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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.