Table 6.

Incidence of treatment-emergent AEs occurring in ≥5% of subjects in any treatment group (safety population; treatment and follow-up periods)^a

AE	Treatment Arm
	Placebo (n = 21)	Fermagate 1 g (n = 21)	Fermagate 2 g (n = 21)
Diarrhea	2 (9.5)	3 (14.3)	10 (47.6)
Discolored feces	1 (4.8)	6 (28.6)	8 (38.1)
Vomiting, n (%)	2 (9.5)	0 (0)	3 (14.3)
Abdominal distension, n (%)	1 (4.8)	2 (9.5)	1 (4.8)
Dyspepsia, n (%)	0 (0)	1 (4.8)	3 (14.3)
Nausea, n (%)	2 (9.5)	0 (0)	2 (9.5)
Loose stools, n (%)	0 (0.0)	2 (9.5)	1 (4.8)
Arteriovenous fistula occlusion	0 (0.0)	0 (0.0)	2 (9.5)
Procedural hypotension	0 (0.0)	0 (0.0)	2 (9.5)

^aValues are presented as n (%).