Tocilizumab exposure (N=417; 407.0 PYs) | ||||||
---|---|---|---|---|---|---|
Adverse events* | Serious adverse events* | |||||
Patients, n (%) | Events, n | Rate/100 PYs | Patients, n (%) | Events, n | Rate/100 PYs | |
Total events | 289 (69.3) | 913 | 224.3 | 117 (28.1) | 222 | 54.5 |
Infections and infestations | 171 (41.0) | 284 | 69.8 | 55 (13.2) | 74 | 18.2 |
Gastroenteritis | 30 (7.2) | 32 | 7.9 | 8 (1.9) | 9 | 2.2 |
Influenza | 30 (7.2) | 33 | 8.1 | 3 (0.7) | 3 | 0.7 |
Bronchitis | 24 (5.8) | 34 | 8.4 | 4 (1.0) | 6 | 1.5 |
Pharyngitis | 22 (5.3) | 37 | 9.1 | 1 (0.2) | 1 | 0.2 |
Nasopharyngitis | 22 (5.3) | 29 | 7.1 | 0 (0.0) | 0 | 0.0 |
Respiratory, thoracic and mediastinal disorders | 82 (19.7) | 142 | 34.9 | 8 (1.9) | 9 | 2.2 |
Upper respiratory tract inflammation | 71 (17.0) | 118 | 29.0 | 1 (0.2) | 1 | 0.2 |
Investigations | 44 (10.6) | 80 | 19.7 | 13 (3.1) | 18 | 4.4 |
Musculoskeletal and connective tissue disorders | 59 (14.1) | 69 | 17.0 | 15 (3.6) | 17 | 4.2 |
Juvenile idiopathic arthritis | 36 (8.6) | 40 | 9.8 | 14 (3.4) | 16 | 3.9 |
Blood and lymphatic system disorders | 46 (11.0) | 57 | 14.0 | 34 (8.2) | 40 | 9.8 |
Haematophagic histiocytosis | 24 (5.8) | 26 | 6.4 | 24 (5.8) | 26 | 6.4 |
Gastrointestinal disorders | 42 (10.1) | 56 | 13.8 | 10 (2.4) | 15 | 3.7 |
Skin and subcutaneous tissue disorders | 38 (9.1) | 43 | 10.6 | 3 (0.7) | 3 | 0.7 |
Hepatobiliary disorders | 35 (8.4) | 41 | 10.1 | 9 (2.2) | 9 | 2.2 |
Hepatic function abnormal | 29 (7.0) | 33 | 8.1 | 6 (1.4) | 6 | 1.5 |
General disorders and administration site conditions | 24 (5.8) | 32 | 7.9 | 7 (1.7) | 9 | 2.2 |
Injury, poisoning and procedural complications | 27 (6.5) | 32 | 7.9 | 9 (2.2) | 11 | 2.7 |
Eye disorders | 12 (2.9) | 18 | 4.4 | 0 (0.0) | 0 | 0.0 |
Vascular disorders | 14 (3.4) | 17 | 4.2 | 3 (0.7) | 4 | 1.0 |
Metabolism and nutrition disorders | 12 (2.9) | 14 | 3.4 | 0 (0.0) | 0 | 0.0 |
Nervous system disorders | 12 (2.9) | 12 | 2.9 | 7 (1.7) | 7 | 1.7 |
Renal and urinary disorders | 7 (1.7) | 7 | 1.7 | 4 (1.0) | 4 | 1.0 |
Immune system disorders | 5 (1.2) | 5 | 1.2 | 1 (0.2) | 1 | 0.2 |
Cardiac disorders | 3 (0.7) | 3 | 0.7 | 1 (0.2) | 1 | 0.2 |
Surgical and medical procedures | 1 (0.2) | 1 | 0.2 | 0 (0.0) | 0 | 0.0 |
*Adverse events and serious adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA, V.16.1).
PYs, patient-years, SOC, system organ class.