Skip to main content

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