Table 2.

Adverse events

Organ System ClassAll Adverse EventsSerious Adverse Events
Ferric Citrate n (%)Standard of Care n (%)Ferric Citrate n (%)Standard of Care n (%)
Blood and lymphatic system7 (5)2 (3)
Cardiac disorders13 (10)8 (12)5 (4)3 (4)
Endocrine disorders1 (1)
Eye disorders4 (3)
GI disorders63 (47)9 (13)1 (1)3 (4)
General13 (10)7 (10)1 (1)1 (2)
Hepatobiliary3 (4)1 (2)
Immune system1 (1)
Infections and infestations40 (30)26 (38)3 (2)6 (9)
Injury, poisoning9 (7)7 (10)1 (1)
Investigations2 (2)2 (3)
Metabolism13 (10)6 (9)1 (1)2 (3)
Musculoskeletal8 (6)8 (12)2 (2)1 (2)
Neoplasms7 (5)1 (2)
Nervous system7 (5)4 (6)1 (1)3 (4)
Psychiatric1 (1)3 (4)
Renal and urinary10 (7)7 (10)4 (3)6 (9)
Reproductive2 (2)
Respiratory17 (13)7 (10)3 (2)2 (3)
Skin4 (3)2 (3)
Vascular9 (7)6 (9)2 (2)3 (4)