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Table 2 Any TEAEs and treatment-related TEAEs with a ≥ 2% incidence in any of the treatment groups (TP2 safety set)

From: Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study

Preferred term Continued SDZ ETN (n = 175) n (%) Switched to SDZ ETN (n = 166) n (%)
TEAEs
 Nasopharyngitis 13 (7.4) 9 (5.4)
 Upper respiratory tract infection 9 (5.1) 9 (5.4)
 Urinary tract infection 7 (4.0) 2 (1.2)
 Alanine aminotransferase increased 4 (2.3) 6 (3.6)
 Injection site reaction 0 6 (3.6)
 Headache 0 4 (2.4)
Treatment-related TEAEs
 Nasopharyngitis 5 (2.9) 0
 Injection site reaction 0 6 (3.6)
  1. A patient with multiple occurrences of event within the same system organ class or preferred term under one treatment is counted only once. TEAEs are events started after the first dose of study treatment and before study discontinuation or 30 days after last dose, whichever occurs later. Events are listed by descending order of occurrence in the “continued SDZ ETN” group
  2. Adverse event terms are coded using MedDRA version 19.1
  3. ETN reference etanercept, MedDRA medical dictionary for regulatory activities, SDZ ETN Sandoz etanercept, TEAE treatment-emergent adverse event