Table 3. Other efficacy parameter results (ITT population).

	Placebo, N=395	Linaclotide 290 μg, N=405	Difference	P value	NNT (95% CI)
Worst abdominal pain
Mean (11-point NRS scale)	4.4	3.7
aChange from baseline, meanb,c	−1.1	−1.9	−0.7	<0.0001
a% of patients with ≥30% decrease in worst abdominal pain for at least 6/12 weeksd	37.5	50.1	12.7	0.0003	7.9 (5.1, 17.1)
Abdominal discomfort
Mean (11-point NRS scale)	4.7	4.1
aChange from baseline, meanb,c	−1.2	−2.0	−0.7	<0.0001
% of patients with ≥30% decrease in abdominal discomfort for at least 6/12 weeksd	37.0	48.1	11.2	0.0013	8.9 (5.6, 22.8)
Abdominal bloating
Mean (11-point NRS scale)	5.3	4.6
aChange from baseline, meanb,c	−1.1	−1.9	−0.8	<0.0001
% of patients with ≥30% decrease in abdominal bloating for at least 6/12 weeksd	29.9	43.5	13.6	<0.0001	7.4 (5.0, 14.3)
Abdominal fullness
Mean (11-point NRS scale)	5.3	4.6
Change from baseline, meanb,c	−1.1	−2.0	−0.9	<0.0001
% of patients with ≥30% decrease in abdominal fullness for at least 6/12 weeksd	32.9	44.0	11.0	0.0012	9.1 (5.6, 23.0)
Abdominal cramping
Mean (11-point NRS scale)	4.1	3.5
Change from baseline, meanb,c	−1.1	−1.7	−0.6	<0.0001
% of patients with ≥30% decrease in abdominal cramping for at least 6/12 weeksd	39.5	49.9	10.4	0.0029	9.6 (5.8, 28.3)
CSBMs
Mean CSBMs/week	1.0	2.6
aChange from baseline, meanb,c	0.7	2.3	1.6	<0.0001
CSBM ≤24 h first dose (%)c	13.2	32.3	19.2	<0.0001	5.2 (4.0, 7.4)
a% of patients w/ CSBM rate increase ≥1 per week for at least 6/12 weeksd	29.6	48.6	19.0	<0.0001	5.3 (3.9, 8.1)
SBMs
Mean SBMs/week	3.2	6.0
aChange from baselineb,c	1.1	3.9	2.8	<0.0001
SBM ≤24 h after first dose (%)c	43.8	67.4	23.6	<0.0001	4.2 (3.3, 5.9)
% of patients w/ SBM rate increase ≥2 per week from baseline for at least 6/12 weeksd	29.4	57.5	28.2	<0.0001	3.6 (2.9, 4.6)
Stool consistency
Mean BSFS score (1–7)	3.1	4.5
aChange from baseline, meanb,c	0.7	2.1	1.4	<0.0001
Mean weekly % of SBMs without hard or lumpy stools (BSFS ≥3)	60.7	79.4	18.7	<0.0001
Straining
Mean straining score (1–5)	2.8	2.2
aChange from baseline, meanb,c	−0.7	−1.3	−0.7	<0.0001
Mean weekly % of SBMs without significant straining (i.e., score ≤3)	71.7	85.3	13.6	<0.0001
Constipation severity
Mean constipation severity score (1–5)	3.1	2.6
Change from baseline, meanb,c	−0.6	−1.2	−0.6	<0.0001
% of patients with decrease of ≥1 for at least 6/12 weeksd	42.5	59.5	17.0	<0.0001	5.9 (4.2, 9.9)
IBS severity
Mean IBS severity score (1–5)	3.1	2.7
Change from baseline, meanb,c	−0.5	−1.0	−0.5	<0.0001
% of patients with decrease of ≥1 for at least 6/12 weeksd	37.5	56.3	18.8	<0.0001	5.3 (3.9, 8.3)
Adequate relief
% of patients reporting adequate relief of IBS symptoms for at least 75% of the weeks (i.e., 9/12 weeks)d	21.3	36.8	15.5	<0.0001	6.4 (4.6, 10.7)
% of patients reporting adequate relief of IBS symptoms for at least 50% of the weeks (i.e., 6/12 weeks)d	34.2	48.9	14.7	<0.0001	6.8 (4.7, 12.6)
Degree of reliefe
% of patients reporting “Somewhat Relieved,” “Considerably Relieved,” or “Completely Relieved” for 100% of the weekly scores or “Considerably Relieved” or “Completely Relieved” for at least 50% of the weekly scoresd	24.3	41.2	16.9	<0.0001	5.9 (4.3, 9.5)

BSFS, Bristol Stool Forms Scale; CI, confidence interval; CSBM, complete SBM; IBS, irritable bowel syndrome; ITT, intent-to-treat; NNT, number needed to treat; NRS, numerical rating scale; SBM, spontaneous bowel movement.

^aSecondary end point.

^bChanges from baseline are the least-squares means from the analysis of covariance (ANCOVA) model.

^cP values were based on a comparison of linaclotide vs. the placebo group using the ANCOVA model.

^dP values were based on a comparison of linaclotide vs. the placebo group using the Cochran–Mantel–Haenszel test.

^eDegree of Relief scale: 1=completely relieved; 2=considerably relieved; 3=somewhat relieved; 4=unchanged; 5=somewhat worse; 6=considerably worse; 7=as bad as I can imagine.