Table 4.

(a) Incidence of one or more hospitalizations related to adverse events; (b) cumulative number of hospitalizations related to adverse events, during the safety period^a (safety population)

	High ferritin FCM (n = 154) (138.5 PY)	Low ferritin FCM (n = 150) (129.0 PY)	Oral iron (n = 312) (242.8 PY)
(a) Incidence of events
Hospitalization related to an adverse event
No. of patients (%)	33 (21.4)	35 (23.3)	57 (18.3)
No. of patients with events per 100 PY	23.8	27.1	23.5
Hospitalization related to an adverse event classified as a cardiac disorder
No. of patients (%)	7 (4.5)	6 (4.0)	13 (4.2)
No. of patients with events per 100 PY	5.1	4.7	5.4
Hospitalization related to an adverse event classified as an infection
No. of patients (%)	5 (3.2)	4 (2.7)	12 (3.8)
No. of patients with events per 100 PY	3.6	3.1	4.9
(b) Cumulative number of events
Hospitalization related to an adverse event
No. of events	50	48	95
No. of events per 100 PY	36.1	37.2	39.1
Hospitalization related to an adverse event classified as a cardiac disorder
No. of events	9	6	16
No. of events per 100 PY	6.5	4.7	6.6
Hospitalization related to an adverse event classified as an infection
No. of events	5	4	20
No. of events per 100 PY	3.6	3.1	8.2

The safety population included all patients who received one or more doses of randomized treatment.

PY, patient-years.

^aThe safety period included all events up to the point at which another anemia therapy was initiated and/or the randomized study medication was discontinued.