Table 4.

Treatment-emergent adverse events in study subjects

Subjects Experiencing, N (%)	Placebo (n = 23)	Atrasentan
		0.25 mg (n = 22)	0.75 mg (n = 22)	1.75 mg (n = 22)
Any adverse event	13 (57%)	16 (73%)	16 (73%)	19 (86%)a
Any adverse event at least possibly related to study drug	5 (22%)	8 (36%)	6 (27%)	13 (59%)b
Any severe adverse event	0	1 (5%)	0	1 (5%)
Any serious adverse event	0	1 (5%)	3 (14%)	1 (5%)
Any adverse event leading to discontinuation of study drug	0	0	2 (9%)	2 (9%)
Deaths	0	0	0	0
Most commonly reported adverse effectsc
peripheral edema	2 (9%)	3 (14%)	4 (18%)	10 (46%)d
diarrhea	2 (9%)	1 (5%)	3 (14%)	0
dizziness	0	3 (14%)	2 (9%)	1 (5%)
urinary tract infection	1 (4%)	0	2 (9%)	3 (14%)
headache	0	2 (9%)	1 (5%)	2 (9%)
cough	1 (4%)	1 (5%)	2 (9%)	0
hypertension	1 (4%)	1 (5%)	1 (5%)	1 (5%)
hypoglycemia	0	3 (14%)	0	1 (5%)
hypotension	1 (4%)	0	1 (5%)	2 (9%)

^aP = 0.047 versus placebo.

^bP = 0.016 versus placebo.

^cReported in ≥5% of subjects.

^dP = 0.007 versus placebo.