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Table 4 Prespecified treatment-emergent adverse event categories of interest with risk difference (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

Category PF-06410293
n = 297
n (%)
Adalimumab-EU
n = 299
n (%)
Risk difference
(95% CI) (%)
Blood and lymphatic system events 22 (7.4) 14 (4.7) 2.73 (−1.15, 6.79)
Cardiovascular events 9 (3.0) 16 (5.4) −2.32 (−5.84, 0.96)
Demyelinating conditions 0 0 0 (NA)
Gastric/hepatic events 11 (3.7) 14 (4.7) −0.98 (−4.44, 2.39)
Hypersensitivitya 13 (4.4) 25 (8.4) −3.98 (−8.15, −0.06)
Infections and infestations 74 (24.9) 75 (25.1) −0.17 (−7.13, 6.80)
Neoplasms 5 (1.7) 5 (1.7) 0.01 (−2.38, 2.42)
Otherb 11 (3.7) 10 (3.3) 0.36 (−2.80, 3.57)
  1. Abbreviations: Adalimumab-EU adalimumab sourced from the European Union, CI confidence interval, MedDRA Medical Dictionary for Regulatory Activities, NA not applicable
  2. aHypersensitivity events identified by Hypersensitivity Standardized MedDRA Query (broad and narrow), Anaphylactic reactions Standardized MedDRA Query (broad and narrow), and High-Level Group Terms Immunology and allergy investigations
  3. bOther events identified by High-Level Group Terms Skin Vascular Abnormalities, Central Nervous System Vascular Abnormalities and Medication Errors; Higher Level Terms Connective Tissue Disorders, Vasculitides (not elsewhere classified), Rashes, Eruptions and Exanthems (not elsewhere classified); Lower Level Teams Seizure and Convulsions; and Preferred Terms Lupus-like Syndrome, Headache and Migraine