Summary of secondary variables derived from the daily diary data: mean absolute change from baseline (number of days) normalised to a 28 day interval (intention to treat population, n=520)
Mean absolute change | ||||||
---|---|---|---|---|---|---|
Weeks 1–4 | Last 28 days | |||||
Tegaserod (n=259) | Placebo (n=253) | Difference (95% CI) [p value] | Tegaserod (n=253) | Placebo (n=253) | Difference (95% CI) [p value] | |
*n=253; †n=252; ‡n=251; §n=250. | ||||||
At least moderate abdominal pain/discomfort | −4.2 | −2.8 | −1.3 (−2.8,0.2) [0.1029] | −7.4 | −5.7 | −1.5 (−3.2,0.2) [0.0134] |
At least moderate bloating | −3.9* | −2.4† | −1.3 (−2.8,0.2) [0.0825] | −6.1 | −4.7† | −1.2 (−3.0,0.5) [0.2624] |
No of bowel movements | −4.5 | −2.8 | −1.7 (−2.6,−0.8) [0.0002] | −4.2 | −3.8 | −0.3 (−1.3,0.8) [0.4018] |
>3 bowel movements | 0.3 | 0.1 | 0.1 (−0.3,0.5) [0.1933] | 0.1 | −0.1 | 0.1 (−0.2,0.4) [0.4778] |
Hard or lumpy stools | −6.6 | −2.6‡ | −3.9 (−5.6,−2.3) [<0.0001] | −6.8 | −4.2§ | −2.5 (−4.2,−0.9) [0.0200] |
Normal stools | 3.2 | 2.6‡ | 0.6 (−1.2,2.3) [0.6257] | 5.5 | 4.4 | 1.0 (−0.9, 2.8) [0.8902] |
Urgency | −2.0‡ | −0.7† | −1.2 (−2.7,0.2) [0.2828] | −0.7† | 0.0† | −0.7 (−2.3,1.0) [0.9790] |
Straining | 4.6* | 2.8‡ | 1.7 (0.1,3.4) [0.0234] | 5.9 | 5.0‡ | 0.7 (−1.2,2.6) [0.2172] |
Sensation of incomplete evacuation | 2.9* | 1.5† | 1.4 (0.0, 2.8) [0.0754] | 3.9 | 2.6† | 1.3 (−0.4,3.0) [0.2877] |