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Table 2 Adverse events during the extension study (safety analysis set)

From: Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

  Maintenance group (n = 70) Switch group (n = 78)
Number % Number %
All AEs 49 70.0 55 70.5
All ADRs 20 28.6 26 33.3
Serious AEs 6 8.6 8 10.3
Serious ADRs 3 4.3 4 5.1
Any AEs leading to discontinuation 1 1.4 3 3.8
Any AEs leading to temporary drug interruption 13 18.6 8 10.3
AEs experienced by ≥ 5% of patients in either group (by preferred term)
 Upper respiratory tract infection 4 5.7 9 11.5
 Nasopharyngitis 7 10.0 4 5.1
 Arthralgia 3 4.3 8 10.3
 Cough 3 4.3 4 5.1
Active tuberculosis 0 0 0 0
Injection site reaction 1 1.4 5 6.4
  1. ADR adverse drug reaction, AE adverse event