AEs overall and by SOC
| RA | PsA | AS | Total | |
| n=524 (100.0%) | n=546 (100.0%) | n=543 (100.0%) | n=1613 (100.0%) | |
| Patient years | 597.3 | 690.5 | 704.1 | 1991.9 |
| AEs total | ||||
| Patients n (%)/events per 100 patient years | 320 (61.1)/127.6 | 309 (56.6)/106.2 | 281 (51.7)/89.5 | 910 (56.4)/106.7 |
| SAEs | ||||
| Patients n (%)/events per 100 patient years | 75 (14.3)/19.8 | 70 (12.8)/15.1 | 59 (10.9)/11.9 | 204 (12.6)/15.4 |
| AEs sorted by SOC | Patients n (%)/events per 100 patient years | |||
| General disorders and administration site conditions | 171 (32.6)/33.3 | 155 (28.4)/25.3 | 124 (22.8)/21.0 | 450 (27.9)/26.2 |
| Infections and infestations | 83 (15.8)/20.8 | 92 (16.8)/20.4 | 88 (16.2)/16.2 | 263 (16.3)/19.0 |
| Skin and subcutaneous tissue disorders | 44 (8.4)/9.0 | 51 (9.3)/9.1 | 55 (10.1)/9.8 | 150 (9.3)/9.3 |
| Surgical and medical procedures | 40 (7.6)/8.5 | 38 (7.0)/5.9 | 26 (4.8)/4.1 | 104 (6.4)/6.1 |
| Gastrointestinal disorders | 29 (5.5)/7.4 | 40 (7.3)/8.7 | 32 (5.9)/6.0 | 101 (6.3)/7.3 |
| Musculoskeletal and connective tissue disorders | 39 (7.4)/8.9 | 22 (4.0)/4.3 | 40 (7.4)/7.8 | 101 (6.3)/6.9 |
| Nervous system disorders | 39 (7.4)/8.9 | 29 (5.3)/5.1 | 27 (5.0)/4.4 | 95 (5.9)/6.0 |
| Investigations | 18 (3.4)/4.4 | 29 (5.3)/5.4 | 21 (3.9)/3.8 | 68 (4.2)/4.5 |
| Respiratory, thoracic and mediastinal disorders | 29 (5.5)/6.7 | 24 (4.4)/3.9 | 15 (2.8)/2.4 | 68 (4.2)/4.2 |
| Injury, poisoning and procedural complications | 19 (3.6)/3.7 | 17 (3.1)/3.5 | 16 (2.9)/2.4 | 52 (3.2)/3.2 |
| Vascular disorders | 15 (2.9)/3.0 | 13 (2.4)/1.9 | 10 (1.8)/1.6 | 38 (2.4)/2.1 |
| Psychiatric disorders | 9 (1.7)/1.5 | 12 (2.2)/2.2 | 12 (2.2)/1.9 | 33 (2.0)/1.9 |
| Cardiac disorders | 14 (2.7)/2.5 | 10 (1.8)/1.9 | 7 (1.3)/1.1 | 31 (1.9)/1.8 |
| Eye disorders | 10 (1.9)/1.8 | 3 (0.5)/0.7 | 12 (2.2)/2.3 | 25 (1.5)/1.6 |
| Neoplasms benign, malignant and unspecified (incl. cysts and polyps) | 10 (1.9)/2.0 | 7 (1.3)/1.2 | 5 (0.9)/0.7 | 22 (1.4)/1.3 |
| Metabolism and nutrition disorders | 6 (1.1)/1.0 | 7 (1.3)/1.2 | 4 (0.7)/0.6 | 17 (1.1)/0.9 |
| Reproductive system and breast disorders | 3 (0.6)/0.5 | 8 (1.5)/1.2 | 5 (0.9)/0.7 | 16 (1.0)/0.8 |
| Blood and lymphatic system disorders | 5 (1.0)/0.8 | 6 (1.1)/1.9 | 3 (0.6)/0.6 | 14 (0.9)/1.1 |
| Renal and urinary disorders | 5 (1.0)/1.0 | 4 (0.7)/0.9 | 6 (1.1)/0.9 | 15 (0.9)/0.9 |
| Ear and labyrinth disorders | 4 (0.8)/0.7 | 6 (1.1)/0.9 | 5 (0.9)/0.7 | 15 (0.9)/0.8 |
| Immune system disorders | 5 (1.0)/1.6 | 1 (0.2)/0.1 | 2 (0.4)/0.4 | 8 (0.5)/0.5 |
| Hepatobiliary disorders | 0 (0.0)/0.0 | 4 (0.7)/0.6 | 0 (0.0)/0.0 | 4 (0.2)/0.2 |
| Endocrine disorders | 1 (0.2)/0.2 | 0 (0.0)/0.0 | 1 (0.2)/0.1 | 2 (0.1)/0.1 |
Numbers and percentages are based on the safety population (n=1613).
Categorisation by Medical Dictionary for Regulatory Activities (MedDRA) V.13.1.
AE, adverse event; AS, ankylosing spondylitis; PsA, psoriatic arthritis; RA, rheumatoid arthritis; SAE, serious adverse event; SOC, System Organ Class.