Placebo n=51 | TCZ 8 mg/kg n=51 | |
---|---|---|
Total PY | 11.90 | 11.43 |
AEs | ||
AEs, n | 27 | 30 |
Patients with ≥1 AE, n (%) | 13 (25.5) | 20 (39.2) |
AE rate/100 PY (95% CI) | 226.9 (149.5 to 330.2) | 262.4 (177.0 to 374.6) |
SAEs | ||
SAEs, n | 0 | 2 |
Patients with ≥1 SAE, n (%) | 0 | 2 (3.9) |
SAE rate/100 PY (95% CI) | 0 | 17.5 (2.1 to 63.2) |
AEs leading to withdrawal, n | 0 | 0 |
Deaths, n | 0 | 0 |
AE, adverse event; PY, patient-year; SAE, serious adverse event; TCZ, tocilizumab.