Table 2

 Selected serious adverse events per 100 patient-years (100 PYs) by subgroup*

All patients (n = 6610) PYs = 4210No concomitant DMARDs (n = 1731) PYs = 1041Concomitant DMARDs (n = 4879) PYs = 3169
DMARDs, disease-modifying antirheumatic drugs; MedDRA, Medical Dictionary for Regulatory Activities.
*MedDRA System Organ Class term.
†MedDRA High Level Group term.
‡MedDRA High Level term.
§Includes all neoplasms not explicitly reported as benign.
All serious adverse events28.440.024.6
    Blood and lymphatic system disorders*
Anaemias (non-haemolytic and marrow depression)†
Cardiac disorders*
    Heart failures†
Gastrointestinal disorders*
General disorders and administration site conditions*
Hepatobiliary disorders*
Immune system disorders*
    Allergic conditions†
Infections and infestations*
    Lower respiratory tract and lung infections‡
    Abdominal and gastrointestinal infections‡
    Sepsis, bacteraemia and viraemia‡
    Bone and joint‡
Injury, poisoning and procedural complications*
Musculoskeletal and connective tissue disorders*6.911.05.5
    Joint disorders†
Neoplasm benign, malignant, and unspecified (including cysts and polyps)*
Nervous system disorders*
Renal and urinary disorders*
Reproductive system and breast disorders*
Respiratory, thoracic, and mediastinal disorders*
    Parenchymal lung disorders (not elsewhere classified)‡
Skin and subcutaneous tissue disorders*
Surgical and medical procedures*
Vascular disorders*