|
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
|
- *p-value by the chi-square test: difference between the proportions of patients that developed an adverse event.