Table 3.

AEs and related AEs by frequency (safety population)

AE Preferred TermFerumoxytol (n=80)Iron Sucrose (n=82)
EventsPatients n (%)EventsPatients n (%)
Overall AEs in patients (AEs occurring in >2% of patients)8638 (47.5)16153 (64.6)
 Nasopharyngitis33 (3.8)22 (2.4)
 Urinary tract infection43 (3.8)76 (7.3)
 Muscle spasms44 (5.0)126 (7.3)
 Myalgia0022 (2.4)
 Pain in extremity11 (1.3)22 (2.4)
 Injection site pain11 (1.3)22 (2.4)
 Edema peripheral22 (2.5)66 (7.3)
 Constipation22 (2.5)33 (3.7)
 Diarrhea22 (2.5)21 (1.2)
 Nausea66 (7.5)33 (3.7)
 Headache33 (3.8)22 (2.4)
 Parosmia00314 (4.9)
 Hypotension32 (2.5)188 (9.8)
 Hyperkalemia33 (3.8)11 (1.2)
 Hypoglycemia22 (2.5)43 (3.7)
 Cough33 (3.8)00
 Anemia22 (2.5)11 (1.2)
Overall related AEs88 (10.0)4613 (15.9)
 Anaphylactic reaction11 (1.3)00
 Dysgeusia11 (1.3)00
 Feeling hot11 (1.3)11 (1.2)
 Flushing11 (1.3)00
 Headache11 (1.3)00
 Injection site hematoma11 (1.3)00
 Injection site pain11 (1.3)22 (2.4)
 Nausea11 (1.3)00
 Cold sweat0011 (1.2)
 Constipation0011 (1.2)
 Diarrhea0021 (1.2)
 Hypotension0063 (3.7)
 Injection site hemorrhage0011 (1.2)
 Myalgia0011 (1.2)
 Parosmia00303 (3.7)
 Unresponsive to stimuli0011 (1.2)