Table 1

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

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)

--


DMARD, disease-modifying antirheumatic drug; PY, patient-years.

Schiff et al. Arthritis Research & Therapy 2011 13:R141   doi:10.1186/ar3455

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