Table 4.

Adverse events (AEs) during the double-blind phase in the safety population; possibly, probably or definitely related to treatment

Adverse event	Placebo (n=213)	Enterosgel (n=214)
Nausea	8 (3.8%) (1 s, 2 mo, 5 m)*	8 (3.7%) (2 mo, 6 m)
Abdominal pain	4 (1.9%) (2 mo, 2 m)	3 (1.4%) (1 mo, 2 m)
Bloating	3 (1.4%) (2 mo, 1 m)	6 (2.8%) (3 mo, 3 m)
Constipation	2 (0.9%) (1 s, 1 m)	2 (0.9%) (1 s, 1 m)
Headache	2 (0.9%) (2 m)	2 (0.9%) (1 s,1 m)
Dry mouth	2 (0.9%) (1 mo, 1 m)	1 (0.5%) (1 m)
Backpain	0 (0%)	2 (0.9%) (1 s,1 mo)
Loss of appetite	0 (0%)	2 (0.9%) (2 m)

AE listed in descending order of frequency in the placebo group. The AEs listed were reported in two or more cases in either treatment group.

*AE severity; s=severe, mo=moderate, m=mild.