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
 Deaths31.610.5
Serious related AEs137.0137.0
AEs experienced by >5% of patients in either group (by preferred term)
 Nasopharyngitis4624.64423.5
 Upper respiratory tract infection1910.22211.8
 Arthralgia147.584.3
 Headache147.563.2
 Back pain126.4105.3
 Hepatic function abnormal126.463.2
 Constipation115.942.1
 Abdominal pain upper105.352.7
 Injection site erythema105.34725.1
 Injection site pruritus73.73820.3
 Latent tuberculosis52.7105.3
 Cough52.7147.5
 Injection site swelling42.1137.0
  • AEs, adverse events; ETN-RP, etanercept reference product.