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) |
Patients were counted only once within an SOC and PT; if a patient reported multiple AEs within an SOC or PT, the most serious AE (for severity assessment) and the most frequent AE related to study drug (for assessment of relationship with study drug) were included. AEs are coded using MedDRA, version 23.1
AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, PT preferred term, SOC system organ class