Table 2.
Summary of safety data up to 288 weeks of observation in 486 patients
| Variable | Number (%) |
|---|---|
| All AEs | 476 (97.9) |
| Serious AEs | 139 (28.6) |
| Discontinuations due to AEs | 118 (24.3) |
| Discontinuations due to serious AEs | 75 (15.4) |
| Dose reduction or temporary discontinuation due to AEs | 261 (53.7) |
| Infections and infestations | |
| Nasopharyngitis | 293 (60.3) |
| Herpes zoster | 94 (19.3) |
| Bronchitis | 51 (10.5) |
| Upper respiratory tract infection | 48 (9.9) |
| Influenza | 48 (9.9) |
| Cystitis | 46 (9.5) |
| Pharyngitis | 46 (9.5) |
| Gastroenteritis | 46 (9.5) |
| Tinea pedis | 34 (7.0) |
| Oral herpes | 33 (6.8) |
| Injury, poisoning or procedural complications | |
| Fall | 71 (14.6) |
| Contusion | 49 (10.1) |
| Metabolism and nutrition disorders | |
| Hyperlipidaemia | 56 (11.5) |
| Vascular disorders | |
| Hypertension | 55 (11.3) |
| Gastrointestinal disorders | |
| Dental caries | 54 (11.1) |
| Constipation | 43 (8.8) |
| Diarrhoea | 33 (6.8) |
| Stomatitis | 32 (6.6) |
| Gastritis | 26 (5.3) |
| Nervous system disorders | |
| Headache | 48 (9.9) |
| Musculoskeletal and connective tissue disorders | |
| Back pain | 46 (9.5) |
| Investigations | |
| Lymphocyte count decreased | 38 (7.8) |
| White blood cell count decreased | 27 (5.6) |
| Alanine aminotransferase increased | 27 (5.6) |
| Respiratory, thoracic and mediastinal disorders | |
| Upper respiratory tract inflammation | 34 (7.0) |
| Cough | 33 (6.8) |
| Skin and subcutaneous tissue disorders | |
| Eczema | 27 (5.6) |
| Blood and lymphatic system disorders | |
| Anaemia | 26 (5.3) |
Treatment-emergent adverse events (AEs) affecting ≥5 % of patients in the total population (all causalities) according to Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class and MedDRA (v16.1) preferred term. Data are number (%)