Table 3.
Treatment-emergent adverse events over 2 years by system organ class and preferred term reported by ≥5% in any one group (safety population)
Liraglutide 1.2 mg (N = 251) | Liraglutide 1.8 mg (N = 246) | Glimepiride 8 mg (N = 248) | |
---|---|---|---|
All adverse events | 213(85%) | 207(84%) | 194(78%) |
Gastrointestinal disorders | 135(54%) | 130(53%) | 70(28%) |
Constipation | 21(8%) | 29(12%) | 12(5%) |
Diarrhoea | 44(18%) | 48(20%) | 23(9%) |
Flatulence | 4(2%) | 13(5%) | 5(2%) |
Nausea | 72(29%) | 75(31%) | 21(9%) |
Vomiting | 33(13%) | 25(10%) | 10(4%) |
Cardiac disorders | 8(3%) | 11(5%) | 14(6%) |
Eye disorders | 15(6%) | 14(6%) | 16(7%) |
General disorders and administration site conditions | 42(17%) | 51(21%) | 39(16%) |
Fatigue | 8(3%) | 13(5%) | 9(4%) |
Infections and infestations | 134(53%) | 124(50%) | 114(46%) |
Bronchitis | 15(6%) | 9(4%) | 11(4%) |
Influenza | 23(9%) | 27(11%) | 21(9%) |
Nasopharyngitis | 23(9%) | 16(7%) | 18(7%) |
Sinusitis | 21(8%) | 18(7%) | 18(7%) |
Upper respiratory tract infection | 36(14%) | 33(13%) | 22(9%) |
Urinary tract infection | 26(10%) | 15(6%) | 13(5%) |
Injury, poisoning and procedural complications | 32(13%) | 35(14%) | 37(15%) |
Investigations | 23(9%) | 31(13%) | 25(10%) |
Metabolism and nutrition disorders | 45(18%) | 42(17%) | 36(15%) |
Musculoskeletal, connective tissue disorders | 61(24%) | 61(25%) | 58(23%) |
Arthralgia | 11(4%) | 6(2%) | 15(6%) |
Back pain | 18(7%) | 18(7%) | 17(7%) |
Pain in extremity | 9(4%) | 15(6%) | 8(3%) |
Nervous system disorders | 65(26%) | 58(24%) | 58(23%) |
Dizziness | 13(5%) | 19(8%) | 13(5%) |
Headache | 28(11%) | 18(7%) | 23(9%) |
Psychiatric disorders | 24(10%) | 28(11%) | 16(7%) |
Depression | 8(3%) | 14(6%) | 5(2%) |
Renal and urinary disorders | 13(5%) | 11(5%) | 15(6%) |
Reproductive system and breast disorders | 12(5%) | 14(6%) | 12(5%) |
Respiratory, thoracic and mediastinal disorders | 23(9%) | 42(17%) | 36(15%) |
Cough | 5(2%) | 14(6%) | 11(4%) |
Skin and subcutaneous tissue disorders | 26(10%) | 31(13%) | 20(8%) |
Vascular disorders | 20(8%) | 20(8%) | 20(8%) |
Hypertension | 14(6%) | 11(5%) | 17(7%) |
Data are n (%).