Table 3.

Cumulative number of adverse events and serious 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)
Adverse events
No. of patients	126	129	255
No. of events	607	553	1069
No. of events per 100 PY	438.3	428.7	440.3
Adverse events with suspected relation to study drug
No. of patients	22	23	89
No. of events	43	39	140
No. of events per 100 PY	31.0	30.2	57.7
Serious adverse events
No. of patients	39	36	59
No. of events	60	51	99
No. of events per 100 PY	43.3	39.5	40.8
Serious adverse events with suspected relation to study drug
No. of patients	0	0	1
No. of events	0	0	1
No. of events per 100 PY	0	0	0.4
Adverse events with suspected relation to study drug leading to study drug discontinuation
No. of patients (%)	1 (0.7)	2 (1.3)	23 (7.5)
No. of events	1	2	26
No. of events per 100 PY	0.7	1.6	10.7
Median time (days) to first event	242	155	29

The safety population included all patients who received one or more doses dose 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.