Table 3

TEAEs by system organ class and preferred term, with frequency ≥5% in one or more treatment arms (safety analysis set)

Placebo (n = 46)SemaglutideLiraglutide
0.1 mg (n = 47)0.2 mg (n = 43)0.4 mg (n = 48)0.8 mg (n = 42)0.8 mg E (n = 43)1.6 mg E (n = 47)1.2 mg (n = 45)1.8 mg (n = 50)
TEAEs, n (%)20 (43.5)28 (59.6)24 (55.8)35 (72.9)36 (85.7)31 (72.1)44 (93.6)25 (55.6)31 (62.0)
GI disorders5 (10.9)16 (34.0)9 (20.9)22 (45.8)33 (78.6)27 (62.8)35 (74.5)15 (33.3)15 (30.0)
 Nausea2 (4.3)4 (8.5)5 (11.6)13 (27.1)25 (59.5)17 (39.5)27 (57.4)11 (24.4)4 (8.0)
 Vomiting1 (2.2)0 (0.0)3 (7.0)7 (14.6)17 (40.5)13 (30.2)13 (27.7)4 (8.9)6 (12.0)
 Diarrhea0 (0.0)5 (10.6)2 (4.7)7 (14.6)8 (19.0)7 (16.3)11 (23.4)2 (4.4)7 (14.0)
 Dyspepsia1 (2.2)5 (10.6)0 (0.0)4 (8.3)4 (9.5)4 (9.3)6 (12.8)5 (11.1)4 (8.0)
 Constipation0 (0.0)0 (0.0)2 (4.7)2 (4.2)1 (2.4)3 (7.0)3 (6.4)3 (6.7)1 (2.0)
Nervous system disorders7 (15.2)11 (23.4)4 (9.3)11 (22.9)8 (19.0)3 (7.0)5 (10.6)10 (22.2)6 (12.0)
 Headache3 (6.5)7 (14.9)3 (7.0)4 (8.3)5 (11.9)1 (2.3)3 (6.4)4 (8.9)2 (4.0)
 Dizziness1 (2.2)3 (6.4)0 (0.0)2 (4.2)1 (2.4)0 (0.0)0 (0.0)2 (4.4)0 (0.0)
 Lethargy0 (0.0)0 (0.0)0 (0.0)1 (2.1)0 (0.0)1 (2.3)0 (0.0)3 (6.7)0 (0.0)
Infections/infestations6 (13.0)9 (19.1)7 (16.3)10 (20.8)4 (9.5)6 (14.0)10 (21.3)2 (4.4)9 (18.0)
 Nasopharyngitis4 (8.7)6 (12.8)0 (0.0)4 (8.3)2 (4.8)2 (4.7)3 (6.4)1 (2.2)2 (4.0)
 Gastroenteritis0 (0.0)0 (0.0)0 (0.0)1 (2.1)0 (0.0)0 (0.0)2 (4.3)0 (0.0)3 (6.0)
 Urinary tract infection0 (0.0)0 (0.0)3 (7.0)0 (0.0)1 (2.4)1 (2.3)2 (4.3)0 (0.0)0 (0.0)
General disorders and administration site conditions1 (2.2)1 (2.1)2 (4.7)7 (14.6)4 (9.5)4 (9.3)11 (23.4)3 (6.7)5 (10.0)
 Fatigue1 (2.2)1 (2.1)0 (0.0)3 (6.3)0 (0.0)0 (0.0)6 (12.8)0 (0.0)2 (4.0)
 Asthenia0 (0.0)0 (0.0)0 (0.0)2 (4.2)3 (7.1)3 (7.0)5 (10.6)0 (0.0)0 (0.0)
Metabolism/nutrition disorders1 (2.2)2 (4.3)3 (7.0)4 (8.3)10 (23.8)10 (23.3)23 (48.9)6 (13.3)6 (12.0)
 Anorexia1 (2.2)2 (4.3)2 (4.7)3 (6.3)10 (23.8)7 (16.3)15 (31.9)3 (6.7)5 (10.0)
 Decreased appetite0 (0.0)0 (0.0)0 (0.0)1 (2.1)0 (0.0)2 (4.7)8 (17.0)1 (2.2)1 (2.0)
Musculoskeletal/connective tissue disorders2 (4.3)5 (10.6)2 (4.7)3 (6.3)2 (4.8)3 (7.0)4 (8.5)2 (4.4)2 (4.0)
Investigations1 (2.2)1 (2.1)1 (2.3)1 (2.1)0 (0.0)3 (7.0)2 (4.3)1 (2.2)3 (6.0)
Vascular disorders4 (8.7)2 (4.3)0 (0.0)2 (4.2)1 (2.4)1 (2.3)2 (4.3)2 (4.4)3 (6.0)
 Hypertension4 (8.7)1 (2.1)0 (0.0)2 (4.2)1 (2.4)1 (2.3)1 (2.1)1 (2.2)2 (4.0)
Injury/poisoning/procedural complications4 (8.7)1 (2.1)2 (4.7)2 (4.2)0 (0.0)1 (2.3)4 (8.5)1 (2.2)0 (0.0)
Skin and subcutaneous disorders0 (0.0)3 (6.4)1 (2.3)3 (6.3)1 (2.4)0 (0.0)1 (2.1)2 (4.4)2 (4.0)
Respiratory, thoracic, and mediastinal disorders3 (6.5)1 (2.1)1 (2.3)1 (2.1)2 (4.8)1 (2.3)1 (2.1)2 (4.4)2 (4.0)
Eye disorders3 (6.5)1 (2.1)0 (0.0)1 (2.1)1 (2.4)0 (0.0)1 (2.1)3 (6.7)4 (8.0)
 Diabetic retinopathy0 (0.0)0 (0.0)0 (0.0)0 (0.0)1 (2.4)0 (0.0)0 (0.0)0 (0.0)3 (6.0)
Cardiac disorders2 (4.3)1 (2.1)4 (9.3)2 (4.2)0 (0.0)1 (2.3)1 (2.1)1 (2.2)0 (0.0)
Psychiatric disorders1 (2.2)3 (6.4)0 (0.0)2 (4.2)0 (0.0)0 (0.0)1 (2.1)0 (0.0)0 (0.0)
Blood/lymphatic system disorders0 (0.0)0 (0.0)0 (0.0)3 (6.3)1 (2.4)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  • Data are reported as the number (n) of randomized patients exposed to at least one dose of trial product and the percentage (%) of patients experiencing at least one AE.