Table 4

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

Adverse eventPlacebo (n=213)Enterosgel (n=214)
Nausea8 (3.8%) (1 s, 2 mo, 5 m)*8 (3.7%) (2 mo, 6 m)
Abdominal pain4 (1.9%) (2 mo, 2 m)3 (1.4%) (1 mo, 2 m)
Bloating3 (1.4%) (2 mo, 1 m)6 (2.8%) (3 mo, 3 m)
Constipation2 (0.9%) (1 s, 1 m)2 (0.9%) (1 s, 1 m)
Headache2 (0.9%) (2 m)2 (0.9%) (1 s,1 m)
Dry mouth2 (0.9%) (1 mo, 1 m)1 (0.5%) (1 m)
Backpain0 (0%)2 (0.9%) (1 s,1 mo)
Loss of appetite0 (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.