Table 2 Summary of safety data up to 288Â 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 | Â |
 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 | Â |
 Fall | 71 (14.6) |
 Contusion | 49 (10.1) |
Metabolism and nutrition disorders | Â |
 Hyperlipidaemia | 56 (11.5) |
Vascular disorders | Â |
 Hypertension | 55 (11.3) |
Gastrointestinal disorders | Â |
 Dental caries | 54 (11.1) |
 Constipation | 43 (8.8) |
 Diarrhoea | 33 (6.8) |
 Stomatitis | 32 (6.6) |
 Gastritis | 26 (5.3) |
Nervous system disorders | Â |
 Headache | 48 (9.9) |
Musculoskeletal and connective tissue disorders | Â |
 Back pain | 46 (9.5) |
Investigations | Â |
 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 | Â |
 Upper respiratory tract inflammation | 34 (7.0) |
 Cough | 33 (6.8) |
Skin and subcutaneous tissue disorders | Â |
 Eczema | 27 (5.6) |
Blood and lymphatic system disorders | Â |
 Anaemia | 26 (5.3) |