Table 2

Safety outcomes in BUILDER-1 part 1 (week 12, safety population)

Placebo
n=51
TCZ 8 mg/kg
n=51
Total PY11.9011.43
AEs
 AEs, n2730
 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, n02
 Patients with ≥1 SAE, n (%)02 (3.9)
 SAE rate/100 PY (95% CI)017.5 (2.1 to 63.2)
AEs leading to withdrawal, n00
Deaths, n00
  • AE, adverse event; PY, patient-year; SAE, serious adverse event; TCZ, tocilizumab.