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Table 1 Serious adverse events reported at a rate of ≥ 0.3 per 100 patient-years in any group (all-control population)

From: Integrated safety in tocilizumab clinical trials

  All-control population
n= 4,199
  Control
n= 1,555
Tocilizumab
4 mg/kg + DMARDs
n= 774
Tocilizumab
8 mg/kg + DMARDs
n= 1,870
Rate per 100 PY (number of events)
Pneumonia 0.6 (5) 0.7 (4) 0.9 (11)
Cellulitis 0.2 (2) -- 0.9 (11)
Gastroenteritis 0.2 (2) 0.5 (3) 0.1 (1)
Urinary tract infection 0.5 (4) 0.2 (1) 0.1 (1)
Sepsis 0.1 (1) 0.4 (2) 0.2 (2)
Herpes zoster 0.1 (1) -- 0.3 (4)
Fall 0.1 (1) -- 0.3 (4)
Pulmonary embolism 0.2 (2) -- 0.3 (3)
Basal cell carcinoma 0.1 (1) 0.4 (2) 0.1 (1)
Spinal compression fracture 0.1 (1) -- 0.3 (3)
Coronary artery disease -- 0.2 (1) 0.3 (3)
Back pain 0.1 (1) -- 0.3 (3)
Rheumatoid arthritis 0.4 (3) -- --
Gastroenteritis viral 0.1 (1) 0.4 (2) --
Prostate cancer 0.1 (1) 0.4 (2) --
Neutropenia -- 0.4 (2) 0.1 (1)
Syncope -- 0.4 (2) --
Tendon rupture -- 0.4 (2) --
Interstitial lung disease -- 0.4 (2) --
Anaphylactic reaction -- 0.4 (2) --
  1. DMARD, disease-modifying antirheumatic drug; PY, patient-years.