Table 3.

Gastrointestinal AEs

AE category	Tenapanor			Placebo, n=82	Tenapanor
	3 mg Twice Daily, n=74	10 mg Twice Daily, n=73	30 mg Twice Daily Titration, n=71		3 mg Twice Daily, n=25	10 mg Twice Daily, n=23	30 mg Twice Daily Titration, n=34
RTP
Gastrointestinal disorders	24 (32.4)	35 (47.9)	40 (56.3)
Gastrointestinal disorders by preferred terma
Diarrhea	22 (29.7)	30 (41.1)	34 (47.9)
Mild	9 (12.2)	11 (15.1)	14 (19.7)
Moderate	12 (16.2)	16 (21.9)	17 (23.9)
Severe	1 (1.4)	3 (4.1)	3 (4.2)
Vomiting	2 (2.7)	3 (4.1)	3 (4.2)
Flatulence	2 (2.7)	3 (4.1)	2 (2.8)
Abdominal discomfort	1 (1.4)	4 (5.5)	1 (1.4)
Abdominal distension	0 (0.0)	1 (1.4)	2 (2.8)
Abdominal pain	0 (0.0)	3 (4.1)	0 (0.0)
Abdominal pain upper	2 (2.7)	1 (1.4)	0 (0.0)
Frequent bowel movements	0 (0.0)	3 (4.1)	0 (0.0)
Nausea	2 (2.7)	1 (1.4)	0 (0.0)
Defecation urgency	0 (0.0)	2 (2.7)	0 (0.0)
RWP
Gastrointestinal disorders				4 (4.9)	0 (0.0)	0 (0.0)	2 (5.9)
Gastrointestinal disorders by preferred terma
Diarrhea				2 (2.4)	0 (0.0)	0 (0.0)	1 (2.9)
Mild				1 (1.2)	0 (0.0)	0 (0.0)	1 (2.9)
Moderate				1 (1.2)	0 (0.0)	0 (0.0)	0 (0.0)
Severe				0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Abdominal pain				0 (0.0)	0 (0.0)	0 (0.0)	1 (2.9)
Food poisoning				0 (0.0)	0 (0.0)	0 (0.0)	1 (2.9)

Data are number of patients experiencing AE (%). AE, adverse event.

^aData shown for AEs that were experienced by >2% of patients in any group.