Table 2

AEs during the entire study period and AEs experienced by >5% of patients in either group during the entire study period

LBEC0101 (n=187)ETN-RP (n=187)
PatientsIncidence (%)PatientsIncidence (%)
All AEs17292.017392.5
All related AEs9651.311662.0
Serious AEs3116.62010.7
Serious related AEs137.0137.0
AEs experienced by >5% of patients in either group (by preferred term)
 Upper respiratory tract infection1910.22211.8
 Back pain126.4105.3
 Hepatic function abnormal126.463.2
 Abdominal pain upper105.352.7
 Injection site erythema105.34725.1
 Injection site pruritus73.73820.3
 Latent tuberculosis52.7105.3
 Injection site swelling42.1137.0
  • AEs, adverse events; ETN-RP, etanercept reference product.