Table 1 Serious adverse events reported at a rate of ≥ 0.3 per 100 patient-years in any group (all-control population)
| Â | All-control population n= 4,199 | ||
|---|---|---|---|
| Â | 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) | -- |