Table 2.

Adverse events (AE; safety population).

All-control Population, n = 4199All-exposed Population (cutoff date: Feb. 17, 2010), n = 4009
Control, n = 1555TCZ 4 mg/kg + DMARD/MTX, n = 774TCZ 8 mg/kg ± DMARD/MTX, n = 1870Overall0–12 Mo13–24 Mo25–36 Mo> 36 Mo
Total duration, PY824.6564.61194.112293.13470.93026.12732.73063.5
AE, rate/100 PY
  Led to withdrawala6.910.
  Led to dose modification/interruptiona27.832.934.236.040.338.538.736.8
Serious AE, rate/100 PY Anya14.413.614.514.115.513.414.813.6
Death rate/100 PY0.730.000.750.450.550.330.440.29
AE with rate ≥ 2/100 PY by SOCa
  Infections and infestations87.993.993.468.796.783.880.873.7
  Gastrointestinal disorders55.347.356.832.755.032.829.323.9
  Musculoskeletal and connective tissue disorders38.830.329.127.534.731.127.825.2
  Nervous system disorders20.521.424.012.822.413.010.68.9
  Skin and subcutaneous disorders19.629.431.715.627.314.512.010.8
  General disorders and administrative site conditions18.217.518.
  Respiratory, thoracic, and mediastinal disorders14.818.417.511.817.112.311.010.1
  Injury, poisoning, and procedural complications13.915.815.814.516.915.114.313.7
  Vascular disorders10.314.212.48.413.
  Psychiatric disorders7.
  Metabolism and nutrition disorders6.
  Blood and lymphatic disorders5.
  Eye disorders5.
  Renal and urinary disorders4.
  Reproductive and breast disorders4.
  Cardiac disorders3.
  Ear and labyrinth disorders3.
  Neoplasms benign, malignant, unspecified (including cysts and polyps)
  Immune disorders1.
  Hepatobiliary disorders1.
SAE with rate ≥ 1/100 PY by SOCa
  Infections and infestations3.
  Gastrointestinal disorders1.
  Musculoskeletal and connective tissue disorders1.
  Nervous system disorders0.
  Injury, poisoning, and procedural complications1.
Cardiac disorders1.
Neoplasms, benign, malignant, unspecified (including cysts and polyps)
  • a Multiple occurrences of the same AE in a patient are counted once in each period.

  • b Intensity of AE graded by the investigator as mild, moderate, or severe. PY: patient-years; SAE: serious adverse event; SOC: system organ class; TCZ: tocilizumab; DMARD: disease-modifying antirheumatic drug; MTX: methotrexate.