Table 3 Summary of adverse events by severity and relationship to study treatment (safety analysis set)
AEs occurring in >0.5% of patients, No. (%) | Mild | Moderate | Severe | Related to study drug | Total |
|---|---|---|---|---|---|
Infections and infestations | 228 (7.6) | 40 (1.3) | 9 (0.3) | 2 (0.1) | 277 (9.3) |
 Upper respiratory tract infection | 100 (3.3) | 8 (0.3) | 1 (0.0) | 0 | 109 (3.6) |
 Bronchitis | 30 (1.0) | 4 (0.1) | 0 | 0 | 34 (1.1) |
 Conjunctivitis | 24 (0.8) | 5 (0.2) | 0 | 0 | 29 (1.0) |
Gastrointestinal disorders | 204 (6.8) | 34 (1.1) | 9 (0.3) | 41 (1.4) | 247 (8.3) |
 Constipation | 36 (1.2) | 5 (0.2) | 2 (0.1) | 8 (0.3) | 43 (1.4) |
 Diarrhoea | 26 (0.9) | 6 (0.2) | 0 | 4 (0.1) | 32 (1.1) |
Metabolism disorders | 183 (6.1) | 22 (0.7) | 11 (0.4) | 56 (1.9) | 216 (7.2) |
 Hyperlipidaemia | 34 (1.1) | 1 (0.0) | 0 | 2 (0.1) | 35 (1.2) |
 Hyperuricaemia | 31 (1.0) | 2 (0.1) | 0 | 0 | 33 (1.1) |
 Hypoglycaemia | 31 (1.0) | 0 | 0 | 19 (0.6) | 31 (1.0) |
Renal and urinary disorders | 126 (4.2) | 15 (0.5) | 2 (0.1) | 74 (2.5) | 143 (4.8) |
 Urinary tract infection | 56 (1.9) | 7 (0.2) | 0 | 49 (1.6) | 63 (2.1) |
Musculoskeletal and connective tissue disorders | 117 (3.9) | 22 (0.7) | 1 (0.0) | 8 (0.3) | 140 (4.7) |
Nervous system disorders | 115 (3.8) | 18 (0.6) | 4 (0.1) | 7 (0.2) | 137 (4.6) |
 Dizziness | 35 (1.2) | 1 (0.0) | 0 | 2 (0.1) | 36 (1.2) |
Reproductive system and breast disorders | 85 (2.8) | 12 (0.4) | 1 (0.0) | 45 (1.5) | 98 (3.3) |
Investigations | 75 (2.5) | 7 (0.2) | 1 (0.0) | 35 (1.2) | 83 (2.8) |
General administration site conditions disorders | 70 (2.3) | 10 (0.3) | 2 (0.1) | 21 (0.7) | 82 (2.7) |
Skin and subcutaneous tissue disorders | 70 (2.3) | 9 (0.3) | 0 | 10 (0.3) | 79 (2.6) |
Eye disorders | 56 (1.9) | 9 (0.3) | 4 (0.1) | 1 (0.0) | 69 (2.3) |
Cardiac disorders | 42 (1.4) | 13 (0.5) | 5 (0.2) | 3 (0.1) | 60 (2.0) |