Table 5.

Secondary endpoints of the double-blind treatment period.

Variable	Placebo (n = 25)	Telotristat ethyl
		250 mg tid (n = 25)			500 mg tid (n = 25)
	Mean (s.d.)	Mean (s.d.)	P	95% CL	Mean (s.d.)	P	95% CL
BM frequency
Change from baseline in BM frequency averaged over 12 weeks, counts/day	0.05 (0.33)	−0.45 (0.69)	−	−	−0.60 (0.72)	−	−
Arithmetic mean treatment difference	−	−0.50	−	−0.81 to −0.19	−0.65	−	−0.96 to −0.33
Hodges–Lehmann estimator	−	−0.45	0.004	−0.72 to −0.17	−0.54	<0.001	−0.79 to −0.25
Stool consistency
Change from baseline in stool consistency averaged over 12 weeks (Bristol Stool Form scale)	0.01 (0.41)	−0.20 (0.70)	–	–	−0.60 (0.86)	–	–
Arithmetic mean treatment difference	−	−0.20	–	−0.53 to 0.13	−0.60	–	−0.99 to −0.22
Hodges–Lehmann estimator	−	−0.20	0.09	−0.45 to 0.02	−0.39	0.009	−0.82 to −0.12
Flushing
Change from baseline in daily cutaneous flushing episodes averaged over 12 weeks, counts/day	−0.33 (1.22)	−0.06 (0.98)	–	–	0.11 (2.10)	–	–
Arithmetic mean treatment difference	−	0.27	–	−0.36 to 0.90	0.45	–	−0.53 to 1.42
Hodges–Lehmann estimator	−	0.11	0.67	−0.17 to 0.61	0.02	0.58	−0.28 to 0.62
Abdominal pain
Change from baseline in abdominal pain averaged over 12 weeks, 11-point numeric rating scale	−0.06 (0.78)	−0.23 (0.97)	–	–	0.03 (0.77)	–	–
Arithmetic mean treatment difference	−	−0.17	–	−0.67 to 0.33	0.09	–	−0.35 to 0.53
Hodges–Lehmann estimator	−	0.06	0.61	−0.42 to 0.33	0.14	0.66	−0.39 to 0.51
Rescue short-acting SSA use
Change from baseline in rescue short-acting SSA use averaged over 12 weeks, counts/day	−0.01 (0.14)	−0.07 (0.35)	–	–	0.01 (0.10)	–	–
Arithmetic mean treatment difference	−	−0.05	–	−0.20 to 0.10	0.02	–	−0.05 to 0.09
Hodges–Lehmann estimator	−	0.00	0.45	0.00–0.00	0.000	0.98	0.00–0.00

BM, bowel movement; CL, confidence limits; s.d., standard deviation; SSA, somatostatin analog; tid, 3 times per day.