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Table 4 Adverse drug reactions that occurred during the study

From: Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial

  Pelubiprofen (n =77) Celecoxib (n =68)  
Patients, n (%) Events, n Patients, n (%) Events, n p-value*
Total number of patients 24 (31.2) 34 14 (20.6) 17 0.15
Gastrointestinal 16 (20.8) 20 6 (8.8) 6 0.045
  Anorexia 2 (2.6) 2 1 (1.47) 1  
  Nausea 1 (1.3) 2 2 (2.94) 2  
  Indigestion 2 (2.6) 2 1 (1.47) 1  
  Epigastric discomfort 2 (2.6) 2 0 (0.0) 0  
  Abdominal pain 9 (11.7) 9 2 (2.94) 2  
  Diarrhea 1 (1.3) 1 0 (0.0) 0  
  Constipation 2 (2.6) 2 0 (0.0) 0  
Systemic 8 (10.4) 10 3 (4.4) 3 0.17
  Facial edema 5 (6.49) 5 1 (1.5) 1  
  Edema 3 (3.9) 4 1 (1.5) 1  
  Weight gain 0 (0.0) 0 1 (1.5) 1  
  Pain 1 (1.3) 1 0 (0.0) 0  
Respiratory 2 (2.6) 2 1 (1.5) 1 0.63
Nervous system 0 (0.0) 0 1 (1.5) 1 0.29
Skin and appendage 0 (0.0) 0 1 (1.5) 1 0.29
Hepatobiliary 1 (1.3) 1 1 (1.5) 2 0.49
Reproductive system 1 (1.3) 1 0 (0.0) 0 0.35
Cardiovascular 0 (0.0) 0 1 (1.5) 1 0.29
Infection 0 (0.0) 0 1 (1.5) 1 0.29
Peripheral vascular 0 (0.0) 0 1 (1.5) 1 0.29
  1. *p-value by the chi-square test: difference between the proportions of patients that developed an adverse event.