Table 4. Treatment-emergent adverse events (safety population).

Adverse event (preferred term)	Placebo (N=396), n (%)	Linaclotide 290 μg (N=406), n (%)	P value
Patients with at least 1 TEAE	210 (53.0)	228 (56.2)	0.3949
Diarrhea	14 (3.5)	79 (19.5)	<0.0001
Abdominal pain	10 (2.5)	22 (5.4)	0.0462
Flatulence	6 (1.5)	20 (4.9)	0.0084
Headache	14 (3.5)	20 (4.9)	0.3825
Abdominal distension	3 (0.8)	9 (2.2)	0.1434

Treatment-emergent adverse events (TEAEs) reported in ≥2% of linaclotide-treated patients and at an incidence greater than reported in placebo-treated patients during the treatment period.

P value was based on a Fisher's exact test comparing linaclotide and placebo.