Table 6.
List of adverse events
| Adverse events | FCM | Placebo |
|---|---|---|
| Heart failure recurrence (episodes) | 9 | 5 |
| Drug‐related | ||
| Serious/severe | 0 | 0 |
| General disorders and administration site conditions including fever | 3 | 0 |
| Skin and subcutaneous tissue disorders including rash and pruritus | 2 | 1 |
| Nervous system disorders including headache | 1 | 1 |
| Gastrointestinal disorders | 0 | 0 |
| Vascular disorders | 0 | 0 |
| Investigations | 0 | 0 |
| Ear and labyrinth disorders including dizziness | 1 | 1 |
| Injury, poisoning, and procedural complications | 0 | 0 |
| Cardiac disorders | 0 | 0 |
| Musculoskeletal disorders including myalgia/arthralgia/gout | 2 | 1 |
| Respiratory disorders | 1 | 0 |
| Total | 10 | 4 |
| Unrelated to drug | ||
| Death (from colon carcinoma and complications) | 1 | 0 |
| Moderate (NSTEMI with AF) | 1 | 0 |
| Mild (elevated creatinine, hyperglycaemia/hypoglycaemia, rib fracture, fall, haematuria, gynecomastia, UTI) | 3 | 3 |
| Total | 5 | 3 |
AF, atrial fibrillation; FCM, ferric carboxymaltose; NSTEMI, non‐ST segment elevation myocardial infarction; UTI, urinary tract infection.