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

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

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)
Gastrointestinal	Abdominal pain	5 (7.35)	2 (2.94)
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)

*Data were analyzed using the Pearson chi-squared test (p value = 0.29). react. reaction