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Table 3 Adverse events 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 adverse events 39 (50.6) 62 25 (36.8) 33 0.09
Gastrointestinal 21 (27.3) 29 7 (10.3) 8 0.01
  Anorexia 2 (2.6) 2 1 (1.47) 1  
  Nausea 2 (2.6) 3 3 (4.41) 3  
  Vomiting 1 (1.3) 1 1 (1.47) 1  
  Indigestion 3 (3.9) 2 1 (1.47) 1  
  Epigastric discomfort 4 (5.2) 4 0 (0.0) 0  
  Abdominal pain 10 (13.0) 10 2 (2.94) 2  
  Diarrhea 4 (5.19) 5 0 (0.0) 0  
  Constipation 2 (2.6) 2 0 (0.0) 0  
Systemic 11 (14.3) 13 4 (5.9) 4 0.10
  Facial edema 5 (6.49) 5 1 (1.5) 1  
  Edema 4 (5.19) 5 1 (1.5) 1  
  Chest discomfort 1 (1.3) 1 0 (0.0) 0  
  Nipple pain 0 (0.0) 0 1 (1.5) 1  
  Weight gain 0 (0.0) 0 1 (1.5) 1  
  Pain 1 (1.3) 1 0 (0.0) 0  
  Fatigue 1 (1.3) 1 0 (0.0) 0  
Anemia 0 (0.0) 0 1 (1.5) 1 0.29
Respiratory 6 (7.8) 6 4 (5.9) 4 0.65
Nervous system 2 (2.6) 2 4 (5.9) 6 0.32
Skin and appendage 3 (3.9) 4 1 (1.5) 1 0.37
Musculoskeletal 1 (1.3) 1 2 (2.9) 2 0.49
Hepatobiliary 1 (1.3) 1 1 (1.5) 2 0.92
Reproductive system 1 (1.3) 1 1 (1.5) 2 0.92
Cardiovascular 1 (1.3) 1 1 (1.5) 1 0.92
Infection 0 (0.0) 0 1 (1.5) 1 0.29
Eye 1 (1.3) 1 0 (0.0) 0 0.35
Urinary 1 (1.3) 1 0 (0.0) 0 0.35
Psychiatric 1 (1.3) 2 0 (0.0) 0 0.35
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.
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BMC Musculoskeletal Disorders

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