Table 2.

Analysis of study period responders in double-blind phase (ITT population): the table shows responder rates for composite (primary outcome) and individual stool consistency and abdominal pain

Study period responder	Placebo	Enterosgel	OR (95% CI)*	P value
Primary outcome
Observed data (excluding weeks with <4 values)	52/214 (24.3)	80/214 (37.4)	1.95 (1.28 to 2.99)	0.0020
Observed data (excluding weeks with <7 values)	37/206 (18.0)	61/204 (29.9)	2.03 (1.26 to 3.25)	0.0035
Stool consistency
Observed data (excluding weeks with <4 values)	91/214 (42.5)	125/214 (58.4)	1.97 (1.33 to 2.92)	0.0007
Observed data (excluding weeks with <7 values)	67/206 (32.5)	99/204 (48.5)	2.02 (1.34 to 3.05)	0.0007
Abdominal pain
Observed data (excluding weeks with <4 values)	86/214 (40.2)	114/214 (53.3)	1.80 (1.22 to 2.67)	0.0034
Observed data (excluding)	70/206 (34.0)	94/204 (46.10)	1.76 (1.16 to 2.65)	0.0074

Data are reported as number of patients, proportion (%), and OR (95% CI).

*Adjusted for age and sex.