A randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation

Table 1 Patient demographic and baseline characteristics (ITT population)

Demographic variable	Tegaserod 6 mg b.i.d.	Placebo
	(n = 304)	(n = 303)
Age (yr)
Median	34.5	35
Range	18-80	18-78
Age group, years (n, %)
< 35	152 (50.0)	151 (49.8)
35-64	132 (43.4)	135 (44.6)
≥ 65	20 (6.6)	17 (5.6)
Sex (n, %)
Male	70 (23.0)	61 (20.1)
Female	234 (77.0)	242 (79.9)
Race (n, %)
Oriental	303 (99.7)	303 (100.0)
Other	1 (0.3)	0
Mean duration of constipation symptoms, months (SD)	100.3 (90.7)	94.9 (93.1)

Table 2 Treatment differences in change from baseline in number of CSBMs/wk for wk 1-4 (ITT population)

Timeperiod		Tegaserod 6mg b.i.d.n = 304	Placebon = 303
wk 1-4	n	303	303
	Mean (SD)	1.38 (1.759)	0.89 (1.444)
	Adjusted mean1	1.39	0.91
	Median	0.75	0.25
	Min, max	-2.0, 9.0	-1.5, 7.5
	Tegaserod-placebo	0.48
	(95% CI)2	(0.23, 0.73)
	P value3	0.0002
wk 1	Tegaserod–placebo	0.34
	(95% CI)2	(0.05, 0.64)
	P value3	0.0226
wk 2	Tegaserod-placebo	0.54
	(95% CI)2	(0.24, 0.84)
	P value3	0.0004
wk 3	Tegaserod–placebo	0.57
	(95% CI)2	(0.27, 0.86)
	P value3	0.0002
wk 4	Tegaserod–placebo	0.47
	(95% CI)2	(0.17, 0.77)
	P value3	0.002

CSBM: complete spontaneous bowel movement; SD: standard deviation; CI: confidence interval. Change from baseline (cfb) = post-baseline–baseline. A positive cfb indicates an increase in the number of CSBMs/wk.

¹Adjusted mean cfb. Calculated from least square mean estimate of repeated measures analysis.

²Treatment difference (> 0 favors tegaserod).

³Repeated measures model: cfb in number of CSBMs/wk = treatment (patient) + week + center + baseline + baseline *week + treatment *week.

Table 3 Incidence of most frequent AEs, regardless of relationship to study drug (safety population)

Adverse event	Tegaserod 6 mg b.i.d.(n = 303) (%)	Placebo(n = 303) (%)
Diarrhea	11 (3.6)	5 (1.7)
Abdominal pain	5 (1.7)	5 (1.7)
Nasopharyngitis	1 (0.3)	7 (2.3)
Transaminases increased	3 (1.0)	1 (0.3)
Nausea	1 (0.3)	3 (1.0)
Abdominal distension	3 (1.0)	0
Dizziness	2 (0.7)	0
Leukopenia	1 (0.3)	1 (0.3)
Urinary tract inflammation	1 (0.3)	1 (0.3)
Abdominal pain upper	0	2 (0.7)