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Table 2 All-causality treatment-emergent adverse events (safety population)

From: A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis

  PF-06410293
n = 297
Adalimumab-EU
n = 299
Number of AEs 343 379
Patients with events, n (%)
 AEs 143 (48.1) 143 (47.8)
 SAEs 12 (4.0) 13 (4.3)
 Grade 3 AEs 15 (5.1) 16 (5.4)a
 Grade 4 AEs 2 (0.7) 4 (1.3)
 Grade 5 AEs 0 1 (0.3)
Patients with temporary treatment discontinuation due to AEs, n (%) 17 (5.7) 29 (9.7)
Patients discontinued from treatment due to AEsc, n (%) 11 (3.7)b 14 (4.7)
Patients discontinued from the study due to AEs, n (%) 8 (2.7) 9 (3.0)
  1. AEs were graded in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Grade 1–5 AEs are defined as mild, moderate, severe, life-threatening AEs, and death related to AE, respectively.
  2. Abbreviations: Adalimumab-EU adalimumab sourced from the European Union, AE adverse event, SAE serious adverse event
  3. aOne patient had an AE of neutropenia incorrectly recorded as grade 2; the correct severity was grade 3 (not corrected in this table)
  4. bOne patient was incorrectly recorded as treatment discontinuation due to an AE; the correct reason was insufficient clinical response (not corrected in this table)
  5. cThe System Organ Class with the highest proportion of subjects who had AEs leading to permanent treatment discontinuation was infections and infestations (8 [2.7%] subjects on PF-06410293 and 3 [1.0%] subjects on adalimumab-EU)