Table 5. TEAEs ^a after the first dose of study drug and RFBM within 4 hours of dosing.

	Placebo (n = 363)			Methylnaltrexone (n = 900)
	No RFBM within 4 hours of 1 st dose (n = 331)	RFBM within 4 hours of 1 st dose (n = 32)	P-Value	No RFBM within 4 hours of 1 st dose (n = 674)	RFBM within 4 hours of 1 st dose (n = 226)	P-Value
Abdominal pain, n (%)	3 (0.9)	0	NS	28 (4.2)	24 (10.6)	0.0008
Abdominal pain, upper, n (%)	3 (0.9)	0	NS	4 (0.6)	7 (3.1)	0.0074
Diarrhea, n (%)	0	0	NS	6 (0.9)	8 (3.5)	0.0101
Nausea, n (%)	3 (0.9)	0	NS	16 (2.4)	14 (6.2)	0.0092
Hyperhidrosis, n (%)	1 (0.3)	0	NS	13 (1.9)	7 (3.1)	NS

NS = not significant, P>0.05; RFBM = rescue-free bowel movement; TEAEs = treatment-emergent adverse events.

^a Reported by ≥2% of patients in any treatment group.