Table 2

Overview of adverse events and serious adverse events (SOC and preferred term >5%)

 Tocilizumab exposure
(N=417; 407.0 PYs)
Adverse events*Serious adverse events*
Patients,
n (%)
Events,
n
Rate/100 PYsPatients,
n (%)
Events,
n
Rate/100 PYs
Total events289 (69.3)913224.3117 (28.1)22254.5
Infections and infestations171 (41.0)28469.855 (13.2)7418.2
 Gastroenteritis30 (7.2)327.98 (1.9)92.2
 Influenza30 (7.2)338.13 (0.7)30.7
 Bronchitis24 (5.8)348.44 (1.0)61.5
 Pharyngitis22 (5.3)379.11 (0.2)10.2
 Nasopharyngitis22 (5.3)297.10 (0.0)00.0
Respiratory, thoracic and mediastinal disorders82 (19.7)14234.98 (1.9)92.2
 Upper respiratory tract inflammation71 (17.0)11829.01 (0.2)10.2
Investigations44 (10.6)8019.713 (3.1)184.4
Musculoskeletal and connective tissue disorders59 (14.1)6917.015 (3.6)174.2
 Juvenile idiopathic arthritis36 (8.6)409.814 (3.4)163.9
Blood and lymphatic system disorders46 (11.0)5714.034 (8.2)409.8
  Haematophagic histiocytosis24 (5.8)266.424 (5.8)266.4
Gastrointestinal disorders42 (10.1)5613.810 (2.4)153.7
Skin and subcutaneous tissue disorders38 (9.1)4310.63 (0.7)30.7
Hepatobiliary disorders35 (8.4)4110.19 (2.2)92.2
 Hepatic function abnormal29 (7.0)338.16 (1.4)61.5
General disorders and administration site conditions24 (5.8)327.97 (1.7)92.2
Injury, poisoning and procedural complications27 (6.5)327.99 (2.2)112.7
Eye disorders12 (2.9)184.40 (0.0)00.0
Vascular disorders14 (3.4)174.23 (0.7)41.0
Metabolism and nutrition disorders12 (2.9)143.40 (0.0)00.0
Nervous system disorders12 (2.9)122.97 (1.7)71.7
Renal and urinary disorders7 (1.7)71.74 (1.0)41.0
Immune system disorders5 (1.2)51.21 (0.2)10.2
Cardiac disorders3 (0.7)30.71 (0.2)10.2
Surgical and medical procedures1 (0.2)10.20 (0.0)00.0
  • *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.