Table 7.
Infections, serious infections and cardiovascular events.
| Initially randomized population n = 4199 (rates/100 PY) | All exposed population n = 4009 (rates/100 PY) | |||
|---|---|---|---|---|
| Controls | TCZ 4 mg/kg + | TCZ 8 mg/kg + | ||
| n = 15,555 | DMARDs n = 774 | DMARDs n = 1870 | ||
| Overall AEs and infections | ||||
| All AEs | 339.0 | 358.0 | 381.6 | 278.2 |
| Infections | 95.9 | 101.8 | 102.3 | 108.01 |
| SAEs | 14.4 | 13.6 | 14.5 | 14.4 |
| Serious infections | 3.4 | 3.5 | 4.9 | 4.7 |
| Cardiovascular events | ||||
| MI | 0.49 (4) | 0.18(1) | 0.17 (2) | 0.25 (24) |
| Stroke | 0.24 (2) | 0 (0) | 0.33 (4) | 0.19 (4) |
PY, per year; TCZ, tocilizumab; DMARD, disease-modifying antirheumatic drug; AE, adverse event; SAE, serious adverse event; MI, myocardial infarction.