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Table 4 Treatment-emergent adverse events reported for ≥3 participants in either treatment group in Study 1 and Study 2

From: Comparison of two biosimilarity studies of FKB327 with the adalimumab reference product: randomized phase 1 studies of single-blind, single-dose subcutaneous injection in healthy Japanese male participants

  Study 1 Study 2
FKB327
N = 65
RP
N = 65
FKB327
N = 65
RP
N = 65
Participants with ≥1 TEAEs, n (%) 25 (38.5) 29 (44.6) 20 (30.8) 31 (47.7)
Participants with ≥1 TESAEs, n (%) 0 0 0 1 (1.5)
Participants in either group with ≥3TEAEs
 Injection-site reaction, n (%) 3 (4.6) 9 (13.8) 9 (13.8) 13 (20.0)
 Nasopharyngitis, n (%) 9 (13.8) 8 (12.3) 3 (4.6) 8 (12.3)
 Headache, n (%) 7 (10.8) 4 (6.2) 1 (1.5) 0
 Rash, n (%) 1 (1.5) 0 2 (3.1) 3 (4.6)
 Diarrhea, n (%) 1 (1.5) 1 (1.5) 2 (3.1) 3 (4.6)
 Alanine aminotransferase increased, n (%) 0 0 3 (4.6) 2 (3.1)
 Arthralgia, n (%) 0 0 3 (4.6) 1 (1.5)
  1. RP Reference product; TEAE Treatment-emergent adverse event; TESAE Treatment-emergent serious adverse event