Table 1 |
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|
Serious adverse events reported at a rate of ≥ 0.3 per 100 patient-years in any group (all-control population) |
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|
All-control population n = 4,199 |
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|
Control n = 1,555 |
Tocilizumab 4 mg/kg + DMARDs n = 774 |
Tocilizumab 8 mg/kg + DMARDs n = 1,870 |
|
|
|
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|
Rate per 100 PY (number of events) |
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|
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) |
-- |
|
|
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|
DMARD, disease-modifying antirheumatic drug; PY, patient-years. |
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|
Schiff et al. Arthritis Research & Therapy 2011 13:R141 doi:10.1186/ar3455 |
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