Table 3.
Serious adverse events | Tocilizumab exposure (N=417; 407.0 PYs) | ||
---|---|---|---|
Patients, n (%) | Events, n | Rate/100 PYs | |
Serious infections | 55 (13.2) | 74 | 18.2 |
Bacterial pneumonia | 10 (2.4) | 12 | 2.9 |
Gastroenteritis | 8 (1.9) | 9 | 2.2 |
Bronchitis | 4 (1.0) | 6 | 1.5 |
Cellulitis | 3 (0.7) | 3 | 0.7 |
Sepsis | 3 (0.7) | 3 | 0.7 |
Herpes zoster | 3 (0.7) | 3 | 0.7 |
Influenza | 3 (0.7) | 3 | 0.7 |
Pneumocystis jirovecii pneumonia | 2 (0.5) | 2 | 0.5 |
Varicella | 2 (0.5) | 2 | 0.5 |
Macrophage activation syndrome | 24 (5.8) | 26 | 6.4 |
Serious infusion-related reactions | 8 (1.9) | 14 | 3.4 |
PYs, patient-years.