Skip to main content

Advertisement

Springer Nature is making Coronavirus research free. View research | View latest news | Sign up for updates

Table 3 Summary of information relating to the adverse effects in the treatment arms

From: A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis

Adverse effects (AE)   Number (%)
Organ systems Type CinnoRA® Humira®
Patients with at least one AE, total* 24 (35.29) 30 (44.12)
Dermatologic Hives 2 (2.94) 5 (7.35)
Swelling
Rash
Local Inject site react., erythema 6 (8.82) 12 (17.65)
Inject site react., itching
Inject site react., hemorrhage
Inject site react., swelling
Inject site react., pain
Respiratory Sinusitis 6 (8.82) 14 (20.59)
Flu-like syndrome
Difficulty breathing
Respiratory infection
Gastrointestinal Nausea 5 (7.35) 2 (2.94)
Abdominal pain
Central nervous system Headache 4 (5.88) 4 (5.88)
Renal Urinary tract infection 1 (1.47) 1 (1.47)
Neuromuscular Back pain 1 (1.47) 2 (2.94)
Other Other 11 (16.18) 6 (8.82)
  1. *Data were analyzed using the Pearson chi-squared test (p value = 0.29). react. reaction