number of events] or mean±standard deviation.

^aBy system organ class (MedDRA version 21.1 preferred term),

^bDefinition of cerebrovascular disease: carotid arteriosclerosis, carotid artery stenosis, cerebral arteriosclerosis, cerebral artery stenosis, cerebral infarction, intracranial aneurysm, migraine, neurodegenerative disorder, syncope, vascular dementia,

^cDefinition of cardiovascular disease: acute myocardial infarction, angina pectoris, angina unstable, atrial fibrillation, coronary artery disease, coronary artery occlusion, microvascular coronary artery disease, myocardial infarction, tachycardia,

^dDefinition of edema: face oedema, generalised oedema, oedema, oedema peripheral, lymphoedema, periorbital oedema,

^eDefinition of hypoglycemia: hypoglycaemia, blood glucose decreased,

^FDefinition of fracture: ankle fracture, clavicle fracture, facial bones fracture, femoral neck fracture, femur fracture, foot fracture, fracture, lumbar vertebral fracture, open fracture, pelvic fracture, radius fracture, rib fracture, spinal compression fracture, upper limb fracture, wrist fracture, osteoporotic fracture, pathological fracture,

^gNumber of patients per age group cluster.