Celecoxib-related gastroduodenal ulcer and cardiovascular events in a randomized trial for gastric cancer prevention

Table 1 Baseline characteristics of 1024 participants

	Celecoxib, n (%)	Placebo, n (%)	P
Male	238 (46.58)	235 (45.81)	0.81
Age (yr, means ± SD)	52.94 ± 6.51	52.93 ± 6.48	0.97
Smoking	146 (28.57)	142 (27.68)	0.75
Drinking	172 (33.66)	175 (34.11)	0.88
Hypertension	155 (30.33)	160 (31.19)	0.77

Table 2 Incidence and risk of side effects in two groups

	Celecoxib, n (%)	Placebo, n (%)	OR (95% CI)
Gastroduodenal ulcer	19 (3.72)	17 (3.31)	1.13 (0.58-2.22)
CV events	4 (0.86)	5 (1.06)	0.84 (0.23-3.15)
Main nonadjudicated side effects
Abdominal pain	8 (1.73)	13 (2.75)	0.62 (0.26-1.52)
Bloating	19 (4.10)	7 (1.48)	2.85 (1.19-6.84)
Constipation	9 (1.94)	15 (3.17)	0.61 (0.26-1.40)
Diarrhea	24 (5.18)	24 (5.07)	1.02 (0.57-1.83)
Dizziness	25 (5.40)	36 (7.61)	0.69 (0.41-1.17)
Gastric spasmus	15 (3.24)	15 (3.17)	1.02 (0.49-2.12)
Headache	26 (5.62)	23 (4.86)	1.16 (0.65-2.07)
Heartburn	29 (6.26)	23 (4.86)	1.31 (0.75-2.30)
Loss of appetite	25 (5.40)	16 (3.38)	1.63 (0.86-3.10)
Muscle pain	55 (11.88)	70 (14.80)	0.78 (0.53-1.13)
Nausea	14 (3.02)	17 (3.59)	0.84 (0.41-1.72)
Pain in the chest	16 (3.46)	17 (3.59)	0.96 (0.48-1.92)
Palpitations	22 (4.75)	16 (3.38)	1.43 (0.74-2.75)