Adverse events and serious adverse events, according to intravenous iron treatment
| FDI (N=48) | FCM (N=49) | |
| Any AE | 44 (91.7%) | 44 (89.8%) |
| Most frequent AEs (≥10% in at least one treatment group) | ||
| Vitamin D deficiency | 11 (22.9%) | 17 (34.7%) |
| Hypophosphataemia | 1 (2.1%) | 14 (28.6%) |
| Nasopharyngitis | 8 (16.7%) | 10 (20.4%) |
| Headache | 9 (18.8%) | 5 (10.2%) |
| Arthralgia | 7 (14.6%) | 6 (12.2%) |
| Nausea | 6 (12.5%) | 1 (2.0%) |
| Fatigue | 5 (10.4%) | 4 (8.2%) |
| Any SAE | 5 (10.4%) | 6 (12.2%) |
| Abscess neck | 1 (2.1%) | 0 (0.0%) |
| Colitis ulcerative | 1 (2.1%) | 1 (2.0%) |
| Deep vein thrombosis | 1 (2.1%) | 0 (0.0%) |
| Hypophosphataemia | 1 (2.1%) | 0 (0.0%) |
| Intervertebral disc protrusion | 1 (2.1%) | 0 (0.0%) |
| Rectal ulcer haemorrhage | 1 (2.1%) | 0 (0.0%) |
| Hypersensitivity | 0 (0.0%) | 1 (2.0%) |
| Intermittent claudication | 0 (0.0%) | 1 (2.0%) |
| Migraine | 0 (0.0%) | 1 (2.0%) |
| Non-Hodgkin’s lymphoma | 0 (0.0%) | 1 (2.0%) |
| Subileus | 0 (0.0%) | 1 (2.0%) |
| TEAEs leading to drug withdrawal | 3 (6.3%) | 1 (2.0%) |
| Severity | ||
| Mild | 40 (83.3%) | 39 (79.6%) |
| Moderate | 19 (39.6%) | 20 (40.8%) |
| Severe | 4 (8.3%) | 6 (12.2%) |
Data are presented as n (%) for the safety analysis set.
AE, adverse event; FCM, ferric carboxymaltose; FDI, ferric derisomaltose; SAE, serious adverse event; TEAE, treatment-emergent adverse event.